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167 active trials for Pregnancy

Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial

This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period

Start: October 2010

Longitudinal Study of Intra-Uterine Growth Restriction

The investigation will employ a longitudinal approach in which every fetus diagnosed to be SGA (Small for Gestational Age ) will be studied at frequent intervals with sophisticated imaging techniques to assess subtle physiologic changes in the brain, heart, and placenta over time. These findings will be correlated with neurological and cardiovascular function in the newborn and early childhood. This research initiative should yield diagnostic and therapeutic templates that will improve the quality of life of IUGR babies in addition to providing important information that will better inform current diagnostic practices.

Start: April 2015

Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation

The purpose of the study is to test whether nutritional supplementation during pregnancy is associated with 1) improved maternal health during pregnancy; 2) improved infant birth and neurodevelopmental outcomes, and 3) whether the association between nutritional supplementation during pregnancy and infant outcomes is partially mediated by reductions in maternal perceived stress and stress reactivity during pregnancy.

Start: January 2016

Study of Placental Function in Healthy and Pathological Pregnancies

The purpose of this study is to establish a tissue and data repository consisting of samples of human placentas, umbilical cord blood, and maternal blood, collected at the time of delivery. Specimens will be used in cellular, molecular, and functional studies to learn more about changes in placental structure and function, which can result in serious pregnancy complications and determine life-long health by programming the fetus for future metabolic and cardiovascular disease.

Start: September 2014

The Early and Late Contribution of Fasting and Postprandial Triglycerides on Newborn Subcutaneous and Intrahepatic Fat in Pregnancy

This study plans to learn more about how triglyceride levels in pregnancy affect newborn fat mass. Obesity in pregnancy, in the absence of gestational diabetes, is now the most common cause of large-for-gestational-age infants and increased newborn fat mass. Previous data supports the idea that maternal triglycerides, not glucose, are the strongest predictor of both total newborn fat mass and liver fat. In this study, mothers will monitor triglyceride and glucose levels at specific points in pregnancy using point-of-care meters at home. Two weeks after birth, infants will have total fat measured by air-displacement plethysmography (PEAPOD) and liver fat measures by Magnetic Resonance Spectroscopy (MRS). The central hypothesis is that in obesity, fasting triglycerides and postprandial triglycerides will predict newborn fat mass in a free-living environment.

Start: September 2021

Pilot RCT: Remote SBIRT Vs. In-Person SBIRT

The goal of this work is to develop an effective remote mental health and substance use Screening, Brief Intervention and Referral to Treatment (SBIRT) program for pregnant and postpartum women. The present study will conduct a pilot RCT of of a text-message based SBIRT and home-based telemedicine services for pregnant and postpartum women - called Listening to Women (LTW), compared to treatment as usual (TAU).

Start: December 2020

Fetal Programming of Obesity

The overall goal of this project is to understand how a mother's health at conception may influence her child's growth and development.

Start: April 2010

Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia

The purpose of this study is to learn if giving 17-hydroxyporgesterone caproate (17 OHPC) to mothers with preeclampsia diagnosed before 34 weeks gestation improves mother and baby outcomes.

Start: May 2017

Observational Maternal COVID-19 Vaccination Study

This is a prospective, observational study. During the study, pregnant women will be followed post COVID-19 vaccination. Injection-site (local) and systemic reaction data will be assessed on vaccination day and during the 8 days following the second vaccination using either identical web-based or paper diaries, depending on study participant preference. Maternal serum samples will be collected for antibody titers relevant to COVID-19 at time points that include: prior to vaccination, ~29 days post second vaccination, and at delivery. At Duke University, maternal and infant cord blood will be collected at delivery and analyzed for the same antibody titers. At other clinical sites, these delivery samples will only be collected if feasible. Pregnant women will be followed through 90 days postpartum. with comprehensive obstetric and neonatal outcomes obtained from medical record review.

Start: May 2021

EOS® Versus Spiral CT Technique for Achieving a Pelvimetry in Suites of Obstructed Labor.

The aim of this study is to demonstrate in vivo the concordance of the imagery system EOS and the spiral CT in women having had an obstructed delivery. If this concordance is demonstrated, it would allow the use of this new technique of imagery, to realize a pelvimetry during the pregnancy less irradiating for the mother, and the fetus.

Start: May 2016

Labor Induction With Oral Versus Vaginal Misoprostol

This study will compare vaginal and oral misoprostol, to determine whether a vaginal misoprostol regimen achieves a higher vaginal delivery rate in a real-world, high-volume setting, and whether this regimen reduces time and oxytocin need on a high-volume Labor and Delivery unit at Parkland Hospital. Our primary hypothesis is that among women with singleton, term pregnancies, cervical dilation 2cm or less, and indicated labor induction, the rate of vaginal delivery is significantly increased when a standardized vaginal misoprostol regimen is used, compared with a standardized oral misoprostol regimen.

Start: May 2021

Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy

This study will evaluate maternal tolerance to several BUP dose reduction strategies.

Start: April 2019

A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor

The purpose of this study is to study if misoprostol administered orally is at least as effective as misoprostol administered vaginally for cervical ripening and the induction of labor. The main purpose is to show that oral misoprostol administration is non-inferior to vaginal misoprostol administration with respect to the time interval from misoprostol administration to onset of active phase of labor. The study is a non-inferiority, prospective randomized controlled trial comparing oral misoprostol given as 25 mcg every 2 hours versus vaginal misoprostol given as 25 mcg every 4 hours.

Start: November 2017

Impact of Pregnancy on Buprenorphine Pharmacokinetics and Pharmacodynamics

The primary purpose of this study is to determine whether buprenorphine and metabolite exposure (reflected as the dose-adjusted plasma concentration x time curve [AUC]) differs during pregnancy and between pregnancy and the postpartum state.The study will define the pharmacokinetics of buprenorphine and determine if there is a better way to gauge dosing based on objective, physiological parameters of satiety. The study will define neonatal exposure to buprenorphine through breast milk.

Start: August 2016

Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE)

The primary objective of this study is to compare the efficacy and safety of vaginal and buccal misoprostol for women undergoing labor induction at greater than or equal to 37+ 0 completed weeks gestation. Thus, the investigators have both efficacy and a safety primary outcomes. The secondary objective of this study is to assess the pharmacokinetic(PK) parameters with these two routes of administration in a sub-cohort of this trial. The long term objective of this line of research is to inform providers' clinical decision making for the large number of women having labor induction. By providing robust PK and pharmacodynamic (PD) evaluation, clinical outcomes data for these two routes of administration, clinicians will be informed for evidence-based decisions about the preferred route of administration of misoprostol.

Start: September 2015

Personalized Prevotella sp. and Butyrate Enriching Diet (PPBe)

The research aims to elucidate a specially-designed personalized diet that will increase gut colonization of Prevotella sp. and butyrate levels in pregnant mothers and the benefits in reducing infant's food allergy development.

Start: July 2021

Group Versus Traditional Prenatal Care for Diabetes

The investigators primary objective is to conduct a randomized trial to determine the effect of diabetes group prenatal care on glycemic control and postpartum weight retention in women with type 2 diabetes and gestational diabetes.

Start: September 2017

Targeted Lifestyle Change Group Prenatal Care

To conduct a randomized trial to determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal and neonatal outcomes in women at high risk for developing gestational diabetes mellitus (GDM).

Start: November 2019

bAriatric sUrgery Registration in wOmen of Reproductive Age

The use of bariatric surgery has risen subsequently over the last decade, especially in women of reproductive age. (Unplanned) pregnancies in this subgroup are not rare because of e.g. an increased fertility (because of the weight loss) and a possible ineffectiveness of contraceptives (because of a malabsorption in the intestine). Although a pregnancy after bariatric surgery is generally known as safe, there are a few studies that indicate that a pregnancy after a bariatric surgery is not always without complications, and that it should be considered as a high risk pregnancy. The research on pregnancy outcomes after this type of surgery is rather limited to a few small, mainly retrospective, observational case-control and cohort studies and a limited amount of case studies. For risk- and prognose related issues, e.g. the effect of bariatric surgery on fertility, timing of the pregnancy, development of complications during the pregnancy and pregnancy outcomes, large prospective cohort studies are needed. Besides, breast feeding practices and breast milk composition have scarcely been investigated in this population. The energy content of breast milk could possibly be influenced by a state of malabsorption after the procedure. Low amounts of vitamin B12 have also been noticed in the breast milk of women the surgery. The overall objective of this study is to establish a group of women at reproductive age (age 18-45) with a history of bariatric surgery and to generate an extensive database for future analysis. The final goal of the researchers is to develop guidelines or recommendations on how to manage pregnancies after bariatric surgery, based on large-scale prospective research. The study design is a multicentric observational and prospective cohort study. Participants will be followed from the moment of surgery until 6 months postpartum and they can be included on several time points (before surgery, after surgery (<12 months); after surgery (>12 months) or during the pregnancy). Both retrospective and prospective data concerning the medical background, fertility (menstrual cycle), lifestyle (e.a. food, physical activities, smoking, sleeping), blood samples, psychological factors (fear and depression), sexuality, quality of life and pregnancy outcomes will be collected. Data collection by the investigators will happen in a web-based database and by direct online registration by the subjects.

Start: July 2012

Genomic and Epigenomic Alterations After Cancer Treatment in Pregnancy

The investigators want to obtain a fundamental understanding if and which chemotherapeutic agents used for treating cancer during pregnancy are associated with placental and/or offspring (epi)genetic changes, potentially causing FGR and childhood/adult diseases later in life.

Start: October 2019