Clinical trials: Maternal Exposure
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
Friedreich Ataxia
A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies
In this study, researchers will learn more about the safety of BIIB141, also known as omaveloxolone or SKYCLARYS. This is a drug available for doctors to prescribe for people with Friedrich's Ataxia, also known as FA.
- Trial name
- NCT06628687
- Testing
- Omaveloxolone
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Biogen
Diabetes Mellitus, Type 2, Pregnancy in Diabetic
The Effect of In-utero Exposure to Metformin in 5-11 Year Old Offspring of Mothers in the MiTy Trial
The incidence of diabetes in pregnancy is rising, with rates of 1 in 7 pregnancies globally. Metformin is used for type 2 diabetes (T2DM) outside of pregnancy and is now increasingly prescribed during pregnancy.
- Conditions
- Diabetes Mellitus, Type 2, Pregnancy in Diabetic, Child Obesity, Child Development
- Trial name
- MiTy Tykes (NCT05025852)
- Where
- 12 sites in Australia, Canada
- Volunteers
- 132 people
- Sponsor
- Mount Sinai Hospital, Canada
Atopic Dermatitis
Prenatal Exposure to Emerging Contaminants and Children's Atopic Dermatitis
This prospective cohort study aims to investigate the association between prenatal blood levels of Emerging Contaminants and the five-year incidence of atopic dermatitis (AD) in offspring.
- Trial name
- PECCAD (NCT06316609)
- Testing
- Gestational Exposure to Emerging Contaminants (ECs)
- Where
- China
- Volunteers
- 456 people
- Sponsor
- Children's Hospital of Fudan University
Domestic Violence, Child Abuse
Cluster RCT of Embedded Parenting Intervention to Prevent Recurrence and Reduce Impairment in Young Children Exposed to Domestic Violence
The current cluster randomized trial examines the efficacy of embedding two different parenting interventions within child protection services for young children (0 to 4) who have been exposed to domestic violence and who are at…
- Trial name
- SafeUnderstood (NCT03198429)
- Testing
- Caring Dads, Mothers in Mind
- Where
- 2 sites in Canada
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Toronto
Pregnancy Related, Atopic Dermatitis
Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population
This observational (enrollment into the registry while the pregnancy is ongoing) study is being conducted to compare the frequency of major congenital malformation (MCM)s among infants of women exposed to ruxolitinib cream during…
- Trial name
- OPERA-1 (NCT06259669)
- Testing
- Ruxolitinib Cream
- Where
- United States
- Volunteers
- 958 people
- Sponsor
- Incyte Corporation
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
Offspring Exposed to GDM and Control
PREG - Offspring: Investigation of Children From Mothers With and Without Gestational Diabetes
Gestational diabetes is the most common complication during pregrancy. With a screening between week 24 and 28 of gestation women with gestational diabetes can be identified and treated.
- Trial name
- NCT04722900
- Testing
- intrauterine exposure to elevated glucose levels
- Where
- Germany
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University Hospital Tuebingen
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
HIV Infections, Immune Activation
The University of Zimbabwe College of Health Science (UZ-CHS) BIRTH COHORT Study
Background Commencement of lifelong highly active antiretroviral therapy (HAART) immediately after HIV diagnosis (option B+), for treatment of human immunodeficiency virus (HIV), has greatly improved maternal-infant health in sub…
- Conditions
- HIV Infections, Immune Activation, Comorbidities
- Trial name
- UZ-CHS-BC (NCT04087239)
- Testing
- HIV
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- University of Zimbabwe
Neonatal Abstinence Syndrome
Utility of Psychosocial Intervention in Improving Outcome for Methadone-exposed Infants and Their Mothers
Opiate drug abuse/addiction is a significant co-morbidity in pregnancy. Opiate maintenance program enhances the outcome of pregnancies for the mother and the infant.
- Trial name
- HOPE (NCT01889121)
- Testing
- Structured psychosocial intervention
- Where
- United States
- Volunteers
- 113 people
- Sponsor
- Dr. Henry Akinbi
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
Respiratory Syncytial Virus (RSV), Maternal Vaccine Exposure
Respiratory Syncytial Virus (RSV) and Vaccination in Pregnancy
Respiratory Syncytial Virus (RSV) is the leading cause of chest infections (pneumonia and bronchiolitis) in young children, and is a major cause of admission to hospital and childhood death worldwide.
- Conditions
- Respiratory Syncytial Virus (RSV), Maternal Vaccine Exposure, Attitude
- Trial name
- NCT03096574
- Testing
- Questionnaire
- Where
- 4 sites in United Kingdom
- Volunteers
- 1,025 people, healthy volunteers welcome
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Thrombocytopenia, Small for Gestational Age (SGA)
Mechanism of Thrombocytopenia in Infants
This research project is studying the causes for low platelet levels in preterm infants. Platelets are a component of blood that helps with clotting.
- Conditions
- Thrombocytopenia, Small for Gestational Age (SGA), Preeclampsia
- Trial name
- NCT00333333
- Testing
- Cord blood
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services
Lung Diseases
Assessment of Exposures of the Mother-infant Pair to the Air Pollution of São Paulo
A single group of pregnant women who was analyzed in the first and in the third trimesters of pregnancy
- Trial name
- NCT02807038
- Testing
- Lung function test
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Violence, Domestic
Healing Circles: An Intervention for Canadian Indigenous Mothers & Children Affected by IPV
Evaluation of Mother's Empowerment Program and Kid's Club Program adapted specifically for Indigenous mothers and children affected by intimate partner violence in Canada
- Trial name
- NCT04235335
- Testing
- Indigenous Mother's Empowerment Program & Indigenous Kid's Club Program
- Where
- Canada
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- University of Manitoba
Hypoparathyroidism
A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
The purpose of this registry study is to collect both prospective and retrospective data in women exposed to palopegteriparatide during pregnancy to assess risk of pregnancy and maternal complications, and adverse effects on the…
- Trial name
- NCT07345494
- Testing
- Palopegteriparatide
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Ascendis Pharma A/S
Pre-exposure Prophylaxis, HIV Prevention
UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
The primary purpose of this study is to assess the safety of long-acting injectable cabotegravir (CAB-LA) and oral pre-expose prophylaxis (PrEP) (FTC/TDF or 3TC/TDF) for the prevention of HIV during pregnancy and breastfeeding…
- Conditions
- Pre-exposure Prophylaxis, HIV Prevention, Pregnancy Related
- Trial name
- PrIMO (NCT06158126)
- Testing
- Initiating daily oral PrEP during pregnancy, Already using daily oral PrEP at the time of pregnancy diagnosis, Initiating injectable PrEP during pregnancy
- Where
- Malawi
- Volunteers
- 621 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Mother to Child HIV Transmission
HIV Diagnosis and Treatment at Birth for Newborn With High Risk HIV Exposure
Principal objective Assess the operational efficacy of a strategy combining early diagnosis and preventive antiretroviral treatment systematically reinforced from the birth* among infants at high risk of infection with HIV** .
- Trial name
- DIAVINA (NCT03642704)
- Testing
- Reinforced preventive ARV therapy
- Where
- Guinea
- Volunteers
- 56 people
- Sponsor
- ANRS, Emerging Infectious Diseases
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