HELLP syndrome is a serious pregnancy-related condition characterized by hemolysis, elevated liver enzymes, and low platelet count, requiring careful clinical management. Clinical trials for HELLP syndrome often evaluate treatment approaches aiming t...

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Found 94 Actively Recruiting clinical trials

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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.

Age: 18Years - 40YearsFEMALE
1 location
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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.

Age: 18Years +FEMALEPhase Not Applicable
1 location
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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.

Age: 18Years +FEMALEPhase 4
1 location
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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.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Pregnancy increases the risk of developing blood clots by nearly five times, which can be dangerous for both mother and baby. Researchers are studying whether giving the medication Lovenox three times a day instead of the usual twice daily can help maintain more consistent blood levels and potentially reduce this risk. This study focuses on pregnant women who need therapeutic low molecular weight heparin to prevent clots during pregnancy. Participants in this study will receive Lovenox split into three doses per day for five days. The researchers will measure Factor Xa levels, an indicator of how well the medication is working, four hours after injection. This dosing schedule is being tested because changes in blood volume and kidney function during pregnancy may affect how the medication is processed. During the study, women will have their blood tested to check Factor Xa levels after each Lovenox injection. The study team will monitor these levels to understand how three times daily dosing affects medication consistency. Participation includes regular visits over the treatment period, and the research aims to gather detailed information on the medication's anticoagulation profile in pregnant women.

Age: 18Years +FEMALEPhase 4
1 location
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Researchers are studying postpartum pulmonary artery pressure in women who experienced preeclampsia during pregnancy, focusing on those with and without obstetric antiphospholipid syndrome (oAPS). The study aims to understand if the combination of preeclampsia and oAPS increases the risk of long-lasting pulmonary hypertension. This observational study is conducted at a single center and follows women up to three years after delivery to explore cardiovascular outcomes and risks. Women in two groups—those with preeclampsia and oAPS, and those with preeclampsia without oAPS—are followed for three years postpartum. During this period, routine data including echocardiography images and 24-hour ambulatory blood pressure monitoring are collected. These diagnostic tests assess heart function and blood pressure to compare outcomes between the groups. Participants will undergo scheduled evaluations including clinical exams, echocardiography, blood pressure monitoring, and blood sampling. Researchers will analyze changes in systolic pulmonary artery pressure and systemic arterial blood pressure at three months and three years after delivery. The study also seeks to assess the prevalence of arterial hypertension and develop prediction models for cardiovascular risks in women who had preeclampsia. Data collection will continue through 2028, covering retrospective and prospective follow-up periods.

Age: 16Years +FEMALE
1 location
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Healthy Volunteer

Pregnancy-related death rates have significantly increased in the United States over the past two decades, with many cases considered preventable. This research focuses on improving awareness and decision-making among postpartum patients, especially African American and Spanish-speaking Latina women, to help them recognize warning signs and seek timely medical care. The study evaluates a mobile health approach designed to support these patients in self-monitoring symptoms and receiving guidance on when to seek help. Participants will use the Maternal Outcome Monitoring and Support (MOMS) system, a smartphone application that allows them to report symptoms related to pregnancy complications. The app provides decision support to help users decide when to contact their healthcare provider or visit an emergency room. This single-arm pilot trial assesses the feasibility and early impact of this intervention in improving patient knowledge and activation during the postpartum period. During the study, participants will engage with the MOMS app from baseline through six weeks postpartum, with researchers measuring changes in patient activation and knowledge of pregnancy-related death warning signs. The study will monitor participants remotely through the app, collecting patient-reported outcomes to evaluate how well the system supports timely care-seeking behavior. This involvement aims to improve postpartum health outcomes in diverse populations facing disparities.

Age: 18Years +FEMALEPhase Not Applicable
2 locations
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Researchers are investigating whether using the automated insulin delivery system CamAPS FX during pregnancy planning or early pregnancy can improve blood sugar control and fetal growth in women with type 1 diabetes. This national multi-center open-label randomized controlled trial compares the CamAPS FX system to usual insulin treatment methods combined with continuous glucose monitoring. The study focuses on women aged 18 to 45 with type 1 diabetes who are planning pregnancy or are in early pregnancy. Participants will be randomly assigned to either start using the CamAPS FX automated insulin delivery system or continue their usual insulin treatment with continuous glucose monitoring. Women planning pregnancy will begin their assigned treatment before conception and continue throughout pregnancy until one month after delivery, or for up to 52 weeks if they do not become pregnant. Those pregnant at the start will follow their assigned treatment until one month post-delivery. During the study, participants will be closely monitored through continuous glucose data, insulin and carbohydrate tracking, blood tests including HbA1c, and fetal growth assessments via ultrasound. Researchers will evaluate time spent in target blood sugar range and birthweight as primary outcomes, along with various secondary measures such as pregnancy and birth complications, neonatal health, and maternal weight. The study lasts until one month after delivery or up to 52 weeks for those not becoming pregnant, with ongoing safety and health assessments.

Age: 18Years - 45YearsFEMALEPhase Not Applicable
8 locations
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Pregnancy raises the risk of blood clots and complications related to the placenta, which can cause serious health issues for both mother and baby. Researchers are studying the balance between autophagy (cell maintenance) and apoptosis (cell death) in the placenta to better understand how these processes may contribute to placental vascular diseases like preeclampsia and intrauterine growth retardation. This study builds on previous research that looked at these cell activities in normal pregnancies. The study involves pregnant women who develop placental vascular complications and are hospitalized at Nimes University Hospital. Blood and urine samples will be collected at the start, then monthly during pregnancy follow-up visits, and again at delivery. These samples will be tested to measure specific proteins related to autophagy and apoptosis, as well as other markers linked to vascular and kidney function. Participants will undergo regular monitoring through blood and urine tests to track changes in cell activity and other biological markers from the start of the study until delivery. Researchers will analyze these samples to understand the cellular mechanisms involved in the placental complications. The study aims to provide new insights that could lead to better screening and prevention strategies for these pregnancy-related vascular problems.

Age: 18Years +FEMALE
1 location
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Healthy Volunteer

Researchers are studying how different immune cells interact with placental cells and how this interaction may lead to pregnancy complications, especially focusing on preeclampsia. The study aims to understand how uteroplacental syndrome develops into maternal symptoms in preeclampsia by examining immune cell subtypes that cause endothelial dysfunction and cardiovascular damage during pregnancy. This observational study includes healthy pregnant women as well as those diagnosed with preeclampsia, gestational hypertension, or gestational diabetes. Participants will be observed without receiving experimental treatments. The study focuses on comparing immune cell populations, particularly T cells, at the time of preeclampsia diagnosis to those in control pregnancies. Participants will undergo evaluations including flow cytometry to measure T cell populations during pregnancy. Researchers will collect data at the time of preeclampsia diagnosis and compare it with controls at the same gestational stage. The study is sponsored by Charite University in Berlin and includes women aged 18 to 45 years. The total participation duration varies by the timing of diagnosis and pregnancy progress.

Age: 18Years - 45YearsFEMALE
1 location

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