Clinical trials: Birth Outcomes, Adverse
Gestational Diabetes Mellitus (GDM)
Implementation and Evaluation of Bump2Baby and Me+ Programme for Gestational Diabetes Mellitus in Routine Maternity Care Setting.
Gestational diabetes mellitus (GDM) affects approximately 1 in 7 pregnancies globally and is associated with significant short and long-term health consequences for both mothers and infants.
- Trial name
- B2B&ME+ (NCT07189221)
- Testing
- Life Style Intervention
- Volunteers
- 3,600 people
- Sponsor
- University College Dublin
Pulmonary Arterial Hypertension, Air Pollution
The Risk of Adverse Pregnancy Outcomes for Long-term Exposure to Air Pollution in Pregnant Patients With Pulmonary Hypertension
With economic development and rapid urbanization, air pollution has become an increasingly severe public health concern. The risk of adverse pregnancy outcomes is significantly elevated for pregnant women complicated by pulmonary…
- Conditions
- Pulmonary Arterial Hypertension, Air Pollution, Maternal Outcome
- Trial name
- NCT07164157
- Where
- China
- Volunteers
- 1,200 people
- Sponsor
- Wei Huang
Adverse Maternal and Neonatal Outcomes
The Labor and Delivery Teamwork Intervention Trial
A cluster-randomized controlled trial was conducted at 7 intervention and 8 control hospitals to evaluate the effect of teamwork training on the occurrence of adverse outcomes and processes of care in labor and delivery.
- Trial name
- NCT00381056
- Testing
- Labor and Delivery Team Coordination Course
- Where
- 15 sites in United States
- Volunteers
- 30,000 people
- Sponsor
- Beth Israel Deaconess Medical Center
Maternal Complications, Pregnancy Complication
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their infant up to 12 months of life.
- Conditions
- Maternal Complications, Pregnancy Complication, Birth Outcomes, Adverse, Pregnancy
- Trial name
- NCT06113237
- Testing
- Epidiolex
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 50 people
- Sponsor
- Jazz Pharmaceuticals
Sexually Transmitted Infection, HIV/AIDS
Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes (Philani Ndiphile)
This study aims to evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) among pregnant women, and reduce adverse birth outcomes.
- Conditions
- Sexually Transmitted Infection, HIV/AIDS, Cost-effectiveness, Birth Outcomes
- Trial name
- NCT04446611
- Testing
- First antenatal care + test-of-cure, First antenatal care + week 30-34 gestation (no test-of-cure)
- Where
- South Africa
- Volunteers
- 2,247 people, healthy volunteers welcome
- Sponsor
- Foundation for Professional Development (Pty) Ltd
Birth Outcomes, Safety
Simultaneous mRNA COVID-19 and IIV Vaccination in Pregnancy Study
This study is a prospective, randomized clinical trial. During this study, pregnant women will be randomly assigned to receive IIV and mRNA COVID-19 vaccine either simultaneously or sequentially (7-14 days apart).
- Conditions
- Birth Outcomes, Safety, Adverse Event Following Immunization
- Trial name
- NCT06503900
- Testing
- mRNA COVID-19 vaccine, IIV4 (quadrivalent inactivated influenza vaccine)
- Where
- 6 sites in United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Duke University
Twin; Pregnancy, Affecting Fetus or Newborn
Birth Weight-discordance in Twins Pregnancy: a Multicenter Retrospective Study
The rate of twin pregnancies in China has increased by 50 percent over the past decade and now stands at about 3 percent. This is significantly higher than the European and American countries.
- Trial name
- NCT05674214
- Where
- China
- Volunteers
- 13,440 people, healthy volunteers welcome
- Sponsor
- The Third Affiliated Hospital of Guangzhou Medical University
Heart Failure With Preserved Ejection Fraction (HFPEF)
Association of Heterogeneous Circulating Biomarkers and Anamnestic Factors of Pregnancy Adverse Course and Outcomes With the Prognosis of Heart Failure With Preserved Ejection Fraction
The primary purpose of this study is to evaluate possible association of some heterogeneous circulating biomarkers and anamnestic factors of pregnancy adverse course and outcomes with the prognosis of heart failure with preserved…
- Trial name
- CARPO-HF (NCT06803849)
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- National Medical Research Center for Therapy and Preventive Medicine
Birth, First, Birth Outcome, Adverse
Reducing Turkey High Cesarean Section Rates
Considering the increasing rates of cesarean delivery in Turkey, we aimed to research the impact of antenatal education on pregnancy, the childbirth process, the cesarean section rate, and the postpartum period through a…
- Conditions
- Birth, First, Birth Outcome, Adverse, Breast Feeding
- Trial name
- NCT07799545
- Testing
- Antenatal education
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Saglik Bilimleri Universitesi
Birth Outcome, Adverse, Labor Long
How Long Can Labor Last? Person Centred Care During Labor to Increase Safety for Women and Newborn
"How long will my labor last" is a very common question for midwives who care for women during birth. To evaluate safe labor duration largely determines management and care during birth.
- Conditions
- Birth Outcome, Adverse, Labor Long, Labor Complication, Maternal Injury
- Trial name
- NCT06420453
- Where
- Sweden
- Volunteers
- 300,000 people
- Sponsor
- Karolinska Institutet
Safety, Adverse Event Following Immunisation
Safety of RIV4 Versus IIV4 in Pregnant Women
This is a prospective, randomized clinical trial. During the study, pregnant women will be randomized (1:1) to receive RIV4 or IIV4. Vaccines will be administered by licensed providers.
- Conditions
- Safety, Adverse Event Following Immunisation, Birth Outcomes
- Trial name
- NCT03969641
- Testing
- Quadrivalent Recombinant Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccine
- Where
- 3 sites in United States
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Duke University
Malaria in Pregnancy
Intermittent Preventive Treatment With Dihydroartemisinin-piperaquine in Papua, Indonesia
Malaria in pregnancy is a major cause of maternal and neonatal death in Papua, Indonesia. A recent trial in Papua showed that monthly intermittent preventive treatment (IPTp) with the long-acting artemisinin-based combination…
- Trial name
- STOPMiP-2 (NCT05294406)
- Testing
- Intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin-piperaquine
- Where
- Indonesia
- Volunteers
- 2,128 people, healthy volunteers welcome
- Sponsor
- Liverpool School of Tropical Medicine
Preterm Birth, Distress Respiratory Syndrome
Adverse Neonatal Outcomes With a Shortened Clinical Regimen of Dexamethasone.
Respiratory morbidity, including respiratory distress syndrome (RDS), is a serious complication of preterm birth and the leading cause of early neonatal mortality and disability.
- Trial name
- UNODEXA (NCT06569251)
- Testing
- Dexamethasone 12 mg QD, Dexamethasone 6 mg BID
- Where
- Honduras
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
Environmental Exposure, Fertility
JiGenerations Health Cohort Study：Parental Exposure and Intergenerational Health in China
The growing recognition of maternal health's impact on offspring necessitates large-scale prospective cohort studies spanning the maternal-child life cycle.
- Conditions
- Environmental Exposure, Fertility, Health Problems in Pregnancy, Adverse Pregnancy Outcomes
- Trial name
- NCT07514377
- Testing
- N/A (Observational Study)
- Where
- China
- Volunteers
- 100,000 people, healthy volunteers welcome
- Sponsor
- National Research Institute for Family Planning, China
Birth Outcomes, Labor and Delivery
Limiting Adverse Birth Outcomes in Resource-Limited Settings
The primary objective of this research is to exhaustively document the course and outcomes of hospitalization, labor, delivery, and early postpartum course of up to 15,000 mother-newborn pairs in settings where the occurrence of…
- Conditions
- Birth Outcomes, Labor and Delivery, Respiratory Infection
- Trial name
- LABOR (NCT04102644)
- Testing
- Observation
- Where
- 4 sites in Ghana, India and 1 more
- Volunteers
- 12,020 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Metabolic Syndrome, Pregnant Women
Progression of Metabolic Syndrome Components During Pregnancy
The goal of this cohort study is to investigate the underlying risk factors to develop metabolic syndrome (MetS) during pregnancy, and the associations of MetS and its indicators with birth outcomes in southwest Ethiopia.
- Conditions
- Metabolic Syndrome, Pregnant Women, Birth Outcomes, Dietary Habits
- Trial name
- MetS_Preg (NCT05935904)
- Testing
- Exposure, Non exposure
- Where
- Ethiopia
- Volunteers
- 526 people, healthy volunteers welcome
- Sponsor
- University Ghent
Alcohol Drinking
Reducing Alcohol Exposed Pregnancies
The goal of this clinical trial is to compare an active intervention versus a standard of care control in reducing alcohol use among pregnant women.
- Trial name
- NCT05766761
- Testing
- Intervention condition, the usual prenatal care plus the alcohol intervention
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- New York University
Fetal Growth Restriction (FGR), Preterm Birth
Enhancing Prediction of Adverse Pregnancy Outcomes in Africa Through Partnerships and Innovation
Pregnancy complications such as pre-eclampsia (high blood pressure during pregnancy), poor fetal growth, unexplained stillbirth, and spontaneous preterm birth are major causes of illness and death for mothers and babies in…
- Conditions
- Fetal Growth Restriction (FGR), Preterm Birth, Still Births, Abruptio Placentae
- Trial name
- EPAPOA (NCT07844876)
- Where
- 2 sites in Uganda
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- Makerere University
Cardiovascular Diseases
Continuation of the nuMoM2b Heart Health Study
Cardiovascular disease (CVD) is the leading cause of mortality and morbidity in U.S. women at all ages, and large knowledge gaps exist in CVD predictive and preventative strategies for women.
- Trial name
- nuMoM2b-HHS2 (NCT05472597)
- Where
- 14 sites in United States
- Volunteers
- 4,048 people, healthy volunteers welcome
- Sponsor
- RTI International
Pregnancy, Premature Birth
A Trial of Micronutrients and Adverse Pregnancy Outcomes
The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women.
- Conditions
- Pregnancy, Premature Birth, Infant, Low Birth Weight, Pregnancy Outcomes
- Trial name
- NCT00197548
- Testing
- Multivitamins-vitamins B-complex, C, and E
- Volunteers
- 8,468 people
- Sponsor
- Harvard School of Public Health (HSPH)