Clinical trials: Maternal Exposure
Phenylketonuria, Maternal
A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding
This is a Phase 4 observational study designed to assess the impact of Palynziq ® (pegvaliase) treatment in pregnant women with PKU and on their offspring who were exposed to pegvaliase at any time during pregnancy and…
- Trial name
- PALomino (NCT05579548)
- Testing
- Pegvaliase
- Where
- 4 sites in United States, Canada and 2 more
- Volunteers
- 50 people
- Sponsor
- BioMarin Pharmaceutical
Postpartum Depression
Study of Exposure to Stress, Postpartum Mood, Adverse Life Events, and Hormonal Function Among Latinas (SEPAH Latina)
The purpose of the funded study is to determine a) examine associations among OT levels, stress, trauma history, PPD, and lactation failure in the full 60-subject sample and assess whether there are differences between immigrant…
- Trial name
- SEPAH (NCT01912833)
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Maternal Distress, Child Development
In Vitro Fertilization (IVF) and Prenatal Effects Independent of Genetics
This study examines how maternal stress during pregnancy affects infant brain and behavioral development, focusing on whether these effects are due to the prenatal environment or shared genes.
- Trial name
- NCT07296107
- Testing
- Prenatal maternal psychosocial and biological assessment protocol
- Where
- United States
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Columbia University
Pregnancy Related
EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure)
The Prevention Agent Pregnancy Exposure Registry, also known as EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) is a prospective observational cohort investigation of exposures to study…
- Trial name
- EMBRACE (NCT01209754)
- Where
- 17 sites in United States, South Africa and 2 more
- Volunteers
- 873 people, healthy volunteers welcome
- Sponsor
- Microbicide Trials Network
Maternal Exposure During Pregnancy
Effect of Dietary Counseling During Pregnancy on Infant Birthweight in Mangochi , Malawi
High neonatal mortality rates accounts for a substantial early loss of lives in Malawi; and has thus been a hindrance for Malawi to eradicate child deaths.
- Trial name
- NCT03136393
- Testing
- Community based dietary counselling, Community based antenatal counselling
- Where
- Malawi
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of Oslo
Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development
A Study to Learn More About the Relationship Between the Development of a Gap in the Upper Lip (Cleft Lip) or in the Roof of the Mouth (Cleft Palate) in Newborns and the Use of Glucocorticoids by the Mother During Pregnancy: a Meta-analysis
Glucocorticoids are drugs that have many effects on body metabolism, raise sugar level in the blood, and reduce inflammation. By applying a statistical technique for combining the findings from a systematic literature review…
- Trial name
- NCT03788863
- Testing
- Diflucortolone valerate (BAY866146)
- Where
- Germany
- Volunteers
- 99,999 people, healthy volunteers welcome
- Sponsor
- LEO Pharma
Adverse Pregnancy Outcomes
The Mechanism of Adverse Pregnancy Outcomes Influenced by Maternal Air Pollution Exposure
This research evaluates the effects of maternal exposure to air pollution during pregnancy on adverse pregnancy outcomes, the general demographic information, the level of maternal exposure to air pollution, pregnancy-related…
- Trial name
- NCT04215406
- Testing
- The level of air pollution
- Where
- China
- Volunteers
- 288 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Lead Poisoning
Lead Mobilization & Bone Turnover in Pregnancy/Lactation
We are examining the role of maternal bone lead turnover during pregnancy and lactation as a potential source of lead exposure for the fetus and the infant (via breast milk).
- Trial name
- NCT00011726
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- National Institute of Environmental Health Sciences (NIEHS)
Sexually Transmitted Diseases
Prospective Registry of Exposure to Gepotidacin (PREG)
The purpose of this study is to monitor pregnancies exposed to gepotidacin and to evaluate possible teratogenic effects or birthweight-lowering effects of this medication relative to the primary outcomes of major congenital…
- Trial name
- NCT07850141
- Testing
- None (Observational study)
- Volunteers
- 614 people
- Sponsor
- GlaxoSmithKline
Pregnancy Related, Immune-mediated Diseases
Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System Development
What is this project about? This project aims to better understand how the immune system develops in babies whose mothers received immunomodulatory treatments during pregnancy.
- Trial name
- NEWbornIMMPACT (NCT07033663)
- Testing
- Monoclonal antibody
- Where
- 3 sites in Spain
- Volunteers
- 90 people
- Sponsor
- Fundació Sant Joan de Déu
Metabolic Diseases, Neurological and Mental Health Conditions
Growing Up in Singapore Towards Healthy Outcomes
This study aims to examine the role of genetic and epigenetic factors, maternal nutrition, lifestyle, emotional health, and other environmental factors in pregnancy or postpartum period that can influence future maternal risk of…
- Conditions
- Metabolic Diseases, Neurological and Mental Health Conditions, Genetic Predisposition, Skin Condition
- Trial name
- GUSTO (NCT01174875)
- Where
- Singapore
- Volunteers
- 1,247 people, healthy volunteers welcome
- Sponsor
- National University Hospital, Singapore
Substance-Related Disorders, Pregnancy, High Risk
A Prenatal Mentalization-focused 4D Ultrasound and a Pregnancy Diary Intervention for Substance-abusing Women
Objective: This randomized and controlled trial was aimed at exploring the effect of a new mentalization-focused 4D interactive ultrasound and a week-by-week pregnancy diary intervention with substance-abusing pregnant women.
- Conditions
- Substance-Related Disorders, Pregnancy, High Risk, Prenatal Care, Maternal-Fetal Relations
- Trial name
- NCT03413631
- Testing
- Prenatal mentalization intervention, Prenatal obstetric treatment as usual
- Where
- Finland
- Volunteers
- 126 people
- Sponsor
- Turku University Hospital
Postpartum Hemorrhage
In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age and Morbid Obesity
Women with advanced maternal age and morbid obesity, have a higher incidence of labor induction/ augmentation and cesarean section (CS), and are at a greater risk for postpartum hemorrhage (PPH).
- Trial name
- NCT01865669
- Testing
- Oxytocin
- Where
- Canada
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Hiv
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women
To reach HIV-uninfected pregnant and breastfeeding women in South Africa, who are at very high risk of HIV, researchers will test a new and innovative package of interventions: 1) pre-exposure prophylaxis (PrEP), which is a daily…
- Trial name
- SCOPE-PP (NCT05322629)
- Testing
- PrEP adherence biofeedback, Standard of care counseling
- Where
- South Africa
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Hiv
Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)
The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the…
- Trial name
- PrEP-PP (NCT03826199)
- Testing
- TDF-FTC, Counselling on PrEP in antenatal and postnatal care
- Where
- South Africa
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Fetal Alcohol Syndrome, Substance Abuse
Fetal Alcohol Damage Prevention Study
The goal of this study was to determine whether a series of blood markers of alcohol use obtained from alcohol using pregnant women could help them to change their behavior.
- Trial name
- NCT00696085
- Testing
- Brief motivational intervention
- Where
- United States
- Volunteers
- 612 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Pregnancy, Pregestational Diabetes
Safety of Metformin in Pregnancy
This study aims to better characterize the risk linked to metformin use during pregnancy, using a prospective multicentric cohort design enabling a large sample size, in evaluating the rate of birth defects after first trimester…
- Conditions
- Pregnancy, Pregestational Diabetes, Polycystic Ovary Syndrom
- Trial name
- NCT02793505
- Testing
- metformin, any drug not known as a major teratogen or major fetotoxicant
- Volunteers
- 950 people
- Sponsor
- Centre Hospitalier Universitaire Vaudois
Congenital Heart Disease
Study on the Relationship Between Maternal Exposure to Environmental Factors and Fetal Congenital Heart Disease
The objective of this study is to research the relationship between maternal exposure to environmental factors and fetal congenital heart disease in a community-based case-control study.
- Trial name
- NCT02914392
- Where
- 2 sites in China
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Diphtheria
A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.
The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in a maternal immunization program in Brazil.
- Trial name
- NCT02757950
- Testing
- Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]
- Where
- Brazil
- Volunteers
- 2,462 people
- Sponsor
- GlaxoSmithKline
Enteral Feeding
Studying the Influence of Exposure to Maternal Voice on Oral Feeding Volumes in Preterm Infants
Oral feeding is one of the primary functions of the neonatal brain. In preterm infant population, competency at oral feeding is one of the major milestones in preparation for discharge.
- Trial name
- NCT05181020
- Testing
- Maternal Voice Exposure
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Connecticut Children's Medical Center