Preeclampsia

Researchers are studying pregnant women to understand how microbiome, proteomics, and serum markers might help predict preeclampsia, a condition that can affect pregnancy. This multicenter, prospective cohort study also aims to explore how these biological markers relate to pregnancy outcomes such as complications during pregnancy, delivery, and the newborn's health. The study is conducted by Zhujiang Hospital and focuses on maternal and infant microecology in China. Pregnant women who come to the hospital before 14 weeks of gestation are invited to participate. After consenting, they will complete a questionnaire and provide samples including urine, serum, saliva, vaginal swabs, and feces at several points during pregnancy: 11-14 weeks, 22-28 weeks, 32-34 weeks, and at delivery. If possible, placenta, cord blood, and amniotic fluid will also be collected at delivery. Women with preeclampsia during pregnancy will be followed up with similar sampling up to two years after their child is born. Participants will be monitored through various laboratory assessments including 16S rRNA gene sequencing for microbiome analysis and advanced techniques like MALDI-TOF peptidomics and mass spectrometry metabonomics. The study will also evaluate patient-specific risk of preeclampsia using clinical measurements such as mean arterial pressure and serum placental growth factor. Follow-up visits after delivery will occur at 6 weeks, 6 months, 1 year, and 2 years to continue monitoring maternal and infant health. The primary outcomes include microbiome, proteomics, and metabonomics data collected over 34 months, with secondary outcomes assessed over 10 months.

Preeclampsia (PE) is a serious condition affecting 3-8% of pregnancies and is a leading cause of illness and death for mothers and babies. It involves high blood pressure and organ damage or growth problems in the fetus. There are two main types: placental PE, linked to problems with the placenta and early pregnancy complications, and metabolic PE, related to maternal metabolic issues like obesity and inflammation. Recent research suggests that changes in the mother's gut bacteria may influence the immune system and play a role in PE development. This study aims to better understand the gut microbiota differences in these two PE types to improve prediction and prevention. The study observes pregnant women from 11 to 13 weeks gestation who are either at high risk or low risk for developing PE based on early screening. Participants include women over 18 with a single pregnancy and a live fetus. Researchers will monitor maternal gut microbiota, metabolic markers, and immune system characteristics during the first trimester without providing any treatments. The study includes a control group of low-risk pregnancies followed throughout pregnancy to compare with the high-risk group. Participants will undergo assessments including gut microbiota analysis, metabolic profiling, and immune function tests during early pregnancy. Researchers will track outcomes related to PE development and fetal growth restriction, aiming to identify biomarkers that could help predict PE types. The study lasts about one year per participant, with data collected during pregnancy and after delivery. This observational study does not involve treatment but focuses on collecting detailed biological and clinical information to improve understanding of PE.

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 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 hospitalized women with preterm preeclampsia to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug called CBP-4888. This open-label dose-finding study focuses on pregnant participants between 26 and nearly 36 weeks gestation who are receiving standard care with expectant management. The study aims to find the appropriate dose and monitor outcomes for both mothers and their babies. During the study, eligible participants will receive a single subcutaneous injection of CBP-4888 on Day 1, with dosing based on the participant's first trimester weight. Up to 60 participants will be enrolled across six dose levels, with all receiving standard care alongside the study drug. Mothers will be closely monitored through delivery and for six weeks postpartum, while their infants will be followed for up to 24 months with regular pediatric assessments. Participants will be observed for treatment-related events and adverse effects through six weeks after delivery. Infants will undergo evaluations immediately after birth and continue with developmental assessments using the Ages and Stages Questionnaire up to two years of age. The study tracks drug levels in the blood, safety signals, and long-term developmental outcomes to understand the effects of CBP-4888 on both mothers and their children.

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.