[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breastfeeding\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breastfeeding":32},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,66,0,25,[9,51,74,98,125,155,184,210,242,266,312,341,373,399,428,466,504,527,553,573,599,625,653,682,710],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100643771","development-of-a-multidimensional-predictive-model-of-dystocic-labor-association-of-physical-condition-and-psychosocial-factors-with-the-birth-process-and-breastfeeding-success-100643771",false,"NCT07635771","Development of a Multidimensional Predictive Model of Dystocic Labor. Association of Physical Condition and Psychosocial Factors With the Birth Process and Breastfeeding Success.","Development of a Multidimensional Predictive Model of Dystocic Labor (MPM-PD): Pilot Study on the Association of Physical Condition and Psychosocial Factors With the Completion of Labor and the Success of Breastfeeding.","MPM-PD","Inclusion Criteria:\n\n* Pregnant women aged 18 years or older\n* Low-to-moderate risk pregnancy\n* Singleton pregnancy\n* Third trimester of pregnancy (\\>28 gestational weeks)\n* Understanding of the official languages\n* Acceptance and signing of the participant information sheet and informed consent form\n* Availability of an electronic device to complete the forms\n\nExclusion Criteria:\n\n* Medical contraindication for light physical activity\n* Severe cardio-respiratory or musculoskeletal pathology\n* Elective cesarean section\n* Severe fetal malformations","FEMALE","18 Years",{"count":21,"type":22},420,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn how a pregnant woman's physical fitness and emotional well-being can help predict the type of birth she will have (such as a natural vaginal birth versus a cesarean section or a birth requiring medical assistance). The study focuses on pregnant women in their third trimester (after 28 weeks of pregnancy).\n\nThe main questions the study aims to answer are:\n\n* Can simple tests of physical strength and questions about emotions (like fear of childbirth) help health professionals predict if a birth might have complications or lack of progress?\n* Do a woman's physical activity and confidence levels during pregnancy affect her ability to successfully breastfeed her baby for up to 6 months?\n\nParticipants will be asked to:\n\n* Perform two simple physical tests during a clinic visit: a hand-grip test (dynamometry test) and a test to see how many times they can stand up from a chair in 30 seconds (Chair Stand Test, CST).\n* Complete surveys about their daily physical activity (PPAQ-S), their feelings and fears regarding childbirth (WDEQ-A), and how confident they feel about handling the final stage of birth and the pushing phase (CBSEI-16).\n* Answer brief follow-up phone calls one month and six months after the birth to talk about how breastfeeding is going.",[26,27,28,29,30,31,32],"Labor and Childbirth","Labor (Obstetrics)--Complications","Hand Strength","Physical Conditioning, Human","Tocophobia","Self Efficacy","Breastfeeding",[34,35,28,36,37,30,31,32],"Labor, Obstetric","Obstetric Labor Complications","Dynamometry","Physical condition","RECRUITING","2026-06-18",{"date":41,"type":42},"2026-06-23","ACTUAL",{"date":44,"type":42},"2026-06-10",{"date":46,"type":22},"2027-12",{"name":48,"class":49},"Institut Investigacio Sanitaria Pere Virgili","OTHER",1,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":50},"100641736","the-effect-of-podcast-breastfeeding-training-on-mothers-of-preterm-infants-100641736","NCT07660965","The Effect of Podcast Breastfeeding Training on Mothers of Preterm Infants","The Effect of Podcast Breastfeeding Training on Breastfeeding Outcomes of Mothers of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit (NICU): A Randomized Controlled Study","Inclusion Criteria:\n\n* The mother must volunteer to participate in the study,\n* The mother must be 18 years of age or older\n* After being accepted into the study, the mother must express her intention to breastfeed her baby\n* The mother must be able to speak and read Turkish\n* The mother's baby being between 32 and 37 weeks gestation\n\nExclusion Criteria:\n\n* Illegal drug and tobacco use by the mother\n* The mother's use of alcohol during pregnancy and after childbirth\n* Active tuberculosis in the mother\n* The presence of Herpes simplex virus lesions on the mother's breast\n* The presence of a maternal psychiatric disorder\n* Having prior experience breastfeeding a preterm infant\n* Having a condition that prevents breastfeeding\n* Mothers who have had multiple births.",{"count":59,"type":22},56,"INTERVENTIONAL",[62],"NA","The aim of this study is to examine the effect of breastfeeding education provided via podcast to mothers of preterm infants admitted to the neonatal intensive care unit on the mothers' breastfeeding success, awareness, motivation, self-efficacy, and perception of insufficient milk supply. The research aims to help mothers overcome challenges in the breastfeeding process by increasing their knowledge levels and to strengthen their confidence in this process. Thus, the goal is to better meet the nutritional needs of preterm infants and to improve mothers' breastfeeding experiences in a positive direction.",[32],"2026-06-16",{"date":67,"type":42},"2026-06-22",{"date":69,"type":42},"2025-07-20",{"date":71,"type":22},"2026-06-30",{"name":73,"class":49},"Dilek Kucuk Alemdar",{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":60,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":50},"100641755","prevention-of-postpartum-smoking-relapse-and-related-health-consequences-by-breastfeeding-promotion-100641755","NCT07661550","Prevention of Postpartum Smoking Relapse and Related Health Consequences by Breastfeeding Promotion","Inclusion Criteria:\n\n* Be pregnant\n* Be 18 years or older\n* Have quit smoking cigarettes during this pregnancy\n* Be willing to receive infant care and breastfeeding education\n* Be able to read, listen, and talk in English\n\nExclusion Criteria:\n\n* Medical conditions contraindicating breastfeeding, such as HIV infection, active tuberculosis, and breast removal\n* Current heavy drinking (≥4 standard drinks on any day or ≥8 standard drinks per week)",true,{"count":82,"type":22},280,[62],"The objective of this randomized controlled trial is to examine the efficacy of a new intervention to prevent postpartum smoking relapse and related health consequences through breastfeeding promotion. After the pre-test, ex-smokers who are still abstinent from smoking will be randomized into either the breastfeeding intervention or the attention placebo control group. The outcomes are postpartum smoking relapse, breastfeeding practices, and maternal and child health.",[86,32],"Smoking ( Cigarette)",[88,89,90],"Pregnancy","Postpartum","Relapse",{"date":67,"type":42},{"date":93,"type":42},"2026-01-01",{"date":95,"type":22},"2031-07-31",{"name":97,"class":49},"State University of New York at Buffalo",{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":18,"minAge":105,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":50},"100509642","breastfeeding-failure-influence-of-smartphone-use-and-distraction-factors-100509642","NCT05916079","Breastfeeding Failure: Influence of Smartphone Use and Distraction Factors","BRIEFCALL","Inclusion Criteria:\n\n* breastfeeding mothers of Newborn breastfed infant born in the maternity ward of the Amiens-Picardie University Hospital\n\nExclusion Criteria:\n\n* Mother refusing to participate in the study; hospitalization during the neonatal period","18 Months",{"count":107,"type":22},300,"The benefits of breastfeeding no longer need to be proven. Many studies have shown its positives effects on both infants and mothers. Exclusive breastfeeding is thus recommended within the first six months of life.\n\nExcessive screen use has been shown to be harmful in many aspects of daily life. The impact upon the relation between mother and newborn infant is poorly studied.\n\nThe study aims to evaluate the impact of the use of smartphones on the success and duration of breastfeeding.",[32,110],"Smartphone",[32,112,113,114,115],"smartphone","screen","distraction","developmental care","2026-06-12",{"date":118,"type":42},"2026-06-15",{"date":120,"type":42},"2023-02-16",{"date":122,"type":22},"2026-06",{"name":124,"class":49},"Centre Hospitalier Universitaire, Amiens",{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":80,"sex":18,"minAge":19,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":60,"phases":135,"briefSummary":136,"conditions":137,"keywords":141,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":50},"100634695","kangaroo-care-breastfeeding-success-and-maternal-role-100634695","NCT07543029","Kangaroo Care: Breastfeeding Success and Maternal Role","The Effect of Kangaroo Mother Care Applied in the Early Postpartum Period to Primiparous Mothers on Breastfeeding Success and Perception of the Maternal Role","Inclusion Criteria:\n\n* For mothers:\n\n  * It must be the mother's first birth,\n  * Birth must have been vaginal,\n  * The mother must be healthy,\n  * The mother must voluntarily participate in the study,\n  * The mother must not have any communication-impairing conditions (language, cognitive problems, etc.),\n\nFor babies:\n\n* Birth weight must be between 2500-4000 grams;\n* The newborn must be healthy,\n* Exclusively breastfed,\n* The newborn must be at term gestation (38-42 weeks),\n* The newborn's Apgar score at 1 and 5 minutes must be above 7,\n* The newborn must not have any health problems that could affect breastfeeding (cleft palate, cleft lip, esophageal atresia, etc.).\n\nExclusion Criteria:\n\n\\-","49 Years",{"count":134,"type":22},112,[62],"Purpose: This is a randomized controlled trial designed to investigate the effects of Kangaroo Mother Care (KMC) applied in the early postpartum period to primiparous mothers on breastfeeding success and the perception of the maternal role.\n\nMethodology and Sample:\n\nSetting and Period: The study will be conducted at the Bucak State Hospital Delivery Unit between June 2025 and June 2026.\n\nSample Size: Based on G\\*Power analysis (alpha=0.05, power=80%, effect size d=0.566), a total of 112 mothers (56 intervention, 56 control) will be included, accounting for a 10% potential attrition rate. Participants will be assigned to groups using the sealed envelope method and randomization via www.random.org.\n\nIntervention:\n\nExperimental Group: Following routine care, the newborn will be placed in a \"chest-to-chest\" position on the mother's bare chest for Kangaroo Care. Intermittent KMC will be maintained for 24 hours, during which breastfeeding attempts will be supported.\n\nControl Group: Mothers and newborns will receive only the hospital's routine care (standard skin-to-skin contact and breastfeeding support).\n\nData Collection Tools:\n\nPersonal Information Form, Semantic Differential Scale-Myself as a Mother (to measure maternal role perception), LATCH Breastfeeding Assessment Tool (to evaluate breastfeeding success).",[32,138,139,140],"Maternal Role","Postpartum Care","Kangaroo Care",[142,143,144,145,146],"Primiparity","newborn","breastfeeding","maternal role","kangaroo care","2026-06-11",{"date":118,"type":42},{"date":150,"type":42},"2025-06-01",{"date":152,"type":22},"2026-12-30",{"name":154,"class":49},"Recep Tayyip Erdogan University",{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":80,"sex":18,"minAge":19,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":60,"phases":165,"briefSummary":166,"conditions":167,"keywords":170,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":50},"100624539","postpartum-acupressure-education-and-breastfeeding-outcomes-100624539","NCT07410949","Postpartum Acupressure Education and Breastfeeding Outcomes","Effect of Postpartum Acupressure Education on Breastfeeding Outcomes: A 12-Month Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 to 45 years\n* Term singleton birth (≥37 weeks of gestation)\n* ≤48 hours postpartum at the time of enrollment\n* Intention to breastfeed\n* Ability to communicate in Turkish\n* Access to a smartphone for educational materials and follow-up reminders\n* Willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Contraindications to breastfeeding (e.g., infant galactosemia)\n* Severe neonatal condition preventing breastfeeding\n* Severe maternal medical or psychiatric condition interfering with breastfeeding\n* Current opioid, alcohol, or substance dependence\n* Multiple gestation pregnancy\n* Severe breast injury or condition within the first 72 hours postpartum preventing breastfeeding","45 Years",{"count":164,"type":22},360,[62],"This randomized controlled trial evaluates whether acupressure education provided to mothers within the first 48 hours postpartum improves exclusive breastfeeding rates at 6 months compared with standard postpartum care alone. Mothers in the intervention group will receive structured education on self-administered acupressure at selected points and will be encouraged to continue home-based practice, while the control group will receive standard breastfeeding support. Participants will be followed for 12 months to assess breastfeeding continuation, breastfeeding self-efficacy, breastfeeding quality, and breastfeeding-related outcomes.",[32,168,169],"Lactation","Postpartum Period",[171,89,172,173,174],"Acupressure","Exclusive breastfeeding","Breastfeeding continuation","Breastfeeding self-efficacy","2026-05-30",{"date":177,"type":42},"2026-06-02",{"date":179,"type":42},"2026-04-25",{"date":181,"type":22},"2027-02-15",{"name":183,"class":49},"Nigde Omer Halisdemir University",{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":60,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":50},"100621394","effect-of-topical-oxygen-and-led-light-therapy-on-nipple-crack-100621394","NCT07370051","Effect of Topical Oxygen and LED Light Therapy on Nipple Crack","Effect of Topical Oxygen and LED Light Therapy on Nipple Crack: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Individuals aged 18-40,\n* Those who gave birth at term (37-42 weeks),\n* Those whose baby was 0-28 days old at the first visit,\n* Those diagnosed with nipple fissures,\n* Breastfeeding their baby,\n* Those who have had a single birth,\n* Those without a diagnosis of psychiatric illness and who are not taking related medication.\n\nExclusion Criteria:\n\n* Those with infection, mastitis, abscess, etc. accompanying nipple injury,\n* Those who have started medical treatment for nipple injury,\n* Those who are unable to continue breastfeeding,\n* Those who feed their baby by expressing breast milk,\n* Those who show any adverse reaction to photosensitivity or exposure to sunlight.","40 Years",{"count":193,"type":22},51,[62],"The World Health Organization and UNICEF define the protection and support of breastfeeding as one of the key determinants of maternal and newborn health. Nipple cracks are common in the postpartum period and cause breastfeeding problems. If not addressed early, they can lead to interrupted or complete cessation of breastfeeding. It is important to develop methods for effective, safe, and mother-friendly care of nipple cracks. Various care approaches, such as lanolin, natural products, and hydrogels, have been described in the literature. However, evidence for non-invasive agents that support wound healing at the cellular level is limited. Evidence for LED light application is limited, and there is no evidence regarding the effect of topical oxygen application on nipple cracks.\n\nThis project is designed as a randomized controlled trial to investigate the effect of topical oxygen and LED light therapy applied to nipple cracks on wound healing, pain, and breastfeeding success. The study will be conducted at the Lactation Unit of Istanbul Haseki Training and Research Hospital, Ministry of Health, between March and December 2026. The sample size was calculated using the G\\*Power program; with an effect size of 0.20, a significance level of 5%, and a power of 80%, a total of 51 mothers will be included in the study. Participants will be divided into three groups using the block randomization method: Topical Oxygen (n=17), LED Light Therapy (n=17), and Control (n=17). Standard breastfeeding counseling will be provided to all groups. In addition to the intervention groups, topical oxygen will be applied at a flow rate of 10 liters per minute for 20 minutes; LED light therapy will be applied at 630 nm red and 850 nm infrared wavelengths, at an energy dose of 15.3 J\u002Fcm², for 5 minutes. Interventions will be performed on days 0, 3, and 7. Data will be collected using a personal information form, wound size measurement, Nipple Trauma Score, Visual Analog Scale, and LATCH score. The validity and reliability of the Nipple Trauma Score in Turkish will be assessed within the scope of the project.\n\nTo reduce measurement and analysis bias, support will be obtained from an independent observer and a statistician.",[32,197,198,199],"Newborn Infant","Midwifery","Breast","NOT_YET_RECRUITING","2026-05-23",{"date":203,"type":42},"2026-05-27",{"date":205,"type":22},"2026-09-15",{"date":207,"type":22},"2027-04-15",{"name":209,"class":49},"Istanbul University - Cerrahpasa",{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":80,"sex":18,"minAge":19,"maxAge":191,"enrollmentInfo":218,"targetDuration":4,"studyType":60,"phases":220,"briefSummary":221,"conditions":222,"keywords":225,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":50},"100639394","skin-to-skin-contact-and-lavender-aromatherapy-after-elective-cesarean-effects-on-cortisol-and-early-breastfeeding-100639394","NCT07612059","Skin-to-Skin Contact and Lavender Aromatherapy After Elective Cesarean: Effects on Cortisol and Early Breastfeeding","Elective Cesarean Section Postpartum Structured Mother-Infant Skin-to-Skin Contact With Maternal Lavender Aromatherapy: Effects on Maternal Salivary Cortisol, IgA Levels and Early Breastfeeding Outcomes - A Randomized Controlled Trial","LAVENDER-SSC","Inclusion Criteria:\n\n* Female participants aged 18 to 40 years\n* Term singleton pregnancy (≥37 weeks of gestation)\n* Scheduled for elective cesarean section\n* ASA physical status I-II\n* Planned spinal anesthesia\n* Clinically stable mother and newborn immediately after birth\n* Ability to initiate breastfeeding in the early postpartum period\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Emergency cesarean section\n* General anesthesia or conversion from spinal to general anesthesia\n* Need for neonatal resuscitation or severe neonatal compromise\n* Maternal hemodynamic instability or massive hemorrhage\n* Major fetal congenital anomalies\n* Known allergy or intolerance to lavender\n* Severe asthma or intolerance to strong odors\n* Major psychiatric disorders\n* Serious endocrine diseases affecting stress hormone regulation\n* Clinical conditions that preclude breastfeeding\n* Contraindications to spinal anesthesia\n* Refusal to participate in the study",{"count":219,"type":22},150,[62],"This single-center randomized controlled clinical trial will evaluate the effects of structured early postpartum mother-infant skin-to-skin contact, with or without maternal lavender aromatherapy, after elective cesarean section on maternal stress biomarkers and early breastfeeding outcomes. The study will enroll 150 term pregnant women scheduled for elective cesarean section under spinal anesthesia at Ataturk University Research Hospital. Participants will be randomized into three groups: routine postoperative care, structured skin-to-skin contact, and structured skin-to-skin contact combined with inhalational lavender aromatherapy. The primary outcome is the change in maternal salivary cortisol level from immediately after birth to 60 minutes postpartum. Secondary outcomes include maternal salivary IgA levels, state anxiety scores, postoperative pain and nausea, time to first analgesic requirement, early breastfeeding initiation and success, LATCH scores, neonatal axillary temperature, cumulative duration and continuity of skin-to-skin contact, maternal satisfaction, and the need for mother-infant separation within the first 2 hours postpartum.",[32,223,169,224],"Cesarean Section","Maternal Stress",[226,227,228,229,230,231,232],"Elective cesarean section","Skin-to-skin contact","Lavender aromatherapy","Salivary cortisol","Immunoglobulin A (IgA)","Early breastfeeding","Postoperative pain","2026-05-21",{"date":235,"type":42},"2026-05-28",{"date":237,"type":22},"2026-06-01",{"date":239,"type":22},"2027-12-30",{"name":241,"class":49},"Ataturk University",{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":80,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":60,"phases":251,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":4},"100508541","phase-4-effect-of-iodine-containing-multiple-micronutrient-during-lactation-on-infant-neurodevelopment-100508541","NCT05901766","Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment","Effect of Maternal Supplementation With an Iodine-containing Multiple Micronutrient During Lactation on Infant Iodine Status, Thyroid Function and Neurodevelopment","To be eligible, women will be required to meet the following inclusion criteria:\n\n* Maternal age 18 years or above, singleton pregnancy,\n* data available on Last Menstrual Period (LMP) or early ultrasound,\n* Intention to exclusively feed breastmilk for 4 to 6 months,\n* Intention to stay in the study catchment area for at least 6 months,\n* Willingness to take a daily supplement of MMS for 6 months\n\nExclusion criteria include:\n\n* Severe maternal morbidity (postpartum eclampsia, postpartum hemorrhage),\n* Maternal condition leading to inability for infant to directly\u002Fexclusively breastfeed (maternal mastectomy, or other breast surgery),\n* Breast cancer,\n* Tuberculosis",{"count":250,"type":22},600,[252],"PHASE4","The goal of this clinical trial is to learn about the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers who live in settings with mild iodine deficiency.\n\nThe main questions it aims to answer are:\n\n1. What are the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers on infant development, as measured by electroencephalography\u002Fvisual evoked potentials?\n2. What are the effects of iodine-containing multiple micronutrient supplements on breast milk concentrations of iodine, and infant iodine and thyroid status?\n3. How do iodine and iron interact with each other to affect thyroid function in the mother during lactation?\n\nParticipants will be randomized to receive a daily multiple micronutrient tablet containing iodine (UNIMAPP) for 6 months postpartum, or routine postnatal care per Ethiopia Ministry of Health. Mothers will provide a breast milk sample and blood at 3 and 6 months postpartum. Infants will provide a urine sample and drop of blood, and have a neurodevelopmental assessment at 3 and 6 months.\n\nResearchers will compare the groups that received the iodine-containing micronutrient supplement with the group that received routine care and see if there were any benefits on infant development and iodine and thyroid status in the mother and baby.",[255,256,257,32],"Iodine Deficiency","Nutrition Poor","Development, Infant",{"date":259,"type":42},"2026-05-26",{"date":261,"type":22},"2026-05-01",{"date":263,"type":22},"2028-03-31",{"name":265,"class":49},"Brown University",{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":18,"minAge":274,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":60,"phases":277,"briefSummary":278,"conditions":279,"keywords":296,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":308,"leadSponsor":310,"locationsCount":50},"100636706","improved-child-nutrition-and-development-through-social-transfers-100636706","NCT07569172","Improved Child Nutrition and Development Through Social Transfers","Taabo Enhanced Nutrition and Development Through Economic Rewards","TENDER","Inclusion Criteria:\n\n1. Are enrolled in the Taabo multigenerational birth cohort (MGC)\n2. Completed the postpartum interview of the Taabo MGC\n3. Have a child who is within two weeks of their 12-month birthday,\n4. are breastfeeding at time of recruitment,\n5. live in the Taabo HDSS, Côte d'Ivoire\n6. have no illnesses that contraindicates breastfeeding,\n7. had a healthy singleton infant with a birth weight of at least 2500 grams, and\n8. agree to participate and sign an informed consent; if underage (12-17 years), a legal representative will also have to agree to sign the informed consent\n\nExclusion Criteria:\n\n1. Plans to move permanently outside study area\n2. Has a medical, intellectual or psychological disability\n3. Contraindication for breastfeeding\n4. Children born with \\\u003C 2500 grams","12 Years",{"count":276,"type":22},1040,[62],"The goal of this clinical trial is to learn if a conditional social transfer works to improve rates of complementary breastfeeding. It will also learn about the impacts of social transfers on maternal and child health and development. The main questions it aims to answer are:\n\n* Does the social transfer increase complementary breastfeeding rates at 24-months postpartum?\n* Does the social transfer increase complementary breastfeeding duration?\n* Does the social transfer impact child health and development?\n* Does the social transfer impact maternal physical and mental health?\n\nResearchers will compare a conditional social transfer to a control group that only receives education about breastfeeding recommendations to see if a conditional social transfers works to increase complementary breastfeeding.\n\nParticipants will:\n\nReceive a pamphlet explaining the current recommendations of breastfeeding Receive instructions that if they meet the recommendation to breastfeed until 24-months postpartum they receive a social transfer or receive no additional information Complete home visits at 12- and 24-months postpartum Complete detailed questionnaire",[32,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295],"Breastfeeding Education","Breastfeeding Duration","Breastfeeding Continuation","Child Growth","Stress","Infectious Diseases","Anemia","Child Development","Weight Loss","Blood Pressure","Mental Health","Diarrhea","Coughing","Eczema","Allergies","Antibiotic Use",[144,297,298,299,300,301,302,303],"cash transfer","child health","maternal health","mental health","child growth","child development","education","2026-04-28",{"date":306,"type":42},"2026-05-06",{"date":237,"type":22},{"date":309,"type":22},"2028-02-28",{"name":311,"class":49},"Swiss Tropical & Public Health Institute",{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":80,"sex":18,"minAge":320,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":60,"phases":323,"briefSummary":324,"conditions":325,"keywords":327,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":337,"leadSponsor":339,"locationsCount":4},"100626417","breath-based-yoga-supported-breastfeeding-education-in-primiparous-mothers-100626417","NCT07435363","Breath-Based Yoga-Supported Breastfeeding Education in Primiparous Mothers","Effects of Breath-Based Yoga Supported Breastfeeding Education on Anxiety, Breastfeeding Self-Efficacy, and Perceived Insufficient Milk Supply in Primiparous Mothers: A Randomized Controlled Trial","BYBSE","Inclusion Criteria:\n\nInclusion Criteria for Intervention and Control Groups\n\n* Primiparous mothers aged 19 years or older who delivered at term (37-42 weeks),\n* Mothers who gave birth in a Baby-Friendly Hospital in Sakarya,\n* Mothers who are open to communication and cooperation, voluntarily agree to participate in the study, and had a normal vaginal delivery,\n* Mothers who agree to participate in the study during postpartum weeks 0-2 and who will be in postpartum weeks 2-10 during the intervention period,\n* Mothers who breastfeed or practice mixed feeding,\n* Mothers and infants who are in good health,\n* Mothers with a Body Mass Index within the normal range,\n* Mothers without sensory impairments such as hearing or vision problems,\n* Mothers without a diagnosed psychiatric history,\n* Mothers who can read and write in Turkish,\n* Mothers who score below 13 on the Edinburgh Postpartum Depression Scale (EPDS) at the first assessment.\n\nExclusion Criteria for Intervention and Control Groups\n\n* Infant loss,\n* Mothers with visual, auditory, or cognitive impairments,\n* Infants with physical disabilities or congenital anomalies,\n* Mothers with any neurological, orthopedic, or chronic condition that may prevent participation in exercise,\n* Mothers scoring 13 or above on the Edinburgh Postnatal Depression Scale (EPDS) at the first assessment,\n* Mothers who practiced yoga or breathing exercises during pregnancy or postpartum will be excluded,\n* Since brief educational sessions provided before discharge in Baby-Friendly Hospitals are routine in Turkey, they will not be considered exclusion criteria.\n* However, mothers who received a structured breastfeeding education program during pregnancy or postpartum will be excluded from the study.\n\nWithdrawal Criteria for Intervention and Control Groups\n\n* Participants who request to withdraw from the study at any time,\n* Participants who miss more than two yoga-breathing sessions, more than two breastfeeding education sessions, or who cannot be reached will be removed from the study.","19 Years",{"count":322,"type":22},90,[62],"This study is designed as a randomized controlled trial (RCT) focused on improving breastfeeding outcomes among primiparous mothers in the postpartum period. Although the World Health Organization (WHO) recommends exclusive breastfeeding for the first six months as the ideal nutritional source for newborns, the rate in Turkey (41% according to TDHS 2018) lags behind global targets (50-70%). Early cessation of breastfeeding is generally associated with mothers' inability to adapt to physical and psychological challenges. In particular, anxiety and stress experienced during the postpartum period lead to the development of a perceived insufficient milk supply, which negatively affects the acquisition of breastfeeding self-efficacy. In this context, this study investigates the potential of a supportive intervention facilitating stress management and relaxation on breastfeeding sustainability. Participants will be randomized into three groups: Intervention Group I (Online Breastfeeding Education + Breath-Based Yoga), Intervention Group II (Online Breastfeeding Education Only), and the Control Group (Routine Care). The interventions will be delivered remotely via Google Meet over a maximum period of seven weeks (3 weeks of breastfeeding education + 4 weeks of yoga practice). The primary objective of the study is to evaluate whether these structured interventions significantly improve maternal breastfeeding self-efficacy and reduce the perception of insufficient milk. Additionally, secondary outcomes will assess the impact on maternal anxiety levels. To ensure internal validity and isolate the intervention effect, mothers at high risk of postpartum depression (EPDS score \\> 13) are excluded from the study.\n\nThe Hypotheses of the Study\n\nEach hypothesis will be tested independently:\n\nH₀: The pre- and post-intervention measurement differences do not significantly differ between groups.\n\nH₁: The pre- and post-intervention measurement differences significantly differ between groups (p \\\u003C 0.05).\n\nIf a significant difference is detected, H₀ will be rejected and H₁ will be accepted. Multiple comparisons will be evaluated using the Holm-Bonferroni correction to control the Type I error rate.\n\n* H1a: Online breastfeeding education provided to primiparous mothers positively affects their anxiety levels.\n* H1b: Online breastfeeding education provided to primiparous mothers positively affects their breastfeeding self-efficacy.\n* H1c: Online breastfeeding education provided to primiparous mothers positively affects their perceived insufficient milk supply.\n* H2a: Breath-based yoga-supported online breastfeeding education provided to primiparous mothers positively affects their anxiety levels.\n* H2b: Breath-based yoga-supported online breastfeeding education provided to primiparous mothers positively affects their breastfeeding self-efficacy.\n* H2c: Breath-based yoga-supported online breastfeeding education provided to primiparous mothers positively affects their perceived insufficient milk supply.",[32,326],"Perceived Insufficient Milk Supply",[144,328,329,330,331,332,333],"breastfeeding education","breastfeeding self-efficacy","perceived insufficient milk supply","yoga","breath-based yoga","primiparous mothers","2026-04-22",{"date":304,"type":42},{"date":237,"type":22},{"date":338,"type":22},"2027-06-01",{"name":340,"class":49},"Sakarya University",{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":80,"sex":348,"minAge":349,"maxAge":320,"enrollmentInfo":350,"targetDuration":4,"studyType":60,"phases":352,"briefSummary":353,"conditions":354,"keywords":359,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":371,"locationsCount":50},"100634533","effect-of-mbsr-training-on-childbirth-fear-bonding-and-breastfeeding-in-adolescent-pregnant-women-100634533","NCT07540923","Effect of MBSR Training on Childbirth Fear, Bonding and Breastfeeding in Adolescent Pregnant Women","Effect of Mindfulness-Based Stress Reduction Training on Fear of Childbirth, Maternal and Paternal Bonding and Breastfeeding Success in Adolescent Pregnant Women and Their Partners","Inclusion Criteria:\n\n1. Being between 15-19 years of age\n2. Being in the third trimester of pregnancy (30-33 weeks of gestation)\n3. Being primiparous\n4. Having no history of miscarriage, abortion or similar obstetric problems during pregnancy\n5. Not having a high-risk pregnancy diagnosis\n6. Being literate\n7. Partner accepting to actively participate in the parenting process\n\nExclusion Criteria:\n\n1. Having a chronic disease\n2. Having physical or psychological health problems\n3. Having a psychiatric diagnosis in the participant or their partner\n4. Having a detected health problem or congenital anomaly in the fetus\n5. Having previously received Mindfulness-Based Stress Reduction (MBSR) training\n6. Not completing the planned training program\n7. Voluntarily withdrawing from the study","ALL","15 Years",{"count":351,"type":22},54,[62],"This randomized controlled study aims to evaluate the effect of Mindfulness-Based Stress Reduction (MBSR) training given to adolescent pregnant women and their partners on fear of childbirth, maternal and paternal bonding, and breastfeeding success. Adolescent pregnancy is associated with increased stress, fear of childbirth and parenting anxiety, which negatively affect mother-infant and father-infant bonding and breastfeeding outcomes. MBSR training is expected to reduce fear of childbirth, strengthen maternal and paternal bonding, and improve breastfeeding success in adolescent pregnant women and their partners compared to the control group receiving routine care.",[355,356,357,358,32],"Pregnancy in Adolescence","Fear","Mother-Child Relations","Mindfulness",[360,361,362,363,364,32],"Adolescent Pregnancy","Fear of Childbirth","Maternal Bonding","Paternal Bonding","Mindfulness-Based Stress Reduction","2026-04-17",{"date":367,"type":42},"2026-04-21",{"date":369,"type":42},"2025-12-01",{"date":175,"type":22},{"name":372,"class":49},"Inonu University",{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":162,"enrollmentInfo":381,"targetDuration":4,"studyType":60,"phases":383,"briefSummary":384,"conditions":385,"keywords":387,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":396,"leadSponsor":398,"locationsCount":50},"100633226","midwife-led-digital-follow-up-after-cesarean-section-100633226","NCT07523932","Midwife-Led Digital Follow-Up After Cesarean Section","The Effect of a Midwife-Led Digital Follow-Up Program on Postpartum Depression, Perceived Social Support, and Breastfeeding Self-Efficacy in Women After Cesarean Section: A Randomized Controlled Trial","MID-CS","Inclusion Criteria:\n\n* Women aged between 18 and 45 years\n* Women who have undergone cesarean section\n* Within the first 24 hours postpartum\n* Able to communicate in Turkish\n* Having a healthy singleton newborn\n* Willing to participate and provide informed consent\n\nExclusion Criteria:\n\n* History of psychiatric disorders\n* Presence of severe maternal complications\n* Newborn requiring intensive care unit admission\n* Women with communication difficulties\n* Participation in another intervention study",{"count":382,"type":22},104,[62],"This randomized controlled trial aims to evaluate the effect of a midwife-led digital follow-up program on postpartum depression, perceived social support, and breastfeeding self-efficacy in women who will undergo cesarean section.\n\nParticipants will be randomly assigned to either an intervention group that will receive structured face-to-face education followed by a 4-week digital follow-up program, or a control group that will receive routine postpartum care.\n\nData will be collected at baseline (postpartum day 1), at 1 week, and at 4 weeks postpartum using validated measurement tools.\n\nThe study will provide evidence on the effectiveness of continuous, midwife-led digital support in improving maternal psychological well-being and breastfeeding outcomes in the early postpartum period.",[386,32,169],"Postpartum Depression",[223,388,389,390,391,139],"Midwife-Led Intervention","Digital Follow-Up","Breastfeeding Self-Efficacy","Social Support","2026-04-13",{"date":394,"type":42},"2026-04-16",{"date":122,"type":22},{"date":397,"type":22},"2026-10",{"name":372,"class":49},{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":132,"enrollmentInfo":407,"targetDuration":4,"studyType":60,"phases":409,"briefSummary":410,"conditions":411,"keywords":415,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":427},"100459897","mhealth-india-postnatal-health-intervention-effectiveness-100459897","NCT05268588","mHealth India Postnatal Health Intervention Effectiveness","Effectiveness of an mHealth Interactive Education and Social Support Intervention for Improving Postnatal Health","Kushal Maa","Inclusion Criteria:\n\n* Pregnant (28-32 weeks gestational age)\n* Speak local language\n* Personal mobile phone or willing to accept study phone\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Do not speak local language\n* No personal phone or unwilling to accept study phone\n* Unable to provide informed consent",{"count":408,"type":22},2100,[62],"The goal of this study is to assess the effectiveness of a culturally-tailored mobile interactive education and support group intervention to supplement standard postpartum care activities in comparison to standard care alone on health-related behaviors and health outcomes in a randomized controlled trial among 2100 postpartum Indian women living in 3 geographically diverse Indian states to estimate the impact on maternal and neonatal health-related knowledge, health-related behaviors, and health outcomes. The investigators also seek to characterize mechanisms of impact including knowledge, social support, self-efficacy, and behavior change, and determine the cost-effectiveness.",[412,413,32,414],"Health Knowledge, Attitudes, Practice","Post Partum Depression","Nutrition, Healthy",[416,417],"mHealth","group care","2026-03-31",{"date":420,"type":42},"2026-04-01",{"date":422,"type":42},"2025-01-20",{"date":424,"type":22},"2027-05-31",{"name":426,"class":49},"University of California, San Francisco",3,{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":80,"sex":18,"minAge":19,"maxAge":162,"enrollmentInfo":435,"targetDuration":4,"studyType":60,"phases":437,"briefSummary":438,"conditions":439,"keywords":451,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":50},"100632191","effects-of-breastfeeding-virtual-reality-and-stress-ball-on-pain-anxiety-cortisol-levels-and-comfort-during-episiotomy-repair-100632191","NCT07510477","Effects of Breastfeeding, Virtual Reality, and Stress Ball on Pain, Anxiety, Cortisol Levels, and Comfort During Episiotomy Repair","Effects of Breastfeeding, Virtual Reality, and Stress Ball on Pain, Anxiety, Cortisol Levels, and Comfort During Episiotomy Repair in Primiparous Women: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Pregnant women between 18 and 45 years of age.\n* Primiparous women (first-time mothers).\n* Gestational age between 37 and 42 weeks (term pregnancy).\n* Singleton pregnancy with a vertex presentation.\n* Spontaneous vaginal delivery requiring a mediolateral episiotomy.\n* Newborn birth weight between 2500 and 4500 grams.\n* Newborn Apgar scores of 7 or higher at the 1st and 5th minutes.\n* Ability to read, understand, and speak Turkish fluently.\n* Voluntary participation with signed informed consent.\n\nExclusion and Withdrawal Criteria:\n\n* Requesting to withdraw from the research at any stage.\n* Presence of any congenital anomalies in the newborn.\n* Presence of maternal visual or hearing impairments.\n* Occurrence of fetal mortality or morbidity.\n* Occurrence of anal sphincter injury or 3rd\u002F4th-degree lacerations in addition to the episiotomy.\n* Performance of the episiotomy repair in an operating room.\n* Use of assisted delivery methods (e.g., vacuum extraction).\n* Administration of sedative drugs or extra anesthetic agents (excluding routine local perineal infiltration).\n* Development of maternal complications (e.g., postpartum hemorrhage) preventing data collection.",{"count":436,"type":22},120,[62],"The goal of this clinical trial is to learn about the effects of three different interventions-breastfeeding, using a stress ball, or wearing virtual reality (VR) goggles-on pain, anxiety, and stress during episiotomy repair (stitching) after childbirth. It also aims to examine how these methods affect a mother's comfort after the procedure.\n\nThe main questions it aims to answer are:\n\nDoes breastfeeding, using a stress ball, or using VR goggles lower the mother's pain and anxiety during the repair? Do these interventions reduce the mother's biological stress levels, measured by saliva cortisol tests? Do these methods lead to higher postpartum comfort levels for the mother in the first 24 hours after birth?\n\nResearcher will compare these three intervention groups to a \"control group\" (mothers receiving standard hospital care) to see which approach is most effective.\n\nParticipants will:\n\nBe randomly assigned to one of four groups: Breastfeeding, VR Goggles, Stress Ball, or Standard Care.\n\nUse their assigned intervention throughout the entire episiotomy repair process.\n\nProvide saliva samples before and after the procedure to measure stress hormones (cortisol).\n\nRate their pain and anxiety levels using clinical scales twice: once before the procedure begins and once immediately after it is finished.\n\nComplete a survey about their comfort levels between 6 and 24 hours after the delivery.",[440,32,441,442,443,444,445,446,447,448,449,450,198],"Episiotomy","Virtual Reality","Virtual Goggles","Anxiety","Cortisol","Postpartum Comfort","Postpartum Comfort Scale","Stress Physiological","PAIN, ANXIETY, AND COMFORT","Acute Pain","Stress Ball",[32,441,450,452,453,454,455,440,456],"Midwifery Care","Primiparous Women","Randomized Controlled Trial","Salivary Cortisol","Episiotomy Repair","2026-03-30",{"date":459,"type":42},"2026-04-03",{"date":461,"type":22},"2026-04",{"date":463,"type":22},"2027-09",{"name":465,"class":49},"Aydin Adnan Menderes University",{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":470,"acronym":471,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":473,"enrollmentInfo":474,"targetDuration":4,"studyType":60,"phases":476,"briefSummary":479,"conditions":480,"keywords":481,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":503},"100632071","phase-1-effects-of-5-methyltetrahydrofolic-acid-supplementation-on-maternal-health-and-one-carbon-metabolism-during-lactation-100632071","NCT07508917","Effects of 5-Methyltetrahydrofolic Acid Supplementation on Maternal Health and One-Carbon Metabolism During Lactation","OCMS","Inclusion Criteria:\n\n* Maternal age between 18 and 42 years\n* Gestational age at birth ≥ 37 weeks.\n* Exclusive breastfeeding at enrollment.\n* Infant age 0-1 months\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Presence of disease or malformations in the infant.\n* Weight-Standard Deviation Score \\\u003C -1 at enrollment.\n* Use of folate-containing multivitamin supplements during breastfeeding","42 Years",{"count":475,"type":22},36,[477,478],"PHASE1","PHASE2","This double-blind, randomized, placebo-controlled parallel trial evaluates the effects of maternal 5-methyltetrahydrofolate (5-MTHF) supplementation during breastfeeding. Thirty-six lactating mother-infant dyads will be randomized (1:1) to receive 5-MTHF or placebo for 6 weeks, stratified by infant sex and mode of delivery. Tolerability and adverse events will be monitored.\n\nPre- and post-intervention assessments include breast milk one-carbon metabolites and oligosaccharides; maternal plasma one-carbon metabolites and metabolic health markers. Maternal mental health will be evaluated using the SCL-90-R questionnaire. A follow-up visit at 4 months will reassess infant anthropometry and microbiome outcomes.",[32],[482,483,484,485,486,487,488,489,490,491,492,493],"5-Methyltetrahydrofolate (5-MTHF)","One-carbon metabolism","Human milk oligosaccharides","Breast milk composition","Betaine","Early-life nutrition","Maternal supplementation","Maternal mental health","5-MTHF","Gut Microbiome","Metabolomics","Infant Microbiota","2026-03-27",{"date":496,"type":42},"2026-04-02",{"date":498,"type":22},"2026-04-15",{"date":500,"type":22},"2027-02-28",{"name":502,"class":49},"Fundació Sant Joan de Déu",2,{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":80,"sex":348,"minAge":4,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":526},"100615511","understanding-practices-of-lactation-and-infant-feeding-together-with-women-with-hiv-in-the-united-states-100615511","NCT07293559","Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States","UPLIFT","Core Activity 1 Inclusion Criteria: Pregnant and Postpartum Women with HIV\n\n* Is of legal age or circumstance to provide independent informed consent\n* Belongs to one of the following five categories:\n\n  * Is pregnant with a gestational age of 28 0\u002F7 to 37 6\u002F7 weeks at entry and is considering breastfeeding\n  * Is pregnant with a gestational age of 28 0\u002F7 to 37 6\u002F7 weeks at entry and is not considering breastfeeding\n  * Gave birth to a live born infant after 28 February 2023, is over 4 weeks postpartum, did not breastfeed for any duration and has no intent to breastfeed\n  * Gave birth to a live born infant after 28 February 2023, is over 4 weeks postpartum, breastfed for less than four weeks, and has weaned\n  * Gave birth to a live born infant after 28 February 2023, is over 4 weeks postpartum, and breastfed for four weeks or longer\n* Diagnosed with HIV prior to or during the pregnancy\n* If preferred language is other than English, is willing to participate in interviews with an available translator.\n\nCore Activity 1 Inclusion Criteria: Healthcare Providers and Ancillary Healthcare Professionals\n\n* Is of legal age or circumstance to provide independent informed consent\n* Is a healthcare provider who self-identifies as an obstetrician, midwife, nurse, adult or pediatric infectious disease specialist, or advance practice provider who participated in the care of at least five PPWH and\u002For their infants over the three years prior to entry OR\n* Is an ancillary healthcare professional who self-identifies as a social worker, lactation support provider, patient navigator, pharmacist, doula who participated in the care of at least five PPWH and\u002For their infants over the three years prior to entry\n\nCore Activity 1 Inclusion Criteria: Influential Individuals\n\n* Has been identified by a PPWH enrolled in Core Activity 1 as aware of her HIV status and contributing to her infant feeding decisions\n* Is of legal age or circumstance to provide independent informed consent\n* If preferred language is other than English, is willing to participate in interviews with an available translator.\n\nCore Activity 2 Inclusion Criteria: Pregnant and Postpartum Women with HIV and their Infant\n\n* Is of legal age or circumstance to provide independent informed consent\n* Is pregnant with singleton fetus with a gestational age of ≥ 28 0\u002F7 weeks at entry OR\n* Gave birth to a live born, singleton infant up to 7 days prior to entry\n* Diagnosed with HIV prior to or during the pregnancy\n* Expected to be available for the duration of follow-up\n\nCore Activity 3 Inclusion Criteria: Breastfeeding Postpartum Women with HIV and their Infant\n\n* Is of legal age or circumstance to provide independent informed consent\n* Must be up to 7 days postpartum with live-born infant\n* Diagnosed with HIV prior to or during the pregnancy\n* Breastfed her infant for any duration\n\nCore Activity 3 Inclusion Criteria: Pilot Registry Testers\n\n* Is of legal age or circumstance to provide independent informed consent\n* Working at a healthcare facility that provides care for women with HIV who are breastfeeding and\u002For their infants\n\nExclusion Criteria: Core Activities 1-3\n\n* Has any condition identified during the screening period that, in the opinion of site investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives",{"count":512,"type":22},1150,"IMPAACT 2046\u002FUPLIFT (Understanding Practices of Lactation and Infant Feeding decisions Together with women with HIV) is a multi-site, mixed-methods, observational cohort study. The purpose of the study is to explore infant feeding preferences, practices, and outcomes among mothers with HIV and their families in the United States. It will employ both qualitative and quantitative research methods to address existing knowledge gaps and to understand the clinical, behavioral, and social factors influencing infant feeding decisions. As part of the study's mixed method approach, a longitudinal cohort study of mothers and their infants will be established. The study also aims to pilot a national registry of breastfeeding women living with HIV in the United States.",[515,32,516],"HIV-1-infection","Pregnancy Related","2026-03-25",{"date":494,"type":42},{"date":520,"type":42},"2026-02-24",{"date":522,"type":22},"2031-04-24",{"name":524,"class":525},"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","NETWORK",11,{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":533,"eligibilityCriteria":534,"healthyVolunteers":80,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":537,"conditions":538,"keywords":542,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":548,"completionDateStruct":549,"leadSponsor":551,"locationsCount":50},"100631345","peer-support-breastfeeding-program-for-mothers-in-severe-socioeconomic-deprivation-feasibility-study-100631345","NCT07499466","Peer-Support Breastfeeding Program for Mothers in Severe Socioeconomic Deprivation: Feasibility Study","Feasibility Study of a Peer-Support Breastfeeding Resource and Support Program for Mothers Experiencing Severe Socioeconomic Deprivation","PARTAGE","Inclusion Criteria:\n\n* Mother with at least one infant hospitalized in the maternity or neonatal unit at the Hôpital Femme Mère Enfant (HFME)\n* Who Intents to breastfeed\n* Who is in a severe socioeconomic deprivation\n* Having sufficient proficiency in French or in one of the languages spoken by the available peer supporters to allow communication\n* Aged 18 years or older\n* Given verbal consent to participate in the study\n\nExclusion Criteria:\n\n* \\- Having a medical contraindication to breastfeeding\n* Having an infant with a known congenital condition with life-threatening prognosis\n* Having a severe psychiatric condition considered incompatible with participation in the peer-support intervention\n* Being under legal guardianship",{"count":536,"type":22},50,"Breastfeeding provides well-established and \"irreplaceable\" health benefits for both mothers and infants. However, breastfeeding rates in France remain among the lowest in Europe and are strongly associated with socioeconomic status. Mothers experiencing severe socioeconomic deprivation, including those facing housing instability or migration-related challenges, may encounter additional barriers to breastfeeding, such as social isolation, limited access to health information, and linguistic or cultural obstacles.\n\nPeer and community support have been shown to positively influence breastfeeding initiation and continuation. The Relais Allaitement Program (PRALL) is a peer-support program designed to promote breastfeeding and support early parenting through trained volunteer mothers. The PARTAGE project aims to adapt and pilot the PRALL program for mothers experiencing severe socioeconomic deprivation receiving care at the maternity unit of the Hôpital Femme Mère Enfant (HFME), in Bron, France.\n\nThis prospective, interventional, non-comparative feasibility study will evaluate the acceptability and feasibility of a peer-support breastfeeding program delivered by trained experienced mothers (peer supporters).\n\nThe intervention includes:\n\n* the adaptation of PRALL educational materials and training to the needs of vulnerable populations using participatory approaches and accessible communication principles,\n* the recruitment and training of two nursery nurses from the maternity unit to become network coordinators of the peer-support network,\n* the recruitment of experienced mothers who will be trained by the 2 network coordinators, to become breastfeeding peer supporters,\n* and the implementation of breastfeeding support by peer supporters for eligible mothers.\n\nEligible mothers experiencing severe socioeconomic deprivation will be offered support from a trained peer supporter during the postpartum period.\n\nThe primary outcome is the number of completed support interventions, defined as to have at least two in-person mother\u002Fpeer supporter contacts and to last at least one month, unless breastfeeding cessation or infant death occurs earlier. Qualitative interviews with participating mothers and peer supporters will also be conducted to explore barriers and facilitators to breastfeeding support in this population.\n\nThe results will inform the adaptation of the PRALL program for vulnerable populations and assess the feasibility of implementing a peer-support breastfeeding intervention in this context. Findings may guide the development of a larger multicenter study to evaluate the impact of peer-support programs on breastfeeding outcomes among socially disadvantaged populations in France and potentially across Europe.",[32,539,540,541],"Breastfeeding Support","Health Disparities","Health Inequalities",[543,544,545],"Peer support","Breastfeeding promotion","Socially deprived mothers","2026-03-24",{"date":457,"type":42},{"date":369,"type":42},{"date":550,"type":22},"2027-12-01",{"name":552,"class":49},"Hospices Civils de Lyon",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":80,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":561,"conditions":562,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":50},"100624711","relationship-between-the-severity-of-sleep-deprivation-in-the-first-48-hours-postpartum-breastfeeding-motivation-and-breastfeeding-success-100624711","NCT07413185","Relationship Between the Severity of Sleep Deprivation in the First 48 Hours Postpartum, Breastfeeding Motivation, and Breastfeeding Success","Inclusion Criteria:\n\n* Primiparous or multiparous women aged 18 years and older\n* Having a healthy term delivery\n* Infant not admitted to the neonatal intensive care unit (NICU)\n* Initiated breastfeeding within the first 48 hours postpartum\n\nExclusion Criteria:\n\n* Complications requiring sedation\n* Severe postpartum hemorrhage\n* Severe postoperative pain or need for narcotic analgesics",{"count":560,"type":22},167,"The postpartum period is a critical time marked by significant physiological and psychosocial changes that can affect sleep, emotional well-being, and breastfeeding behaviors. Previous studies indicate that mode of delivery and sleep quality are closely associated with breastfeeding outcomes, with cesarean birth often linked to poorer sleep and lower breastfeeding success. Evidence also suggests that postpartum sleep disturbances are related to reduced breastfeeding self-efficacy, lower motivation, fatigue, depressive symptoms, and shorter breastfeeding duration.\n\nHowever, the literature lacks studies that evaluate insomnia severity, breastfeeding motivation, and breastfeeding success simultaneously-particularly during the first 48 hours after birth. This analytical study aims to assess insomnia severity, breastfeeding motivation, and breastfeeding success (LATCH) within the first 48 postpartum hours and to examine the relationships among these variables. Findings are expected to support early postpartum clinical interventions to improve maternal and infant health outcomes.",[169,563,32,564,223,168],"Sleep","Motivation","2026-03-23",{"date":546,"type":42},{"date":568,"type":42},"2026-03-12",{"date":570,"type":22},"2027-02-23",{"name":572,"class":49},"Acibadem University",{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":348,"minAge":4,"maxAge":581,"enrollmentInfo":582,"targetDuration":4,"studyType":60,"phases":584,"briefSummary":585,"conditions":586,"keywords":588,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":50},"100567820","pumping-to-up-maternal-milk-production-for-preterms-100567820","NCT06673160","Pumping to Up Maternal Milk Production for Preterms","Pumping to Up Maternal Milk Production for Preterms (PUMMPP)","PUMMPP","Inclusion Criteria:\n\n* Inborn infants \\\u003C32 weeks gestation\n* Out-born infants transferred to our facility \\\u003C48hours of life\n* Infants \\\u003C1500 grams at birth\n* Infants whose parents\u002F guardians have provided legal consent for study participation\n\nExclusion Criteria:\n\n* Infants with birthing persons' that are severe\u002Fcritically ill\n* Birthing persons of infants \\\u003C18 years old\n* Infants with terminal illness or decision to withhold or limit support\n* infants with major congenital anomalies, chromosomal disorders, or congenital infections","28 Days",{"count":583,"type":22},70,[62],"The goal of this clinical trial is to learn about the effect of breast-pumping frequency on breast milk supply\u002F volume in mothers of preterm infants. The main question it aims to answer is:\n\n\\- What effect does pumping frequency have on breast milk supply.\n\nResearchers will compare breastmilk supply of mothers who pump every 2 hours to the supply of those who pump every 3 hours to see if there is a difference in the amount of breastmilk they produce.\n\nParticipants will be assigned to either pump every 2 hours or every 3 hours and record how many milliliters of breastmilk they produce daily for the first 28 days of their baby's life.",[32,587],"Breastmilk Expression",[589,590],"breastmilk supply in preterm infant","breastfeeding preterm infants","2026-03-18",{"date":565,"type":42},{"date":594,"type":42},"2025-06-11",{"date":596,"type":22},"2026-12",{"name":598,"class":49},"University of Alabama at Birmingham",{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":605,"eligibilityCriteria":606,"healthyVolunteers":80,"sex":18,"minAge":19,"maxAge":162,"enrollmentInfo":607,"targetDuration":4,"studyType":60,"phases":609,"briefSummary":610,"conditions":611,"keywords":616,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":620,"completionDateStruct":621,"leadSponsor":623,"locationsCount":503},"100628903","postnatal-exercise-to-activate-babys-brown-fat-100628903","NCT07467694","Postnatal Exercise to Activate Baby's Brown Fat","Impact of Acute Exercise and Habitual Physical Activity on Human Milk Composition and Childhood Obesity Risk","PEABaBy","Inclusion Criteria:\n\n* 18-45 y of age at the time of enrollment\n* Pre-gravid or first trimester BMI 18.5 -40 kg\u002Fm2\n* Uncomplicated singleton pregnancy\n* Intention to exclusively breastfeed for \\>3 months and, if parity \\>1, that they successfully breastfed a previous pregnancy\n* Term pregnancy (gestational age 37 to \\\u003C42 weeks)\n* Infant with birth weight \\>10th percentile of weight for gestational age\n\nExclusion Criteria:\n\n* Any obstetric contra-indication to exercise at 1 month\n* Diagnosis of uncontrolled (HbA1c \\>7%) type 1 or type 2 diabetes, or gestational diabetes managed with insulin\n* Intrauterine growth restriction\n* Pre-eclampsia or other pregnancy complications\n* Alcohol, cannabis or tobacco use\n* Known congenital metabolic, endocrine disease, or congenital illness affecting infant feeding\u002Fgrowth\n* Major fetal anomalies\n* Musculoskeletal issues that would make exercise difficult",{"count":608,"type":22},200,[62],"The purpose of this study is to learn how exercise and physical activity during pregnancy and after pregnancy may affect the composition of breastmilk. Certain changes in breast milk after exercise may have an impact on how infants use energy. Understanding this process may improve public health recommendations for exercise during and after pregnancy. This study can help investigators learn more about how maternal exercise patterns may affect body growth and obesity risk in infants who are breastfed. This research may help identify how different factors can influence healthy weight and early development in infants.",[612,613,614,168,32,88,615],"Childhood Obesity Prevention","Childhood Obesity","Physical Activity","Exercise",[168,32,617,88,615],"Breast milk","2026-03-11",{"date":568,"type":42},{"date":369,"type":42},{"date":622,"type":22},"2030-07-01",{"name":624,"class":49},"Joslin Diabetes Center",{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":631,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":633,"enrollmentInfo":634,"targetDuration":4,"studyType":60,"phases":636,"briefSummary":637,"conditions":638,"keywords":641,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":651,"locationsCount":50},"100620187","effect-of-oketani-breast-massage-on-promoting-breastfeeding-100620187","NCT07354360","Effect of Oketani Breast Massage on Promoting Breastfeeding","Effect of Oketani Massage on Successful Breastfeeding","OKETANI-BF","inclusion criteria:\n\n1. Age between 18 and 35 years\n2. Singleton pregnancy\n3. Term gestation (\\>37-40 weeks).\n4. Women willing to breast feed\n5. The woman will deliver by cesarean section and has relative with her\n6. Absence of maternal physical and\u002F or mental illness that prevents breastfeeding.\n\nThe exclusion criteria include:\n\n1. Women with breast problems such as breast tumors, breast surgery and nipple problems\n2. Women have obstetric complications as postpartum hemorrhage.\n3. Neonatal problems","35 Years",{"count":635,"type":22},100,[62],"Breastfeeding is essential for infant survival and maternal health; however, many primipara women experience breastfeeding difficulties in the early postpartum period, particularly, latching difficulties, ineffective milk transfer, low breastfeeding self-efficacy and breast engorgement, which may compromise successful breastfeeding. Oketani massage is a non-pharmacological, cost-effective breast massage technique developed to enhance milk flow, improve maternal comfort during breastfeeding and reduce breast engorgement. This study aims to evaluate effect of Oketani massage on successful breastfeeding. Successful breastfeeding will be assessed through indicators of maternal latching technique, successful breastfeeding behavior and maternal breastfeeding self-efficacy. The findings of this study may support the use of Oketani massage as a supportive nursing intervention to promote successful breastfeeding outcomes in the early postpartum period",[32,390,639,640],"Oketani Massage","Latching",[32,642,329,643,644],"Oketani massage","breast engorgement","Feeding Behavior","2026-03-07",{"date":647,"type":42},"2026-03-10",{"date":649,"type":22},"2026-02",{"date":596,"type":22},{"name":652,"class":49},"Mansoura University",{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":4,"eligibilityCriteria":659,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":660,"enrollmentInfo":661,"targetDuration":4,"studyType":60,"phases":662,"briefSummary":663,"conditions":664,"keywords":667,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":676,"completionDateStruct":678,"leadSponsor":680,"locationsCount":50},"100474443","phase-4-postpartum-vaginal-estrogen-for-breastfeeding-patients-100474443","NCT05457972","Postpartum Vaginal Estrogen for Breastfeeding Patients","Postpartum Vaginal Estrogen for Sexual Function in Breastfeeding Patients: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 or older\n* Sexually active\n* Singleton, term (37 weeks 0 days) birth\n* Planning to breastfeed or pump during the study period\n* History of successful breastfeeding or pumping after a prior pregnancy\n* Between 6 weeks and 6 months postpartum (patients may be recruited at any time during the postpartum period, but the study period will not start until 6 weeks postpartum)\n* Ability to consent in English\n* Not meeting any exclusion criteria\n\nExclusion Criteria:\n\n* Preterm delivery\n* Perinatal mortality\n* History of difficulty breastfeeding\n* 3rd or 4th degree perineal laceration\n* Any contraindications to estrogen, including, but not limited to, breast cancer or a history of breast cancer, estrogen-dependent neoplasia, active deep vein thrombosis (DVT)\u002Fpulmonary embolism (PE) or a history of these conditions, active arterial thromboembolic disease (for example, stroke and MI) or a history of these conditions, known anaphylactic reaction, angioedema, or hypersensitivity to estrogen, hepatic impairment or disease, protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.","50 Years",{"count":635,"type":22},[252],"Sexual dysfunction is very common in the postpartum period and is more common in people who breastfeed or pump. This research study was designed to help determine whether postpartum patients who use vaginal estrogen cream while breastfeeding have improved sexual function compared to postpartum patients who do not.",[32,665,666],"Postpartum Sexual Dysfunction","Vaginal Atrophy",[668,669,670,671,144,672,673],"vaginal atrophy","postpartum","sexual dysfunction","dyspareunia","pumping","vaginal dryness","2026-03-06",{"date":647,"type":42},{"date":677,"type":42},"2025-02-22",{"date":679,"type":22},"2026-09-30",{"name":681,"class":49},"University Hospitals Cleveland Medical Center",{"id":683,"slug":684,"hasResults":12,"nctId":685,"briefTitle":686,"officialTitle":687,"acronym":688,"eligibilityCriteria":689,"healthyVolunteers":80,"sex":348,"minAge":4,"maxAge":4,"enrollmentInfo":690,"targetDuration":4,"studyType":60,"phases":692,"briefSummary":693,"conditions":694,"keywords":697,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":702,"lastUpdatePostDateStruct":703,"startDateStruct":705,"completionDateStruct":707,"leadSponsor":709,"locationsCount":50},"100624524","effect-of-combined-skin-to-skin-contact-and-kangaroo-care-on-breastfeeding-and-bonding-in-cesarean-born-newborns-100624524","NCT07410754","Effect of Combined Skin-to-Skin Contact and Kangaroo Care on Breastfeeding and Bonding in Cesarean-Born Newborns","The Effect of Consecutive Skin-to-Skin Contact Applied by the Mother and Father on Breastfeeding Parameters and Bonding in Babies Born by Cesarean Section","SSC-CS","Inclusion criteria:\n\n* Mothers who delivered by cesarean section\n* Mothers and fathers willing to participate and provide written informed consent\n* Newborns who are stable after birth\n* No health conditions in mothers or fathers that would prevent participation in skin-to-skin contact\n\nExclusion criteria:\n\n* Serious maternal or neonatal illness\n* Newborns requiring NICU admission\n* Mothers or fathers unwilling to participate\n* Any maternal or paternal condition preventing the implementation of skin-to-skin contact\n\nAdditional note:\n\n-Eligibility is based on biological sex (female for mothers, male for fathers, newborns of any sex), not on gender identity.",{"count":691,"type":22},60,[62],"This randomized controlled study aims to evaluate the effect of consecutive skin-to-skin contact applied by the mother and father on breastfeeding parameters and parent-infant bonding in babies born by cesarean section. The study includes two groups: an intervention group receiving consecutive skin-to-skin contact by the father followed by the mother, and a control group receiving routine postnatal care. Breastfeeding success and parental bonding will be assessed using validated measurement tools during the early postnatal period and follow-up.",[32,695,696,140],"Skin to Skin Contact","Cesarean Birth",[698,696,699,700,701],"Skin-to-Skin Contact","Breastfeeding Outcomes","Maternal Attachment","Paternal Attachment","2026-02-08",{"date":704,"type":42},"2026-02-13",{"date":706,"type":22},"2026-03",{"date":708,"type":22},"2026-07",{"name":209,"class":49},{"id":711,"slug":712,"hasResults":12,"nctId":713,"briefTitle":714,"officialTitle":715,"acronym":716,"eligibilityCriteria":717,"healthyVolunteers":80,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":718,"targetDuration":4,"studyType":60,"phases":719,"briefSummary":720,"conditions":721,"keywords":724,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":735,"lastUpdatePostDateStruct":736,"startDateStruct":738,"completionDateStruct":739,"leadSponsor":741,"locationsCount":50},"100598291","phase-1-pharmacokinetics-of-antituberculosis-drugs-in-breastfeeding-women-100598291","NCT07069582","Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women","Plasma and Breastmilk Exposures to Antituberculosis Drugs in Breastfeeding Women: an Open-label, Randomized, Six-arm, Single-dose, Pharmacokinetic Study","PRiMe","Inclusion Criteria:\n\nParticipants may enter the study if all of the following apply:\n\n1. Healthy breastfeeding women aged 18 years or older, with a minimum of 3 months and a maximum of 24 months after delivery of a healthy baby, and are not currently diagnosed with either TB infection or TB disease.\n2. Have a body weight between 25 and 100 kg.\n3. Provide written informed consent.\n\nExclusion Criteria:\n\nParticipants may not enter the study if any of the following criteria apply:\n\n1. Grade 3-4 abnormalities on baseline blood chemistry tests, including serum alanine aminotransferase (ALT), creatinine, or blood glucose.\n2. Grade 3-4 abnormalities on baseline hematological tests, including white blood count, platelets, or hemoglobin.\n3. Contraindications or history of hypersensitivity\u002Fintolerance to rifampicin, isoniazid, levofloxacin, rifapentine, or bedaquiline.\n4. Taking concomitant medications for TB disease, TB infection, diabetes mellitus, hypertension, HIV, cardiac disease or any other chronic diseases.\n5. Having a breastfed infant who was diagnosed with TB infection or TB disease and is currently on treatment.\n6. Pregnancy\n7. Have an active, acute illness at the time of study enrolment.",{"count":691,"type":22},[477],"This study is a sub-study of the SSTARLET trial (NCT06498414). The overall aim is to assess the pharmacokinetic profiles after taking a single dose of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in breastfeeding women and the excretion of these drugs in breast milk, with the hope of including breastfeeding women in future clinical trials of TPT, including expanding the inclusion criteria of the SSTARLET trial. In this study, healthy breastfeeding women who fulfill the eligibility criteria will be enrolled from several primary health care centers in Bandung, which will be referred to the TB Research Clinic of the Universitas Padjadjaran, Bandung, Indonesia. Ten participants will be randomized to each of the following six study arms:\n\n* Arm A: Single-dose rifampicin at 10 mg\u002Fkg body weight (RIF10).\n* Arm B: Single-dose rifampicin at 20 mg\u002Fkg body weight (RIF20).\n* Arm C: Single-dose isoniazid at 5 mg\u002Fkg body weight (INH5).\n* Arm D: Single-dose levofloxacin at 10-15 mg\u002Fkg body weight (LFX10-15).\n* Arm E: Single-dose rifapentine at 10 mg\u002Fkg body weight (RPT10).\n* Arm F: Single-dose bedaquiline at 400 mg (BDQ400).",[722,723,32],"Tuberculosis Infection","Healthy Volunteer",[725,726,727,728,729,730,731,732,733,734],"Tuberculosis infection","Latent tuberculosis infection","TBI","LTBI","Breastfeeding women","Rifampicin","Levofloxacin","Rifapentine","Isoniazid","Bedaquiline","2026-02-06",{"date":737,"type":42},"2026-02-10",{"date":420,"type":22},{"date":740,"type":22},"2026-10-31",{"name":742,"class":49},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre"]