Clinical trials: Exposure During Pregnancy
MASH - Metabolic Dysfunction-Associated Steatohepatitis
Rezdiffra Pregnancy and Lactation Registry
To evaluate pregnancy and clinical outcomes in women with NASH and their infants after exposure to Rezdiffra at any time during pregnancy and/or lactation.
- Trial name
- NCT07541469
- Testing
- Rezdiffra
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Noise Exposure
Exposure to Intense and Prolonged Noises During Pregnancy
Hearing is an essential element for the development of language and conditions an appropriate cognitive, psychological and social development of children.
- Trial name
- GestaNoise (NCT05911204)
- Testing
- Questionnaire about intense noises exposure during pregnancy
- Where
- France
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Central Hospital, Nancy, France
Generation of Anti COVID-19 Antibodies in a Fetus, Whose Mother Was Exposed to COVID or Was Vaccinated During Pregnancy
COVID 19 ANTOBODIES IN PREGNANT WOMEN AND THEIR CONNECTION TO BETA CELL FUNCTION IN THE FETUS
The aim of this study is to check for the presence of COVID 19 antibodies [Covid-19, GAD-65, IA-2, ICA] in the blood of laboring women who have been exposed to either the virus itself or to the vaccine during pregnancy .
- Trial name
- NCT04860908
- Testing
- no intervention, observation only
- Where
- Israel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Maaynei Hayesha Medical Center
Meningococcal Infection
Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
Primary Objective: To assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi® during pregnancy or in the 30 days preceding their Last Menstrual Period (LMP).
- Trial name
- NCT04843111
- Testing
- Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Sleep Initiation and Maintenance Disorders, Pregnancy
A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population
The primary purpose of the study is to compare the occurrence of major congenital malformations (MCMs) among live births between women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and women with…
- Trial name
- NCT06744673
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 861 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Migraine
Aimovig Pregnancy Exposure Registry
The primary objective of this study is to estimate the proportion of major congenital malformations in infants of women with migraine exposed to erenumab-aooe during pregnancy compared to infants of women with migraine unexposed…
- Trial name
- NCT06150781
- Testing
- erenumab-aooe
- Where
- United States
- Volunteers
- 2,842 people, healthy volunteers welcome
- Sponsor
- Amgen
Crohn's Disease, Rheumatoid Arthritis
OTIS Cimzia Pregnancy Registry
The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live…
- Conditions
- Crohn's Disease, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- Trial name
- NCT01797224
- Where
- United States
- Volunteers
- 925 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Psoriasis (PsO)
A Study to Assess Deucravacitinib Safety in Pregnancy
The purpose of this study is to assess pregnancy and infant outcomes among pregnant participants enrolled in an established North American pregnancy registry (Organization of Teratology Information Specialists [OTIS]) who were…
- Trial name
- NCT07017699
- Testing
- Deucravacitinib, Other systemic treatments for PsO
- Where
- United States
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Colitis, Ulcerative, Crohn's Disease
OTIS Vedolizumab Pregnancy Exposure Registry
The purpose of this study is to assess the prevalence of major structural birth defects in infants of female participants with ulcerative colitis (UC) or Crohn's disease (CD) exposed to vedolizumab during pregnancy, compared to…
- Trial name
- NCT02678052
- Testing
- Vedolizumab, Other Biological Agent
- Where
- United States
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- Takeda
Exposures Associated With Pregnancy, Delivery and Lactation
Impact of Perinatal Exposure to Non-caloric Sweeteners on Food Preferences and Weight Gain in the First Year of Life
During last years, non-caloric sweeteners (NCSs) have been increasingly incorporated into foodstuffs in replacement of sucrose in Chile.
- Trial name
- NCT03972176
- Volunteers
- 315 people, healthy volunteers welcome
- Sponsor
- University of Chile
Rheumatoid Arthritis -Exposure During Pregnancy
An Observational Study on Sarilumab-exposed Pregnancies
Primary Objective: To evaluate the relative risk of major structural birth defects, specifically a pattern of anomalies, in sarilumab-exposed pregnancies compared to disease-matched unexposed pregnancies.
- Trial name
- NCT03378219
- Testing
- Sarilumab SAR153191 (REGN88)
- Where
- 2 sites in United States, Canada
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Sanofi
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
Depression
Antidepressant Use During Pregnancy
This study will determine the safety of antidepressant use during pregnancy for both the mother and the child.
- Trial name
- NCT00279370
- Where
- United States
- Volunteers
- 283 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Environmental Exposure, Pregnancy Related
Prenatal Education on Environmental Exposures During Pregnancy Study (PEEPS)
The purpose of this project is to reduce maternal environmental exposures to toxicants through a patient education program designed to help pregnant women learn about exposure through consumption of contaminated seafood and to be…
- Conditions
- Environmental Exposure, Pregnancy Related, Preterm Birth, Chronic Respiratory Disease
- Trial name
- PEEPS (NCT07758114)
- Testing
- Educational Intervention
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
Vaccine Exposure During Pregnancy
PREHEVBRIO Pregnancy Outcomes Registry
The registry is an observational surveillance program designed to recruit and encourage participation of women who were exposed to PREHEVBRIO® hepatitis B vaccine during pregnancy and to collect and analyze information related to…
- Trial name
- NCT06097312
- Testing
- Data collection
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- VBI Vaccines Inc.
Non-birthing Partner Vaccination in Pregnancy, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Assessing Interventions to Increase Tdap Acceptance for Non-birthing Partners in Pregnancy
The goal of this randomized control trial is to assess if prenatal vaccine education and in-office vaccination administration for non-birthing partners of pregnant patients increases Tdap vaccination rates compared to usual care.
- Conditions
- Non-birthing Partner Vaccination in Pregnancy, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, Vaccine Exposure During Pregnancy
- Trial name
- ITAPP (NCT06135636)
- Testing
- Education, Vaccine administration
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Women and Infants Hospital of Rhode Island
Hypercholesterolemia
Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
Primary Objective: To estimate the overall combined rate of major structural birth defects in infants of mothers with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) exposed to Praluent®…
- Trial name
- NCT03379558
- Testing
- ALIROCUMAB SAR236553 (REGN727)
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Phthalate Exposure, Preeclampsia
The Relationship of Phthalate Exposure During Pregnancy and Preeclampsia
Phthalates are a group of ubiquitous synthetic endocrine-disrupting chemicals. Fetal and neonatal periods are particularly susceptible to endocrine disorders, which prenatal exposure to phthalates causes.
- Conditions
- Phthalate Exposure, Preeclampsia, Estrogen, Progestin
- Trial name
- NCT04777929
- Testing
- test Phthalates, estrogen and progesterone
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
HIV Infections, Exposure During Pregnancy
Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers ( NEUROPSY-HEU )
Main objective: to evaluate the executive functioning of the HIV exposed uninfected children (HEU) versus children from the same socio-economic and cultural environment, not infected or affected by HIV.
- Conditions
- HIV Infections, Exposure During Pregnancy, Neurophysiologic Abnormality, Executive Dysfunction
- Trial name
- NEUROPSY-HEU (NCT04108728)
- Testing
- BRIEF SCORE AT INCLUSION
- Where
- 3 sites in France
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Nantes University Hospital
Early Childhood, Neurodevelopment, Early Childhood, Anthropometry
Environmental Pollutants in Pregnancy - IoMumNEXT
Globally 12.6 million people, including 1.7 million children under the age of 5, die each year from environmental-related illnesses.
- Trial name
- IoMumNEXT (NCT06226311)
- Testing
- Data collection, Diagnostic Test: Urinary
- Where
- Portugal
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Universidade do Porto