[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Women and Infants Hospital of Rhode Island\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":524},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,50,76,90,119,143,173,200,234,261,285,316,348,372,397,428,458,478,503],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100054124","feasibility-and-acceptability-of-a-novel-digital-intervention-to-prevent-paternal-postpartum-depression-100054124",false,"NCT07594743","Feasibility and Acceptability of a Novel Digital Intervention to Prevent Paternal Postpartum Depression","Pilot Randomized Trial of Together in Parenting, a Novel Digital Paternal Postpartum Depression Prevention Intervention","TIP RCT","Inclusion Criteria:\n\n1. English-speaking (for now, TIP is only available in English)\n2. age \\>18 years old,\n3. smartphone ownership or access to home internet,\n4. partner or patient received or receiving prenatal care from a resident or nurse-practitioner\u002Fmidwifery clinic at the Obstetrics and Gynecologic Care Center (OGCC) at Women \\& Infants Hospital of Rhode Island (WIHRI) or receiving an ultrasound at the WIHRI's Prenatal Diagnosis Center ,\n5. planned delivery or status post delivery at WIHRI.\n\nExclusion Criteria:\n\n1. Any self-reported active diagnosis or history of mental health conditions including depression, anxiety, or other psychiatric condition, as per patient report;\n2. Endorsing active suicidality on intake survey or screening positive on the MDS (≥13)16 or GAD-7 (≥8) at time of enrollment;\n3. prisoners;\n4. infant with genetic abnormality, significant anatomic malformation, or NICU admission at time of enrollment;\n5. inability to consent. If new results on the MDS or GAD-7 indicate a positive screening or the father's infant(s) is diagnosed with a genetic abnormality, significant anatomic malformation, or NICU admission after the enrollment and randomization period, the father will still be eligible to continue participation in the study. This information will be tracked in the REDCap database.",true,"ALL","18 Years",{"count":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"NA","Postpartum depression (PPD) occurs almost as often among men as it does among women. However, while there have been multiple programs designed to prevent maternal PPD, few, if any, interventions exist that have been created specifically to prevent paternal PPD. After engaging in evidence-based qualitative research with soon-to-be or new fathers, a novel interpersonal-therapy based digital program was created to prevent paternal PPD called Together in Parenting (TIP), which comprises multiple podcasts and digital educational handouts. The proposed pilot study will examine the feasibility and acceptability of using TIP as a paternal PPD intervention, will determine the optimal timing of administering TIP to future\u002Fnew fathers, and will generate preliminary estimates of effect of the intervention to support a future efficacy study.",[28,29],"Paternal Postpartum Depression","Postpartum Anxiety",[31,32,33,34,35,36],"paternal postpartum depression","paternal postpartum anxiety","maternal postpartum depression","postpartum perceived stress","maternal postpartum anxiety","dyadic adjustment","RECRUITING","2026-07-09",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":41},"2026-07-07",{"date":45,"type":22},"2027-12-01",{"name":47,"class":48},"Women and Infants Hospital of Rhode Island","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":17,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":73,"leadSponsor":75,"locationsCount":49},"100587601","bringing-medicines-for-hiv-prevention-to-a-family-planning-clinic-100587601","NCT06930508","Bringing Medicines for HIV Prevention to a Family Planning Clinic","Implementing HIV Pre-Exposure Prophylaxis in a Family Planning Clinic: A Study of Feasibility and Acceptability (Aka The Pilot Fish Study)","This study will include patient participants who:\n\n* Are age 16 or older\n* Are presenting for care at the Women and Infants Hospital of Rhode Island Family Planning Clinic\n* Speak English or Spanish\n* Have decisional capacity\n\nThis study will exclude patient participants who:\n\n\\- Are currently seeking abortion care\n\nThis study will include physician participants who:\n\n\\- Provide care at the Women and Infants Hospital of Rhode Island Family Planning Clinic\n\nThis study will not have any specific exclusion criteria for physician participants.","16 Years",{"count":59,"type":22},83,[25],"The goal of this clinical trial is to understand what patients and physicians think about providing medications to prevent HIV transmission to patients in a family planning clinic. These medications are known as pre-exposure prophylaxis, or PrEP. The main questions to answer are:\n\n1. Do patients find it acceptable to be asked about, and offered, PrEP during their visit to a family planning clinic?\n2. What things make it easier or harder to ask about PrEP in a family planning clinic setting?\n3. What things make it easier or harder to begin PrEP in a family planning clinic setting?\n\nPatient participants:\n\n1. Will receive standardized counseling about PrEP.\n2. Will have the opportunity to begin PrEP as part of their routine, ongoing care.\n3. Will be asked to complete a survey about their experiences.\n\nPhysician participants:\n\n1. Will receive standardized education about PrEP.\n2. Will talk to patient participants about PrEP, and support patient participants who want to begin PrEP.\n3. Will be asked to complete pre-and post-study surveys about their experiences.\n4. May be asked to complete a post-study in-depth interview about their experiences.",[63,64],"HIV","PrEP",[66,67,68],"HIV PrEP screening","HIV PrEP initiation","ob\u002Fgyn","2026-05-28",{"date":71,"type":41},"2026-05-29",{"date":69,"type":41},{"date":74,"type":22},"2026-07-31",{"name":47,"class":48},{"id":77,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":26,"conditions":80,"keywords":81,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":89,"locationsCount":4},"100638818",{"count":21,"type":22},[25],[28,29],[31,32,33,34,35,36],"NOT_YET_RECRUITING","2026-05-12",{"date":85,"type":41},"2026-05-19",{"date":87,"type":22},"2026-06-01",{"date":45,"type":22},{"name":47,"class":48},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":98,"minAge":19,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":23,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":49},"100581404","collaborative-care-model-for-perinatal-wellness-support-services---population-level-equity-centered-systems-change-100581404","NCT06849869","Collaborative Care Model for Perinatal Wellness Support Services - Population-Level Equity-Centered Systems Change","Collaborative Care Model for Perinatal Depression Support Services -- Population-Level Equity-Centered Systems Change (COMPASS-PLUS): A Hybrid Type 2 Cluster Randomized Trial","COMPASS+","Inclusion Criteria:\n\n* all pregnant and postpartum people receiving care at participating sites, who reach a gestational age of 20 or more weeks\n* age \\> 17 years\n\nExclusion Criteria:\n\n* age \\\u003C 18 years\n* all pregnant and postpartum people receiving care at participating sites, who do not reach a gestational age of 20 or more weeks","FEMALE",{"count":100,"type":22},14820,[25],"The collaborative care model (CCM) is a health services intervention that integrates mental health care in primary care settings. The goal of this study is to adapt the CCM to the perinatal care context, including community co-designed adaptations to enhance health equity (COMPASS+). The main objectives of the study are to:\n\n1. Evaluate the effect of COMPASS+ on depression symptom outcomes. Specifically we will evaluate population-level depression symptom trajectories and the prevalence of suicidal ideation among. We will also measure rates of depression response and remission for those who have elevated screen scores (i.e., PHQ9 ≥ 10)\n2. Adapt, optimize, and evaluate COMPASS+ implementation strategies to the unique context of perinatal care and evaluate implementation outcomes. The RE-AIM framework will be used to evaluate implementation outcomes (acceptability, appropriateness, feasibility, and fidelity). We hypothesize that variability in effectiveness outcomes will be attributable to variability in fidelity to the implementation strategies or in implementation outcomes.\n3. Identify the effect of COMPASS+ on perinatal depression and implementation outcomes across racial and ethnic subgroups.",[104],"Perinatal Mental Health",[106,107,108,109,110],"health services interventions","mental health","collaborative care model","compass+","perinatal care","2026-04-14",{"date":113,"type":41},"2026-04-20",{"date":115,"type":41},"2024-06-03",{"date":117,"type":22},"2028-06-30",{"name":47,"class":48},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":98,"minAge":19,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":49},"100626553","community-partnered-doula-support-for-neonatal-intensive-care-unit-families-100626553","NCT07437131","Community-Partnered Doula Support for Neonatal Intensive Care Unit Families","Inclusion Criteria:\n\n* baby admitted to NICU at Women and Infants Hospital\n* anticipated NICU stay greater than or equal to 2 weeks\n* English or Spanish speaking\n\nExclusion Criteria:\n\n* Infant anticipated stay \\\u003C 2 weeks",{"count":126,"type":22},60,[25],"The goal of this clinical trial is to learn if pairing families who have a baby in the Neonatal Intensive Care Unit with a community doula improves stress. The main questions it aims to answer are:\n\nResearchers will compare stress levels among families with a baby in the neonatal intensive care unit who are paired with a community doula compared to those who receive standard care.\n\nParticipants will:\n\nComplete baseline surveys and physical assessments (blood pressure and blood sample collection) and again after six weeks If they are randomized to receive doula support, they will meet with the doula weekly to receive additional parental support for six weeks",[130,131],"Infant Admitted to Neonatal Intensive Care Unit (NICU)","Doula Support",[133,134],"NICU, infant in NICU","doula support","2026-03-31",{"date":137,"type":41},"2026-04-07",{"date":139,"type":41},"2026-03-10",{"date":141,"type":22},"2026-12-01",{"name":47,"class":48},{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":98,"minAge":4,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":153,"briefSummary":154,"conditions":155,"keywords":160,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},"100627264","rhode-island-community-based-maternal-support-services-100627264","NCT07446374","Rhode Island Community-based Maternal Support Services","Rhode Island Community-based Maternal Support Services (RI COMSS) Bundle for Advancing Perinatal Health Equity","RICOMSS","Inclusion Criteria:\n\n* All birthing people receiving perinatal care (prenatal, postpartum) at Women and Infants Hospital (WIH) and its affiliated clinics\n\nExclusion Criteria:\n\n* Anyone not meeting the above criteria",{"count":152,"type":22},3000,[25],"The purpose of this project is to improve perinatal health outcomes in Rhode Island by bringing together the hospital, community health workers (CHWs), doulas, and community-based organizations to build a service delivery model that addresses care coordination and social determinants of health (SDOH) as a part of a concerted effort towards achieving equitable perinatal health outcomes. Over 4 years, the hospital-led project team will implement the community-based maternal support services (COMSS) bundle in 6 affiliated clinics, including care coordination, doula care, and referrals and linkages to community-based organizations that address key SDOH (food, housing, transportation). Maternal and infant health outcomes will be compared pre and post program implementation.\n\nThe central hypothesis is that COMSS will reduce adverse maternal and infant outcomes and associated racial disparities.",[156,157,158,159],"Perinatal Outcomes","Social Determinants of Health (SDOH)","Health Disparity, Minority and Vulnerable Populations","Pregnancy",[161,162,163],"pregnancy","social determinants of health","perinatal outcomes","2026-03-02",{"date":166,"type":41},"2026-03-03",{"date":168,"type":41},"2025-05-19",{"date":170,"type":22},"2028-12",{"name":47,"class":48},7,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":98,"minAge":19,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":183,"conditions":184,"keywords":190,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":4},"100610074","phase-3-cardiovascular-protection-after-preeclampsia-with-enalapril-100610074","NCT07222852","Cardiovascular Protection After Preeclampsia With Enalapril","CAPP-E","Inclusion Criteria:\n\n* Postpartum individuals\n* ≥18 years old\n* Hypertensive disorder of pregnancy\n* Enrolled in Women and Infants Hospital Hypertension Equity remote monitoring program.\n\nExclusion Criteria:\n\n* Maternal cardiac disease\n* Individuals with pre-pregnancy hypertension or diabetes\n* Allergy or contraindication to enalapril",{"count":126,"type":22},[182],"PHASE3","The purpose of this study is to learn if postpartum women are willing to be randomized to different blood pressure medicines after delivery and how that affects blood pressure in women with hypertensive disorders of pregnancy.",[185,186,187,188,189],"Preeclampsia","Hypertensive Disorder of Pregnancy","Hypertension","Gestational Hypertension","Gestational Hypertension After Childbirth",[191],"postpartum hypertension, preeclampsia, gestational hypertension","2025-10-29",{"date":194,"type":41},"2025-10-30",{"date":196,"type":22},"2025-11-15",{"date":198,"type":22},"2027-10-15",{"name":47,"class":48},{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":17,"sex":18,"minAge":207,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":219,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":49},"100505449","combined-oral-motor-stimulation-and-language-on-preterm-infant-feeding-100505449","NCT05861531","Combined Oral Motor Stimulation and Language on Preterm Infant Feeding","The Combined Association of an Oral Motor Stimulation and Language Intervention on Preterm Infant Feeding","Inclusion Criteria:\n\n* 23-30 weeks\n* English and Spanish speaking\n\nExclusion Criteria:\n\n* Major congenital anomalies\n* Surgical necrotizing enterocolitis\n* Non-English and Non-Spanish speaking","23 Weeks","30 Weeks",{"count":210,"type":22},124,[25],"This is a randomized controlled trial to study an oromotor stimulation in combination with a reading curriculum in the NICU among preterm infants using oral muscle exercises, Language Environment Analysis (LENA) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient oral feeding and language outcomes for preterm infants.",[214,215,216,217,218],"Language Delay","Language Development","Feeding; Difficult, Newborn","Mother-Infant Interaction","Maternal Behavior",[220,221,222,223,224,225],"Neonatal feeding","Neonatal language","Oromotor stimulation","Newborn reading","Parent infant interaction","LENA","2025-09-10",{"date":228,"type":41},"2025-09-17",{"date":230,"type":41},"2025-07-01",{"date":232,"type":22},"2030-07-01",{"name":47,"class":48},{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":17,"sex":98,"minAge":19,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":23,"phases":243,"briefSummary":244,"conditions":245,"keywords":249,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":49},"100506995","early-diagnosis-and-intervention-for-fetal-malposition-in-active-labor-and-its-impact-on-mode-of-delivery-100506995","NCT05881629","Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery","Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Maternal age \\>18\n* Term gestation (\\>37 weeks)\n* Singleton pregnancy\n* Spontaneous or induced active labor (cervical dilation 6-9cm)\n* Epidural anesthesia\n* Cephalic fetal presentation, OP\u002FOT position diagnosed by bedside ultrasound\n* Continuous external fetal monitoring\n* Ability to consent\n\nExclusion Criteria:\n\n* Multiple gestations\n* Unanesthetized labor\n* Known fetal anomalies\n* Known intrauterine fetal demise\n* Inability to consent",{"count":242,"type":22},200,[25],"The goal of this randomized trial is to test if changing a person's position in labor can increase the chances of delivering their baby vaginally.\n\nSpecifically, it aims to answer the questions:\n\n* In fetuses who are facing upwards (occiput posterior, OP) or sideways (occiput transverse, OT) during labor, does changing the patient's position during active labor to a side-lying posture with a peanut ball increase the chances of them having a successful, spontaneous vaginal delivery?\n* Does changing the patient's position in active labor affect the position of the baby at the time of delivery?\n* Do intentional position changes in labor impact patient-perceived autonomy during their labor and delivery experience?\n\nParticipants will:\n\n* Receive an ultrasound during labor to determine the position of their baby\n* Be asked to adopt a specific position in labor (side-lying with peanut ball) if they are randomized to the study group\n* Receive additional ultrasounds during labor to assess their baby's position\n* Fill out a questionnaire about their labor experience following the delivery of their baby",[246,247,248],"Cesarean Delivery Affecting Fetus","Labor Dystocia","Labor Complication",[250,251,252],"fetal malposition","occiput posterior","occiput transverse","2025-09-03",{"date":255,"type":41},"2025-09-11",{"date":257,"type":41},"2024-05-01",{"date":259,"type":22},"2026-09-01",{"name":47,"class":48},{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":269,"phases":4,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":4},"100603237","accuracy-of-interstitial-continuous-glucose-sensors-in-neonates-100603237","NCT07133906","Accuracy of Interstitial Continuous Glucose Sensors in Neonates","Inclusion Criteria:\n\n* women aged 18 years or older\n* speaks English, Spanish, Portuguese, or Haitian Creole\n* pregnant \\>24 weeks gestation with singleton pregnancy\n\nExclusion Criteria:\n\n* known concomitant maternal or fetal condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff\n* plans to deliver at a hospital other than Women and Infants Hospital of Rhode Island",{"count":268,"type":22},114,"OBSERVATIONAL","Low blood sugar in newborns is common and if prolonged or untreated may place them at increased risk for later learning and behavior challenges. Currently, we measure newborn glucose with at least four painful heel sticks, missing one in four episodes of low blood sugar. The goal of this observational study is to develop a less invasive approach to glucose monitoring, developed for newborns, that provides more frequent glucose measurements. We will also measure how a pregnant woman's health impacts newborn glucose, and how newborn glucose is linked to brain oxygen saturation and development.",[272,273,274,275,276],"Neonatal Hypoglycemia","Gestational Diabetes","Maternal Obesity Complicating Pregnancy","Small-for-gestational Age","Large-for-gestational Age","2025-08-13",{"date":279,"type":41},"2025-08-21",{"date":281,"type":22},"2025-09",{"date":283,"type":22},"2027-06",{"name":47,"class":48},{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":98,"minAge":19,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":299,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":49},"100598916","prenatal-genetics-chatbot-trial-prenatal-geneie-100598916","NCT07077707","Prenatal Genetics Chatbot Trial: Prenatal GENEie","A Randomized Trial of Chatbot for Prenatal Genetic Counseling","Inclusion Criteria:\n\n* English or Spanish speaking with ability to read and write\n* Gestational age \\\u003C20 weeks\n* Access to smartphone or tablet (through personal use or study)\n\nExclusion Criteria:\n\n* Patients who have already had genetic counseling related to current pregnancy\n* h\u002Fo trisomy, major fetal anomaly. or aneuploidy in previous pregnancy\n* Parent with Robertsonian translocation\n* Twins, vanishing twin, multi-gestation pregnancy\n* Fetal anomaly noted in early pregnancy\n* In- vitro fertilization with pre-implantation genetic testing (PGT-A or PGT-M)","55 Years",{"count":294,"type":22},1470,[25],"During pregnancy, all pregnant people are offered tests to look for genetic conditions in the baby. However, there isn't a standard way of giving this information to patients. Doctors have a lot of things to discuss during the first prenatal visit and don't always have time to explain genetics in detail. Also, not everyone has access to genetic counselors. Prenatal genetics can be confusing, especially for people who haven't had a lot of formal education or who speak languages other than English. There might be misunderstandings about what these tests can find and what their benefits or risks are for these tests.\n\nMobile apps, like chatbots, could be a helpful way to give information about prenatal genetics. Almost everyone has a cell phone, and a chatbot can let people learn at their own speed and whenever they want.\n\nThe goal of this study is to see if a chatbot app Prenatal GENEie can teach pregnant women about prenatal genetics, and compare the chatbot to talking with a genetic counselor in person. The study wants to answer these main questions:\n\n* Does the Prenatal GENEie help pregnant patients learn about prenatal genetics the same way as a meeting with a genetic counselor?\n* Can the Prenatal GENEie and in-person counseling both help people make decisions about whether they want prenatal genetic testing?\n\nThe researchers will compare the chatbot Prenatal GENEie with in-person counseling to see if the chatbot teaches people about prenatal genetics in a similar way.\n\nParticipants will:\n\n* Take a test to check what they already know about prenatal genetics prior to the intervention\n* Use the chatbot or have an in-person meeting with a genetic counselor\n* Take a test after using the chatbot or meeting with a counselor to see how much their knowledge has improved\n* Fill out a survey about how comfortable they feel with their decision to do or not do prenatal genetic testing",[298],"Genetic Counseling",[300,301,302,303,304,305,306,307],"prenatal genetics","prenatal testing","mobile application","chatbot","patient education","aneuploidy","decisional conflict","genetics health literacy","2025-07-22",{"date":310,"type":41},"2025-07-28",{"date":312,"type":22},"2026-01-01",{"date":314,"type":22},"2029-03-31",{"name":47,"class":48},{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":98,"minAge":19,"maxAge":324,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":328,"conditions":329,"keywords":333,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":347},"100580866","rhode-island---statewide-postpartum-hypertension-remote-surveillance-100580866","NCT06842875","Rhode Island - Statewide Postpartum Hypertension Remote Surveillance","Effect of a Technology-based Collaborative Model on Persistent Hypertension and Preventive Care Attendance Among Postpartum People With Hypertensive Disorders of Pregnancy","RI-SPHERES","Inclusion Criteria:\n\n* Postpartum patient aged 18 years or more at any birthing hospital in Rhode Island\n* Diagnosed during pregnancy or after delivery with hypertensive disorder of pregnant\n* English-, Spanish-, Portuguese-, or Haitian-Creole-speaking\n* Smartphone ownership\n\nExclusion Criteria:\n\n* Prior enrollment in this trial\n* Prisoners or incarcerated people\n* Inability or unwillingness to provide informed consent\n* Inability to communicate with study team, despite an interpreter","60 Years",{"count":326,"type":22},1536,[25],"This is a hybrid type 1 non-inferiority implementation effectiveness trial among postpartum patients with hypertension (N=1536) that will test the hypothesis that RI-SPHERES (a technologically enabled collaborative care model) is non-inferior to a standard self-measured blood pressure program in terms of persistent hypertension at six weeks postpartum and preventive care receipt within one year of delivery.",[330,331,332],"Hypertension in Pregnancy","Postpartum Preeclampsia","Postpartum Complication",[334,335,336,108,337,338],"postpartum hypertensive disorders of pregnancy","postpartum preeclampsia","digital health","population health","self-measured blood pressure","2025-06-12",{"date":341,"type":41},"2025-06-17",{"date":343,"type":41},"2025-04-15",{"date":345,"type":22},"2029-03-01",{"name":47,"class":48},5,{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":98,"minAge":19,"maxAge":356,"enrollmentInfo":357,"targetDuration":4,"studyType":23,"phases":359,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":371},"100474807","phase-3-intravenous-versus-oral-iron-for-treating-iron-deficiency-anemia-in-pregnancy-100474807","NCT05462704","Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy","Double-blind Placebo-controlled Multicenter Randomized Trial of Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy","IVIDA2","Inclusion Criteria:\n\n* Pregnant women between the ages of 18-45\n* Singleton gestation\n* Iron-deficiency anemia (serum ferritin \\\u003C30ng\u002FmL and Hb\\\u003C11 g\u002FdL)\n* At 13-30 weeks gestation\n* Plan to deliver at participating hospital\n\nExclusion Criteria:\n\n* Non-iron-deficiency anemia e.g thalassemia, sickle cell disease, B12 or folate deficiency, hypersplenism.\n* Malabsorptive syndrome, inflammatory bowel disease, gastric bypass, or sensitivity to oral or IV iron\n* Multiple gestation\n* Inability or unwillingness to provide informed consent\n* Inability to communicate with members of the study team, despite the presence of an interpreter\n* Planned delivery at a non-study affiliated hospital","45 Years",{"count":358,"type":22},300,[182],"Double blind, placebo controlled, multicenter randomized trial in pregnant women in the U.S. (N=300) to test the central hypothesis that IV iron in pregnant women with IDA (Hb\\\u003C11 g\u002FdL and ferritin\\\u003C30 ng\u002FmL) at 13 - 30 weeks will be effective, safe and cost-effective in reducing severe maternal morbidity-as measured by maternal anemia at delivery-and will also improve offspring neurodevelopment.",[362,159],"Iron Deficiency Anemia","2025-06-05",{"date":365,"type":41},"2025-06-10",{"date":367,"type":41},"2023-01-17",{"date":369,"type":22},"2027-03-31",{"name":47,"class":48},8,{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":11,"sex":98,"minAge":19,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":23,"phases":380,"briefSummary":381,"conditions":382,"keywords":386,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":396,"locationsCount":49},"100590585","phase-3-topical-estrogen-brief-intervention-to-improve-postoperative-experience-for-transgender-men-undergoing-hysterectomy-100590585","NCT06969326","Topical Estrogen: Brief Intervention to Improve Postoperative Experience for Transgender Men Undergoing Hysterectomy","Inclusion Criteria:\n\n1. Gender diverse\u002Ftransgender men\n2. Age 18 or older\n3. Have been on testosterone for at least 6 months with plan to undergo gender-affirming hysterectomy and are willing to be randomized to the use of topical estrogen postoperatively.\n4. Have stable physical and mental health\n5. No contraindications to estrogen therapy\n6. Must be proficient in English or Spanish\n7. Must have access to a device to receive text messages for study follow up\n8. Must agree to allow their medical data to be used for research purposes\n\nExclusion Criteria:\n\n1. Under age 18\n2. Have not been on testosterone for at least 6 months prior to planned hysterectomy\n3. Known allergy to topical estrogen",{"count":379,"type":22},48,[182],"The purpose of this study is to determine if applying a single dose of topical estrogen cream in the operating room at the end of your hysterectomy (removal of uterus and cervix) improves the postoperative experience with bleeding and potential symptoms of dysphoria (a feeling of discomfort or distress). Topical estrogen cream is sometimes used if patients have increased risk of bleeding with surgery but is not currently utilized in a consistent way. This study aims to answer the question of whether this is a helpful treatment and should be included in standard postoperative care.",[383,384,385],"Postoperative Bleeding","Gender Dysphoria","Hysterectomy",[387,388,389],"gender dysphoria","gender affirmation","hysterectomy","2025-05-08",{"date":392,"type":41},"2025-05-13",{"date":394,"type":41},"2025-05-01",{"date":141,"type":22},{"name":47,"class":48},{"id":398,"slug":399,"hasResults":11,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":11,"sex":98,"minAge":19,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":407,"briefSummary":409,"conditions":410,"keywords":413,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":49},"100589350","phase-4-methenamine-hippurate-following-intradetrusor-onabotulinumtoxina-injection-100589350","NCT06953271","Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection","Methenamine Hippurate Compared to Typical Antibiotic Prophylaxis in the Prevention of Urinary Tract Infection Following Intradetrusor OnabotulinumtoxinA Injection for Treatment of Overactive Bladder: a Randomized Controlled Non-Inferiority Trial","META","Inclusion Criteria:\n\n* 18 years of age or older\n* undergoing intradetrusor BOTOX-A injections in the office setting for overactive bladder\n\nExclusion Criteria:\n\n* cisgender male individuals\n* neurogenic reasons for bladder symptoms (i.e. spinal cord injury, multiple sclerosis, etc.)\n* known allergy and\u002For contraindication to methenamine hippurate\n* currently already taking methenamine hippurate at the time of the procedure\n* taking antibiotics for any reason on the day of their BOTOX-A procedure\n* positive UTI at time of procedure (positive dip at time of procedure)\n* history of bladder cancer\n* history of pelvic radiation\n* surgically altered detrusor muscle\n* pre-procedural need for catheterization\n* diagnosis of Interstitial Cystitis\u002FPainful Bladder Syndrome (IC\u002FPBS)\n* pregnant or lactating individuals",{"count":406,"type":22},164,[408],"PHASE4","The goal of this clinical trial is to compare methenamine hippurate prophylaxis to routine antibiotic prophylaxis following onabotulinumtoxinA (BOTOX-A) injections in women with overactive bladder (OAB). Participants will be randomly selected to receive one of the two post-procedural prophylaxis medications. The primary outcome measure will be urinary tract infection (UTI) rates within 30 days from the BOTOX-A procedure. Secondary outcomes will assess patient satisfaction with the two post-procedural prophylaxis medications.",[411,412],"Overactive Bladder (OAB)","Urinary Tract Infection (Diagnosis)",[414,415,416,417,418,419,420],"Overactive Bladder","onabotulinumtoxinA","Methenamine","Urinary Tract Infection","BOTOX-A","UTI","OAB","2025-04-23",{"date":394,"type":41},{"date":424,"type":22},"2025-05-15",{"date":426,"type":22},"2027-01-01",{"name":47,"class":48},{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":17,"sex":18,"minAge":435,"maxAge":436,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":439,"briefSummary":440,"conditions":441,"keywords":445,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":49},"100526507","phase-4-assessing-interventions-to-increase-tdap-acceptance-for-non-birthing-partners-in-pregnancy-100526507","NCT06135636","Assessing Interventions to Increase Tdap Acceptance for Non-birthing Partners in Pregnancy","ITAPP","Inclusion Criteria:\n\n1. Partners of pregnant patients who are receiving their prenatal care at the OGCC\n2. 19-50 years old: This age range was selected as 19 years is both the age at which adult Tdap vaccination is recommended by the CDC as well as the age for the State supplied adult Tdap and Influenza Vaccines. Fifty years old is the upper limit of \"reproductively aged individuals, the target population for this study.\n3. Have not or are unsure if they have received the adult Tdap vaccine or booster in the last 10 years: In addition to the CDC recommendation for adult Tdap vaccination and Td or Tdap booster every 10 years, the CDC recommends vaccination for any adult who is unsure of their vaccination status to ensure they are vaccinated as repeat vaccination does not cause additional harm.\n4. Fluency in English or Spanish: Consents, surveys, and Tdap and cocooning information will be available in both languages.\n\nExclusion Criteria:\n\n1. Latex allergy: Contraindication to the state supplied Tdap vaccine\n2. Lethal fetal anomaly diagnosed prior to enrollment to prevent undue distress with follow-up postpartum","19 Years","50 Years",{"count":438,"type":22},150,[408],"The goal of this randomized control trial is to assess if prenatal vaccine education and in-office vaccination administration for non-birthing partners of pregnant patients increases Tdap vaccination rates compared to usual care.\n\nThe main question\\[s\\] it aims to answer are:\n\n* To assess whether compared to standard prenatal care, targeted prenatal education regarding Tdap vaccination recommendations with and without in office vaccination opportunities improves Tdap uptake among non-birthing partners of pregnant patients.\n* To assess whether non-birthing partners presenting for Tdap vaccination are willing to accept dual vaccination with Tdap and influenza.\n\nParticipants will receive direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery with or without the option to receive Tdap at their convenience at the WIH obstetric care clinic.\n\nIf there is a comparison group: Researchers will compare \"Upfront Education\" and \"Upfront Education and Vaccination Administration\" to \"Usual care\" to see if education and\u002For the offer for vaccination in the office increases Tdap vaccine acceptance for non-birthing partners.",[442,443,444],"Non-birthing Partner Vaccination in Pregnancy","Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination","Vaccine Exposure During Pregnancy",[446,447,448,449,159],"Tdap","Vaccine","Vaccine access","Non-birthing partner","2024-09-18",{"date":452,"type":41},"2024-09-20",{"date":454,"type":41},"2024-05-28",{"date":456,"type":22},"2025-06-30",{"name":47,"class":48},{"id":459,"slug":460,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":11,"sex":98,"minAge":19,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":23,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":49},"100474448","rct-of-pain-perception-with-fast-and-slow-tenaculum-application-100474448","NCT05458037","RCT of Pain Perception With Fast and Slow Tenaculum Application","A Randomized Controlled Trial of Pain Perception With Fast and Slow Tenaculum Application to the Uterine Cervix","Inclusion Criteria:\n\n1. plans for IUD insertion or endometrial biopsy;\n2. 18 to 49 years of age;\n3. not taken analgesics or anxiolytics in the previous 24 hours;\n4. the ability and are willing to give informed consent.\n\nExclusion Criteria:\n\n1. Do not speak English unless interpreter present;\n2. Taken any narcotic or opiate medication in the last 24 hours.\n3. Taken any recreational or illegal drugs in the last 24 hours, such as marijuana, heroin, cocaine, crack, or methamphetamines.\n4. Taken any anti-anxiety medication or drug in the last 24 hours.\n5. Taken any NSAIDS or Tylenol in the last 12 hours.",{"count":438,"type":22},[25],"This project will be a randomized controlled trial (RCT) measuring pain perception with two different tenaculum placement techniques on the uterine cervix. A tenaculum is an instrument used to hold the cervix (the opening to the uterus or womb) in place. The trial will measure pain perception with a Visual Analog Scale (VAS) from 0 to 100 mm for two different tenaculum placement techniques, fast and slow closure on the uterine cervix. The main objective of this study is to determine if there is a difference in pain perception with fast compared to slow tenaculum placement techniques on the uterine cervix. We hypothesize that the slow technique will be perceived as less painful for subjects as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). Subsidiary objectives include describing overall pain levels during the procedure.",[469,470],"Pain, Acute","Pain, Procedural",{"date":472,"type":41},"2024-05-03",{"date":474,"type":41},"2020-09-29",{"date":476,"type":22},"2026-12",{"name":47,"class":48},{"id":479,"slug":480,"hasResults":11,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":11,"sex":98,"minAge":19,"maxAge":486,"enrollmentInfo":487,"targetDuration":4,"studyType":23,"phases":489,"briefSummary":490,"conditions":491,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":502},"100468639","novel-vacuum-induced-hemorrhage-control-for-postpartum-hemorrhage-100468639","NCT05382403","Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage","Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage: a Multicenter Randomized Trial","NOVIC","Inclusion Criteria:\n\n* 18 years or older\n* Delivery at 34 weeks or greater\n* Cumulative blood loss \\>1000ml within 24 hours after delivery\n* Uterine atony\n* Receipt of first-line uterotonics\n* Cervix at least 3cm dilated at cesarean section\n\nExclusion Criteria:\n\n* Patient unwilling or unable to provide informed consent\n* Retained placenta or other known cause of postpartum hemorrhage\n* Placenta accreta spectrum\n* Coagulopathy\n* Rupture uterus\n* Surgical management immediately needed for life-threatening bleeding\n* Known contraindication for Jada System; ongoing intrauterin pregnancy, untreated uterine rupture, unresolved uterine inversion, current cervical cancer, unknown uterine anomoly, current purulent infection","44 Years",{"count":488,"type":22},424,[25],"This will be the first, definitive, randomized control trial (N=424) to test the hypothesis that the Jada® System is effective, safe and cost-effective in treating PPH, compared to standard care.",[492,493],"Postpartum Hemorrhage","Maternal Death","2023-12-14",{"date":496,"type":41},"2023-12-21",{"date":498,"type":41},"2023-10-23",{"date":500,"type":22},"2027-04-30",{"name":47,"class":48},2,{"id":504,"slug":505,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":17,"sex":98,"minAge":19,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":23,"phases":511,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":49},"100487306","phase-2-the-effect-of-intrawound-vancomycin-powder-on-surgical-site-infection-in-inguinal-lymph-node-dissection-100487306","NCT05625373","The Effect of Intrawound Vancomycin Powder on Surgical Site Infection in Inguinal Lymph Node Dissection","Inclusion Criteria:\n\n* Women who are undergoing inguinal lymph node dissection for vulvar dysplasia\n* Women with a prior lymph node dissection \\>30 days before\n* Women undergoing either a sentinel lymph node biopsy or full lymphadenectomy in a unilateral or bilateral groin dissection\n\nExclusion Criteria:\n\n* Known allergy to vancomycin\n* Known resistance to vancomycin",{"count":510,"type":22},30,[512,182],"PHASE2","The study will be a pilot randomized control trial with a 1:1 patient randomization of vancomycin powder placement at the time of surgery (compared to no vancomycin placement) with the goal of reducing postoperative complications in patients undergoing an inguinal lymph node dissection for vulvar cancer. The primary objective is to measure the composite rate of postoperative complications within 30 days of inguinal lymph node dissection in patients with vulvar cancer.",[515],"Postoperative Complications","2023-12-04",{"date":518,"type":41},"2023-12-05",{"date":520,"type":41},"2022-10-25",{"date":522,"type":22},"2024-08-30",{"name":47,"class":48},""]