Fetal Growth Restriction

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 establishing a multicenter cohort study focusing on placenta-mediated fetal growth restriction (FGR), specifically maternal vascular malperfusion-related FGR (MVM-FGR). This condition involves the fetus not reaching its genetic growth potential due to various pathological factors, and it is linked to significant health risks during and after pregnancy. The study aims to identify early and long-term indicators of adverse outcomes related to MVM-FGR to improve intervention and prevention strategies. The study enrolls singleton pregnancies diagnosed with MVM-FGR based on strict diagnostic criteria aligned with the FIGO consensus. Participants undergo prenatal screenings for genetic abnormalities, infections, and structural anomalies. Techniques such as Doppler ultrasound, magnetic resonance imaging (MRI), and electronic fetal heart monitoring are used to assess fetal health. After delivery, the placenta is examined pathologically, with genetic testing performed if needed. The follow-up period extends until the child reaches two years of age. Participants will be monitored throughout pregnancy and postpartum to collect detailed data on fetal and maternal health. Researchers will track short-term and long-term outcomes associated with MVM-FGR, including mortality during pregnancy and within 28 days after birth. They will also study genetic causes of FGR and maternal complications after 28 days postpartum. This comprehensive monitoring includes imaging, genetic testing, and clinical assessments to build a predictive model for adverse outcomes.

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 the effects of living at high altitude during pregnancy by following two groups of healthy pregnant women: one group residing at elevations above 3,500 meters and another residing at sea level. The study aims to understand how chronic low oxygen levels at high altitudes affect heart function, especially the right side of the heart, fetal growth, and the role of nitric oxide in pregnancy complications related to blood vessel and heart function. The study involves detailed heart ultrasound examinations to assess right heart anatomy and function, including measurements of pulmonary artery pressure and right ventricular performance. Researchers will also track fetal growth before and after birth, examine placental characteristics, and measure nitric oxide-related substances in maternal blood, umbilical cord blood, and placental tissue. These assessments will be correlated with oxygen levels and altitude exposure. Flow-mediated dilation tests will be performed in the high altitude group to evaluate blood vessel function. Participants will be monitored through late pregnancy (around 35 weeks) and into the postpartum period (about 6 weeks after delivery). Researchers will collect data on heart and fetal measurements, nitric oxide levels, and birth weight. This comprehensive monitoring aims to clarify how high altitude impacts cardiovascular health and fetal development during and after pregnancy, with ongoing follow-up until postpartum.

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.

Researchers are evaluating postpartum diabetes screening methods and cardiovascular health counseling for individuals who experienced gestational diabetes during pregnancy. The study compares immediate inpatient postpartum oral glucose tolerance testing (OGTT) before hospital discharge to the current standard outpatient OGTT performed 4-12 weeks after delivery. Additionally, the study explores patient perspectives on postpartum cardiovascular health counseling and risk reduction, including social and structural factors that affect health outcomes. This research is conducted to address the increased risk of type 2 diabetes and cardiovascular disease in this population and to improve postpartum care. The trial includes two study groups: one receiving an immediate inpatient 2-hour OGTT before discharge, and the other receiving the standard 4-12 week outpatient OGTT. Eligible participants are individuals aged 18 or older, diagnosed with gestational diabetes during pregnancy, and receiving prenatal and postpartum care at the study site. A follow-up phase involves surveys and qualitative assessments between 12 and 24 months postpartum to evaluate barriers and facilitators of cardiovascular health counseling and wellness interventions. Participants will undergo diabetes screening either immediately postpartum or during the standard postpartum visit, with data collected on screening rates up to 12 weeks after delivery. Patient-reported outcomes on cardiovascular health counseling will be gathered within 12 months postpartum, while patient perspectives on postpartum interventions will be assessed between 12 and 24 months postpartum. The study measures include diabetes screening rates, cardiovascular counseling experiences, lifestyle changes, primary care visits, and diabetes treatment satisfaction. This research helps identify ways to improve postpartum screening and cardiovascular health management for individuals with gestational diabetes.

Researchers are evaluating the use of dapagliflozin to reduce cardiovascular risk in women who have experienced hypertensive pregnancies. This randomized, placebo-controlled trial focuses on patients at high risk for adverse cardiovascular outcomes within five years after delivery. The study is a pilot-scale, single institution investigation aiming to assess the feasibility, acceptability, and effects of dapagliflozin during the postpartum period. Participants will be randomly assigned to one of two groups: one group will receive dapagliflozin 10 mg daily for six months, while the other group will receive a daily placebo for the same duration. During the study, participants will attend four study visits and complete specific activities including daily blood pressure monitoring, weekly weight measurements, laboratory tests, and echocardiograms. After the six-month treatment period, participants will be followed remotely for one month. Throughout the trial, researchers will measure cardiovascular risk reduction scores at the start and after six months of treatment. Secondary outcomes include tracking patient adherence, barriers to adherence, loss to follow-up rates, and screening statistics over a two-year recruitment period. The total participation includes treatment and follow-up visits, with regular assessments to monitor health and gather data for evaluating the study drugs' impact on cardiovascular risk.

Researchers are studying the effects of growth hormone treatment on cognitive development and growth in infants born small for gestational age (SGA) who have not caught up in height or head circumference by the age of 6 months to 2 years. This study aims to evaluate whether early treatment with PEG-rhGH can improve IQ, behavior, and self-cognition in these children, as well as promote catch-up growth, especially during the critical developmental period before age two. Participants are assigned either to a treatment group receiving PEG-rhGH injections at an initial dose of 0.2 mg/kg once weekly by subcutaneous injection at bedtime for 104 weeks, with dosage adjustments based on IGF-1 levels, or to a control group that receives no treatment but undergoes the same follow-up assessments over the 104-week period. This non-randomized study compares growth and cognitive development outcomes between these two groups. Throughout the study, children will be monitored regularly for growth parameters including head circumference and height, as well as cognitive, motor, social, and behavioral development using standardized scales like the Griffiths mental development scale and the Achenbach children’s behavior scale. The study also evaluates brain structure and function through imaging and metabolic assessments, and safety is closely tracked over the two years of participation.

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.