Clinical trials: Adverse Pregnancy Outcomes
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
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
Pregnancy Early, Outcome, Adverse Birth
Generation R Next - Optimaal Opgroeien
The aim of this randomized controlled trial is to improve birth outcomes and long-term outcomes in mother and child by optimizing lifestyle,nutrition and stress experience in the preconception period and early pregnancy in women…
- Conditions
- Pregnancy Early, Outcome, Adverse Birth, Lifestyle Factors, Preconception Care
- Trial name
- NCT05870878
- Testing
- Standard care, Lifestyle program
- Where
- Netherlands
- Volunteers
- 1,750 people, healthy volunteers welcome
- Sponsor
- Erasmus Medical Center
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
SARS-CoV2 Infection, Covid19
SARS-CoV-2 and Acetylsalicylic Acid (SARA)
SARS-CoV-2 infection in pregnancy is associated with an increased risk of adverse maternal and perinatal outcomes. One explanation is that the infection might increase the existing pregnancy-associated prothrombotic status…
- Trial name
- SARA (NCT05073718)
- Testing
- Low-dose acetylsalicylic acid
- Where
- 4 sites in Mozambique, Spain
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Barcelona Institute for Global Health
Maternal Depression
Reducing Risk After an Adverse Pregnancy Outcome
This application to the Boston University Medical Center Institutional Review Board outlines a research plan devoted to identifying and managing maternal depression in Early Intervention (EI).
- Trial name
- NCT01182363
- Testing
- Project Solve Education
- Where
- 4 sites in United States
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- Boston Medical Center
Pregnancy Related, Benzodiazepines Causing Adverse Effects in Therapeutic Use
Maternal and Neonatal Outcomes Following Exposure to Benzodiazepines During Pregnancy
This is a nationwide cohort study to assess maternal and neonatal outcomes following exposure to benzodiazepines during pregnancy.
- Conditions
- Pregnancy Related, Benzodiazepines Causing Adverse Effects in Therapeutic Use, Congenital Anomaly
- Trial name
- NCT04856436
- Testing
- Benzodiazepine
- Where
- South Korea
- Volunteers
- 3,094,227 people, healthy volunteers welcome
- Sponsor
- Sungkyunkwan University
Autoimmune Diseases, Adverse Pregnancy Outcomes
A Post-marketing Observational Database Study Monitoring the Safety of CecolinⓇ
This study was a retrospective-prospective real-world study to assess the safety among females receiving the 2vHPV vaccine (CecolinⓇ).
- Trial name
- HPV-PRO-013 (NCT06824896)
- Where
- China
- Volunteers
- 1,322,084 people, healthy volunteers welcome
- Sponsor
- Xiamen Innovax Biotech Co., Ltd
Zika Virus, Pregnancy Related
ZIKAlliance Pregnant Women Cohort
The aim of this proposal is to evaluate the causal relationship between Zika virus (ZIKV) infections in pregnancy and congenital malformations.
- Trial name
- ZIKAlliancePW (NCT03188731)
- Where
- 14 sites in Bolivia, Brazil and 5 more
- Volunteers
- 3,852 people, healthy volunteers welcome
- Sponsor
- University of Heidelberg Medical Center
Obstructive Sleep Apnea
Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy
Prospective, randomized controlled trial. Pregnant women in early pregnancy will be randomized to either the Sleep Study + CPAP (Continuous Positive Airway Pressure Therapy) group or to a Standard Prenatal Care group.
- Trial name
- NCT02755831
- Testing
- CPAP, Pre-natal care
- Where
- United States
- Volunteers
- 193 people, healthy volunteers welcome
- Sponsor
- United States Naval Medical Center, San Diego
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
Small for Gestational Age at Delivery, Hypoxic-Ischemic Encephalopathy
Umbilical Cord Abnormalities in the Prediction of Adverse Pregnancy Outcomes
The objective of our study is to investigate the association of umbilical cord abnormalities with adverse pregnancy outcomes. The umbilical cord parameters that will be investigated as part of this study include the umbilical…
- Conditions
- Small for Gestational Age at Delivery, Hypoxic-Ischemic Encephalopathy, Stillbirth, Admission to Neonatal Unit
- Trial name
- ULOOP (NCT05901688)
- Testing
- Umbilical cord measurements & observations
- Where
- United Kingdom
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Medway NHS Foundation Trust
Experiential Classroom, Health Behavior
The Effect of Experiential Classroom on Establishing Healthy Behaviors During Pregnancy
A multi-center, prospective, randomized controlled clinical trial was conducted to explore the effect of experiential classroom on establishing healthy behaviors during pregnancy.
- Conditions
- Experiential Classroom, Health Behavior, Preconception Education, Adverse Pregnancy Outcome
- Trial name
- NCT06413303
- Testing
- Experiential Classroom
- Where
- China
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Peking Union Medical College Hospital
Pregnancy Related, Influenza Virus Vaccine Adverse Reaction
Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy
This is a nationwide cohort study to assess maternal and fetal outcomes following vaccination with a quadrivalent influenza vaccine (QIV) during pregnancy.
- Trial name
- NCT04579822
- Testing
- influenza vaccine
- Volunteers
- 300,000 people, healthy volunteers welcome
- Sponsor
- Sungkyunkwan University
Adiposity
Maternal Lipids and Offspring Adiposity at 5-7 Years
This study investigates the associations between measured maternal lipids (Total cholesterol, LDL-cholesterol , triglycerides and high-density lipoprotein cholesterol) at 28 weeks' gestation and offspring adiposity at 5-7 years.
- Trial name
- HAPO (NCT03317522)
- Volunteers
- 1,224 people, healthy volunteers welcome
- Sponsor
- Belfast Health and Social Care Trust
Adenomyosis, Pregnancy Complications
The Effect of Adenomoyosis on Pregnancy Outcomes
Adenomyosis can be defined as the settling of endometrial gland cells in the myometrium and deformity in the uterus and the prevalence of adenomyosis is according to the patient population and countries around 20%.
- Trial name
- NCT04894292
- Testing
- Non intervention
- Where
- Turkey (Türkiye)
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Tepecik Training and Research Hospital
Pregnancy Complications
Prenatal Sonographic Prediction of Placental Histology and Function
The purpose of this two-phase observational study is to investigate the use of ultrasonography to predict placental pathology at the time of delivery.
- Trial name
- NCT06022458
- Where
- United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
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
Neurodegenerative Diseases, Osteoarthritis
Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions
To evaluate for any adverse effects that may be related to the administration and reception of autologous adipose derived stromal vascular fraction (SVF).
- Conditions
- Neurodegenerative Diseases, Osteoarthritis, Erectile Dysfunction, Autoimmune Diseases
- Trial name
- NCT01953523
- Testing
- Administration of autologous adipose derived SVF
- Where
- United States
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Elliot Lander
Environmental Exposure, Pregnancy Outcome
The Ma'Anshan Birth Cohort (MABC)
The Ma'anshan Birth Cohort (MABC) is a population-based prospective pregnancy and birth cohort study that aims to explore the early environmental and genetic determinants of maternal and child health, with a focus on health…
- Conditions
- Environmental Exposure, Pregnancy Outcome, Birth Defects, Child Development
- Trial name
- NCT03215368
- Where
- China
- Volunteers
- 3,474 people, healthy volunteers welcome
- Sponsor
- Anhui Medical University