Stillbirth

Researchers are evaluating how well symphysis fundal height (SFH) measurements alone compare to SFH combined with point of care ultrasound (POC-US) measuring fetal abdominal circumference (AC) for detecting small or large for gestational age infants among low-risk pregnant women after 35 weeks' gestation. The study aims to improve prenatal identification of abnormal fetal growth, which is linked to risks for mother and baby. This open-label, randomized trial is investigator-sponsored and focuses on low-risk pregnancies managed by midwives. Participants are randomly assigned to one of two groups: one group will have fetal growth monitored using SFH measurements alone, while the other will have SFH plus POC-US to measure fetal AC and assess amniotic fluid volume. Measurements occur at scheduled antenatal visits at 35-38, 40, 41, and beyond 41 weeks' gestation. If screening suggests abnormal growth or amniotic fluid levels, a formal obstetric ultrasound by a specialist will be performed. All women will have POC-US at 41 and 41+ weeks to check amniotic fluid, regardless of group. During the study, midwives will review medical histories, conduct physical measurements, and perform ultrasound assessments following the assigned method. Researchers will compare prenatal screening results to actual birth weights to identify small or large infants. They will also track the number of formal ultrasounds requested, cases of abnormal amniotic fluid, and maternal and neonatal outcomes. Participation lasts from enrollment at 35-38 weeks through delivery and initial postnatal assessment, about one year on average.

Researchers are exploring how giving pregnant individuals a choice among different nutrition and exercise programs affects their ability to stick to the program and maintain healthy pregnancy outcomes. The study focuses on preventing excessive gestational weight gain by comparing adherence to three lifestyle intervention strategies within the Nutrition and Exercise Lifestyle Intervention Program (NELIP). This research uses a pseudo-randomized design to examine if choice improves participation compared to no choice in pregnant individuals between 12 and 18 weeks of pregnancy with a single fetus. Participants are divided into two groups: one group chooses from three intervention strategies and the other group is matched to a choice participant and receives the same strategy without choice. The three strategies vary in timing of introducing nutrition and exercise components; either both simultaneously starting at 12-18 weeks, or nutrition first followed by exercise at 25 weeks, or exercise first followed by nutrition at 25 weeks. The exercise involves a supervised walking program with gradually increasing duration, and nutrition is based on a modified gestational diabetic meal plan tailored per participant. The full program continues until delivery, with final intervention measures between 34 and 36 weeks gestation. Participants will be monitored weekly for adherence using a point system, with additional assessments of satisfaction and health outcomes like weight gain, birth measurements, and pregnancy complications. Follow-up visits occur at birth and at 2, 6, and 12 months postpartum to track maternal and infant health. The study collects detailed data on nutrition, exercise, and pregnancy progress to understand how choice impacts adherence and outcomes over this extended timeline.

Researchers are studying how serum kisspeptin levels change throughout pregnancy in women with polycystic ovary syndrome (PCOS). This study aims to understand the relationship between kisspeptin, insulin, glucose, and testosterone levels, and to explore whether kisspeptin can predict gestational diabetes mellitus (GDM) and other pregnancy complications in PCOS patients. The study is observational and focuses on pregnancies affected by PCOS using the 2003 Rotterdam diagnostic criteria. The study includes two groups: pregnant women aged 18 to 40 diagnosed with PCOS before pregnancy, and healthy pregnant women in the same age range without PCOS. Participants will be registered for prenatal check-ups during the first trimester. This is an observational study, so no specific treatments or interventions will be given. Researchers will monitor kisspeptin and related hormone levels at different stages of pregnancy. Participants will be followed throughout pregnancy, with assessments to measure dynamic changes in serum kisspeptin over 40 weeks. The study will also evaluate how kisspeptin levels relate to the development of GDM and insulin resistance. Participants will undergo regular check-ups, laboratory tests, and hormone measurements. The study will help understand hormonal changes in PCOS pregnancies and their potential impact on complications, with a total participation time covering the full pregnancy period.

Researchers are studying the use of two new surgical devices, the Karl Storz Curved and Straight Fetoscopes, to assist in minimally invasive in-utero surgeries. These devices help surgeons see inside the uterus during procedures to treat fetal conditions like twin-twin transfusion syndrome and other complex anomalies. The study aims to assess surgical outcomes, complications, and gestational age in patients treated with these scopes, helping to understand their potential benefits in fetal surgery. The curved fetoscope is designed for patients with an anterior placenta, while the straight fetoscope is used for those with a posterior placenta. Both scopes assist in fetoscopic laser photocoagulation, a procedure that seals abnormal blood vessels in the placenta using laser energy. This research is a non-randomized, single arm study where eligible patients undergo intrauterine procedures with either the curved or straight scopes based on placenta position. The study will collect data on the success of the procedures and related complications for descriptive analysis. Participants will be monitored through the procedure and follow-up until birth and shortly after. The study will evaluate outcomes such as the rate of completed fetoscopic procedures, fetal survival at birth, and various maternal and fetal complications. Researchers will also track gestational age at delivery, procedure length, and short-term neonatal health. The total study duration extends over several years to capture both immediate and longer-term results of using these devices in fetal surgery.

This research aims to reduce Black-White maternal health disparities by using interventions to decrease bias in prenatal care, improve care coordination, and increase social support. Known as ACURE4Moms, this pragmatic 4-arm cluster randomized controlled trial involves 39 prenatal practices across North Carolina. The study focuses especially on reducing pregnancy complications and low birthweight deliveries among Black patients, who face higher risks related to institutional racism and discrimination. The study compares four groups: standard care with Medicaid care management for high-risk pregnancies; care management plus Data Accountability and Transparency interventions including electronic warning systems, disparities dashboards, and racial equity training; care management plus Community-Based Doula support providing culturally relevant care during pregnancy, labor, and postpartum; and a combination of both Data Accountability and Transparency and Doula Support interventions. Each practice participates for two years, initiating prenatal care for approximately 750 to 1,500 patients, with outcomes tracked through delivery and one year after birth. Participants include patients who self-identify as Black or African American receiving prenatal care at participating clinics. Researchers collect data from electronic health records on low birthweight and other pregnancy outcomes and gather patient experiences of discrimination through internet surveys at four time points from the first prenatal visit to three months postpartum. Additional interviews with staff, doulas, and facilitators help assess intervention fit. The study is led by a Stakeholder Advisory Board focusing on patient-centered outcomes and policy advocacy.

This research aims to develop a multi-level intervention called TENDAI4PrEP, adapted from the TENDAI program, to improve uptake and persistence of oral pre-exposure prophylaxis (PrEP) among pregnant persons in Zimbabwe. The study addresses the urgent public health need due to Zimbabwe's high HIV prevalence, especially among cisgender women of reproductive age, and aims to overcome barriers such as psychological distress, stigma, low partner support, and limited provider knowledge. The intervention involves 4-5 problem-solving sessions including one with a partner and an optional postpartum booster, incorporating PrEP education, psychoeducation, and a culturally adapted Life Steps approach. Participants are randomized to either the TENDAI4PrEP intervention or enhanced treatment as usual (ETAU), which includes monthly antenatal care visits and educational pamphlets. Providers at the clinics also receive training to improve PrEP knowledge and reduce stigma. Participants will be involved in assessments over approximately five months post-baseline, including evaluations of feasibility and acceptability of the intervention and provider training. Measurements include self-reported PrEP adherence, psychological distress, PrEP persistence, and changes in provider knowledge and stigma. Qualitative interviews with providers and administrators will explore implementation outcomes to prepare for larger-scale testing.

This research aims to evaluate a new advanced wireless skin sensor system designed to monitor vital signs in healthy newborn infants of at least 35 weeks gestational age. The study focuses on assessing the feasibility, safety, and accuracy of this wireless system compared to the standard wired monitoring during the first two hours after birth, especially during unsupervised parental care in the obstetrical center. The goal is to improve early detection and prevention of Sudden Unexpected Postnatal Collapse (SUPC), a rare but serious condition affecting newborns shortly after delivery. Participants will have both the wireless monitoring system and the standard wired system placed on their chest and limb. For vaginal births, the wireless system is placed first, followed by the wired system after 15-20 minutes; for C-section births, the order of placement is randomized. Both monitoring systems remain in place for two hours to continuously record vital signs such as heart rate, respiratory rate, oxygen saturation, and skin temperature. During the study, newborns' vital signs will be recorded and compared between the two systems for up to two hours immediately after delivery. Researchers will evaluate the feasibility by checking for gaps in data and user satisfaction, assess safety through skin and pain scores, and measure accuracy using statistical comparisons. The study also includes monitoring the time between sensor placement and data display. Participation lasts only the initial two-hour period after birth, with monitoring done under real-world conditions in the obstetrical center.

Researchers are evaluating the use of the Femom device, a non-invasive fetal ECG tool designed for self-application and remote monitoring, to track fetal heart rate in both low and high-risk pregnancies. The study aims to determine if remote recordings from Femom provide reliable information about the baby's heart rate and to establish reference standards for heart rate variability during uncomplicated pregnancies at various stages. It will also compare heart rate variability in pregnancies affected by fetal growth restriction (FGR) and insulin-dependent diabetes to normal pregnancies. Participants are divided into three groups: low-risk controls, FGR pregnancies, and insulin-dependent diabetic pregnancies. Women in the control group will monitor their baby's heart rate once a day for one week. Those in the FGR group will monitor daily until delivery, while women with insulin-dependent diabetes will monitor daily from 36 weeks until delivery. Data collected will be analyzed to assess participant adherence, signal quality, and heart rate variability, along with usability feedback from questionnaires. During the study, participants will monitor their baby's heart rate at home using the Femom device. Researchers will collect and analyze fetal heart rate (FHR) and maternal heart rate (MHR) recordings over 60-minute periods. The study will also gather feedback on the device's ease of use and monitor pregnancy outcomes. Participants' involvement duration varies by group, with ongoing monitoring until delivery for high-risk groups. The study is observational and led by Biorithm Pte Ltd.

Researchers are studying fetuses with severe kidney failure that causes very low amniotic fluid, a condition called anhydramnios. This lack of fluid can harm lung development and lead to serious health problems or death shortly after birth. The study aims to find out if repeated amnioinfusions, which add fluid to the amniotic sac, can improve survival chances until dialysis or kidney transplant is possible. This research builds on earlier findings and seeks to improve outcomes for families facing this diagnosis. Participants will be divided into two groups: one receiving serial amnioinfusions with routine care, and a control group receiving comfort care without intervention. The amnioinfusions involve injecting sterile fluid into the amniotic cavity using a thin needle guided by ultrasound. The study team will perform these procedures at a specialized fetal care center, adjusting the number of infusions as needed. The trial also includes careful safety monitoring throughout pregnancy and after delivery. During the study, participants will have regular imaging tests like ultrasounds, echocardiograms, and MRIs, along with lab tests to monitor both the fetus and mother. Researchers will track fetal survival to dialysis and transplant, maternal safety up to 30 days after birth, and other pregnancy outcomes such as timing of membrane rupture and delivery. Follow-up will continue until at least two years after birth to assess transplant eligibility and long-term survival.

Thick meconium in the amniotic fluid occurs in about one out of seven pregnancies and can increase the chance of breathing problems for newborns, such as needing oxygen or breathing support, NICU admission, or severe issues like meconium aspiration syndrome or persistent pulmonary hypertension. Previous studies on amnioinfusion—a procedure that places sterile fluid into the uterus during labor—had limitations like varied meconium types and inconsistent protocols. This trial aims to determine if a modern, standardized warm lactated Ringer's (LR) amnioinfusion can reduce newborn respiratory problems when thick meconium is present. Participants who are at least 36 weeks pregnant with confirmed thick meconium-stained amniotic fluid will be randomly assigned to either receive a warm LR amnioinfusion through an intrauterine pressure catheter or standard care without amnioinfusion. The intervention involves a 500 mL bolus of warmed LR infused over 30 minutes, followed by a maintenance infusion until the fluid clears or delivery occurs. Ultrasound checks and infusion details are recorded to ensure the procedure follows a strict protocol. During the study, researchers will collect umbilical cord blood at birth to measure inflammation and brain injury markers. They will monitor newborn respiratory health for 72 hours, including oxygen needs, breathing support, NICU admission, and other complications. Families will be contacted when the child is 12 months old to complete a developmental questionnaire. The trial also tracks longer-term respiratory and healthcare outcomes, aiming to provide strong evidence for care during labor when thick meconium is present.