[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"birth-outcomes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:birth-outcomes":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,74,103,132],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100549251","effect-of-a-mobile-health-intervention-on-birth-outcomes-100549251",false,"NCT06431581","Effect of a Mobile Health Intervention on Birth Outcomes","Effect of a Mobile Health Intervention on Birth Outcomes in a Tertiary Healthcare Facility in Nepal","Inclusion Criteria:\n\n* Pregnant women of age 18 years and above;\n* Pregnant with 13 to 27 weeks of gestation;\n* Planned to deliver a child at selected hospital;\n* Pregnant women who use smart phone;\n* Can read and understand Nepali language\n\nExclusion Criteria:\n\n* Pregnant women with vision impairment and diagnosed learning difficulties","FEMALE","18 Years",{"count":19,"type":20},494,"ESTIMATED","INTERVENTIONAL",[23],"NA","Globally, neonatal and infant mortality persist as challenging concerns, paralleled by a notable prevalence of low birth weight and preterm birth. Some of the factors contributing to these issues include poor maternal health and nutrition, maternal smoking, and insufficient maternal awareness. Despite global efforts to improve maternal, newborn, and child health, adverse birth outcomes remain significant challenges, particularly in low and middle-income countries (LMICs). A noteworthy observation is that not all pregnant women modify their behaviours for their and their baby's health due to lack of social support, fear and insecurity. Recognizing the potential for interventions during pregnancy to positively influence maternal, fetal, and neonatal health, this research underscores the role of Mobile Health (mHealth) technologies in leveraging information and communication technology for health service delivery.\n\nAccordingly, the study aims to evaluate the effect of mobile health intervention on birth outcomes in Nepal. In the initial phase, a qualitative study will be conducted to explore the views, informational needs and preferences of pregnant women regarding utilization of mHealth intervention. These insights will inform the development of user-centred educational videos and tailored mHealth interventions for pregnant women.\n\nA two-arm parallel randomized controlled trial will then assess the mHealth intervention's effect on the birth outcomes of the pregnant women attending the antenatal care clinic of selected hospital. The investigators will randomize pregnant women at gestational age 13-27 weeks into either a control group (who will receive standard care along with a control video and reminder phone call for follow-up) or an intervention group (who will receive standard care along with m-health intervention that includes educational video, short message service (SMS) and reminder phone call for follow up).\n\nFollow-up will be done from the time of enrolment until the first 24 hours after childbirth, focusing on evaluating the effect of m-Health intervention on birth outcomes (birth weight and gestational age at delivery). Data collection will utilize a self-constructed semi-structured questionnaire, along with validated questionnaires. The collected data will be analysed using STATA 14, contributing valuable insights into the potential effect of mHealth intervention on birth outcomes.",[26],"Birth Outcomes","RECRUITING","2026-06-19",{"date":30,"type":31},"2026-06-24","ACTUAL",{"date":33,"type":31},"2024-09-09",{"date":35,"type":20},"2027-04",{"name":37,"class":38},"Kathmandu University School of Medical Sciences","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":53,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100636659","maternal-methyl-nutrient-status-and-infant-neurodevelopment-study-100636659","NCT07568561","Maternal Methyl-Nutrient Status and Infant Neurodevelopment Study","Maternal Methyl-Nutrient Status During Pregnancy and Its Association With Infant Neurodevelopment: Exploring Potential Mechanisms","Inclusion Criteria for Pregnant Women\n\n* Aged 20-45 years\n* Singleton pregnancy\n* Receiving routine prenatal care at the study site and planning to deliver at Far Eastern Memorial Hospital\n\nExclusion Criteria for Pregnant Women\n\n* Diagnosed with major chronic diseases, including renal disease (defined as chronic kidney disease stage 3 or above or history of renal transplantation), liver disease (defined as liver cirrhosis or history of liver transplantation), or malignancy\n* Alcohol consumption during pregnancy\n* Diagnosed with eating disorders or psychiatric conditions that may impair the assessment of nutritional status\n\nInclusion Criteria for Newborns\n\n● Newborns delivered by mothers who participate in this study\n\nExclusion Criteria for Newborns\n\n* Diagnosed with congenital anomalies, epilepsy, or severe brain injury\n* Inability to complete neurodevelopmental assessments at 6 months, 1 year, and 2 years of age at the study site\n* Infants whose mothers are diagnosed with eating disorders or psychiatric conditions that may impair the assessment of nutritional status",true,"ALL","0 Days","45 Years",{"count":52,"type":20},240,"2 Years","OBSERVATIONAL","This prospective cohort study examines the relationship between maternal methyl-nutrient status during pregnancy and offspring neurodevelopment. It integrates maternal dietary, biomarker, genetic, and microbiome data and follows children up to 24 months.",[57,58,59,26,60,61,62,63,64],"Infant Neurodevelopment","Nutrition","Methylation","Pregnancy","Dietary Quality","Dietary Intake Assessment","Homocysteine","Trimethylamine N-oxide (TMAO)","2026-05-27",{"date":67,"type":31},"2026-05-29",{"date":65,"type":31},{"date":70,"type":20},"2029-01-18",{"name":72,"class":38},"Far Eastern Memorial Hospital",2,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":47,"sex":48,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":39},"100596299","an-agricultural-livelihood-intervention-for-pregnant-women-100596299","NCT07043647","An Agricultural Livelihood Intervention for Pregnant Women","A Randomized Controlled Trial of an Agricultural Livelihood Intervention to Improve Maternal and Newborn Health and Nutrition in Kenya: Mama Shamba","Inclusion Criteria:\n\n* Pregnant and 9-20 weeks gestation confirmed by ultrasound\n* singleton pregnancy\n* Age ≥16 years\n* moderate-severe household food insecurity or malnutrition (mid-upper arm circumference (MUAC) \\\u003C23 cm)\n* Access to land and permanent surface water\n* self-reported experience with farming\n\nExclusion Criteria:\n\n* Advanced HIV disease\n* Unable to provide written informed consent (use of an impartial witness is satisfactory if illiterate)\n* Plans to relocate outside the study area within 18 months","16 Years",{"count":83,"type":20},410,[23],"Scarcity of food is a leading cause of sickness and death in mothers and their newborns in sub-Saharan Africa. Use of locally acceptable agricultural interventions including provision of agricultural supplies, training and having model farms can go a long way to alleviate the ills of food scarcity among mothers and children in our region. This study is designed to learn whether an agricultural intervention might prevent food scarcity and illness among mothers and children. A total of 410 pregnant women will be enrolled from 9- 20 weeks of pregnancy, half living with HIV. Women will be randomly assigned to receive the intervention right away or to receive the intervention after the study is over if they are interested. Follow-up on enrolled participants will happen at a specified period of time, up to 12 months postpartum. The central hypothesis is that by empowering pregnant women with skills and commodities for sustainable farming, the intervention will lead to better maternal and infant health compared to control participants. The study intervention includes the provision of agricultural commodities (including irrigation pumps seeds, and other supplies) training on agriculture and business, and a demonstration farm where all trainings will be held and where women can harvest vegetables to bring home. The study aims to explore the impact of the intervention on health outcomes as well as socioeconomic and behavioral factors among the study population. This research will significantly advance scientific understanding of the importance of such agricultural interventions for pregnant women and their infants in the first year of life.",[87,60,26,88,89],"Food Insecurity","Livelihood Interventions","Infant Health Outcomes",[87,60,26,91,92,93],"Livelihood interventions","agricultural Interventions","Kenya","2025-12-08",{"date":96,"type":31},"2025-12-12",{"date":98,"type":31},"2025-09-05",{"date":100,"type":20},"2029-02-19",{"name":102,"class":38},"University of California, San Francisco",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":39},"100591760","effect-of-snoezelen-room-on-birth-process-100591760","NCT06984614","Effect of Snoezelen Room on Birth Process","Effect of Snoezelen Room on Birth Process: a Randomized Controlled Study","Inclusion Criteria:\n\n* Pregnant women who are planned to give birth vaginally in their 37th-42nd weeks of pregnancy,\n* who are in their first pregnancy, who do not have any vision,\n* hearing or communication problems,\n* who can speak Turkish and express themselves in Turkish,\n* who volunteer will be included in the study.\n\nExclusion Criteria:\n\n* Women with multiple pregnancies,\n* women who are planned to give birth by cesarean section,\n* women who give birth by cesarean section for any reason during the study,\n* women who develop any complications during pregnancy,\n* women with chronic diseases,\n* women with verbal, mental, etc. communication disabilities will not be included in the study.\n* Women who have instrumental delivery (with vacuum or forceps),\n* postpartum complications in the newborn, or complications related to episiotomy (such as 3rd and 4th degree laceration, hematoma) from the control or intervention groups will be excluded from the study.",{"count":111,"type":20},104,[23],"Aromatherapy, visual and auditory stimuli are used together in the Snoezelen room. Aromatherapy increases the production of endorphins, reduces the intensity of pain and distracts the attention from the pain. Music also blocks the transmission of nerve impulses to the spinal cord.Considering these effects, the study emerges as a new technology for the midwifery field in our country. Although the use of snoezelen rooms in the delivery environment is becoming increasingly widespread abroad, it has not been used in delivery services in any hospital in our country. The primary purpose of this study is to convert a room in the delivery room of the hospital into a Snoezelen room and have women complete their delivery process in this room, and the secondary purpose is to determine the effect of the Snoezelen room on the delivery process.\n\nThe primiparous pregnant women selected for the intervention and control groups will be informed about the purpose of the study and the applications by the research midwife or gynecologist following the birth and will be administered the \"Pregnant Information Form\", \"Visual Analog Scale (VAS)\", \"Fear of Childbirth Scale\", \"Birth Comfort Scale\", and after birth, the \"Birth Information Form\", \"Birth Satisfaction Scale\". The Beta Endorphin Level Recording Form will be filled out.",[26,115],"Birth",[117,118,119,120,121,122],"midwifery","birth process","snoezelen room","fear of birth","birth satisfaction","pregnancy","2025-05-20",{"date":125,"type":31},"2025-05-22",{"date":127,"type":31},"2025-01-11",{"date":129,"type":20},"2025-06-30",{"name":131,"class":38},"Sakarya University",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":140,"targetDuration":142,"studyType":54,"phases":4,"briefSummary":143,"conditions":144,"keywords":149,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":39},"100511166","progression-of-metabolic-syndrome-components-during-pregnancy-100511166","NCT05935904","Progression of Metabolic Syndrome Components During Pregnancy","The Progression of Metabolic Syndrome Components During Pregnancy, and the Risks for Adverse Pregnancy Outcomes in Jimma Zone, Southwest Ethiopia: A Prospective Cohort Study.","MetS_Preg","Inclusion Criteria:\n\n* Apparently healthy women with (or without) at least one of the 5 individual components of MetS will be enrolled in the study from each selected health institution if they meet all the inclusion criteria.\n\nInclusion criteria for the exposed group include additionally:\n\n1. Abdominal obesity defined as waist circumference ≥ 2 standard deviations (SD) for gestational age in the first half of pregnancy or presentational BMI \\>30 kg\u002Fm2, OR\n2. Raised triglycerides (\\>1.70 mmol\u002Fl \\[\\>150 mg\u002Fdl\\]), OR\n3. Reduced high-density lipoprotein cholesterol (\\\u003C1.29 mmol\u002Fl \\[\\\u003C50 mg\u002Fdl\\]), OR\n4. Raised blood pressure (BP) (i.e., systolic BP \\>130 mm Hg or diastolic BP \\>85 mm Hg), OR\n5. Raised plasma glucose (\\>5.6 mmol\u002Fl).\n\nExclusion Criteria:\n\n* Pregnant women with chronic hypertension that necessitates medication, diabetes (also under medication), or any severe chronic illness will not be eligible to participate in the study. Women who have HIV and who take antiretroviral therapy (ART) are also not eligible because of the side effect of ART. Additionally, non-consenting women, ≤18 years old, women who are planning to move outside the study area within the study timeframe due to job transfer or study leave, or those who are not willing to adhere to the prospective follow up visits will not be included in the study. Women whose ultrasound confirmed, twin pregnancy, congenital anomaly or fetal death in utero will not be included in the study.",{"count":141,"type":20},526,"7 Months","The goal of this cohort study is to investigate the underlying risk factors to develop metabolic syndrome (MetS) during pregnancy, and the associations of MetS and its indicators with birth outcomes in southwest Ethiopia. The study population consists of low-risk pregnant ladies in their first antenatal care visit (ANC), from Jimma Medical center.\n\nThe main question\\[s\\] it aims to answer are:\n\ni) How do MetS components progress during pregnancy, and what are the underlying risk factors? ii) What is the association between MetS components during early- and late pregnancy and adverse pregnancy outcomes? iii) What is the knowledge, attitude and practices of women toward dietary habits, food taboos, and cultural beliefs during pregnancy?\n\nThe study population consists of low-risk pregnant ladies in their first trimester (\\\u003C15 weeks of pregnancy) in their first antenatal care visit (ANC) who will be followed up until one-month postpartum.\n\nEnrolled women will be assessed four times: at enrolment ≤15 weeks of pregnancy, mid-pregnancy (at 24 weeks), and late pregnancy (at 36 weeks), and within two weeks post-partum for:\n\n1. Sociodemographic data\n2. Dietary intake\n3. Biochemical analyses\n4. Maternal anthropometry:\n5. Body composition in a subsample.\n6. Knowledge, attitudes and practices of dietary practices during pregnancy\n7. Pregnancy and birth outcomes: During the final visit, new born babies will be assessed for Apgar score, weight, length, and head circumference. The mother will be examined for general health and mode of delivery.",[145,146,26,147,148],"Metabolic Syndrome","Pregnant Women","Dietary Habits","Knowledge, Attitudes, Practice",[150,151,60,152,153],"Metabolic syndrome","Cohort","Birth outcomes","Food culture","2024-07-04",{"date":156,"type":31},"2024-07-08",{"date":158,"type":31},"2023-06-27",{"date":160,"type":20},"2024-12-30",{"name":162,"class":38},"University Ghent"]