Clinical trials: Exposure During Pregnancy
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
Psoriatic Arthritis, Psoriasis
Apremilast Pregnancy Exposure Registry
The purpose of the Apremilast Pregnancy Exposure Registry is to monitor planned and unplanned pregnancies exposed to apremilast and to evaluate the safety of this medication relative to specified pregnancy outcomes, and to…
- Trial name
- NCT02775500
- Testing
- apremilast
- Where
- United States
- Volunteers
- 233 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
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.
Meningococcal Disease
A Study to Learn About the Safety of PENBRAYA During Pregnancy
This study is a pregnancy registry designed to learn more about the safety of the study vaccine PENBRAYA (a vaccine that protects against meningitis causing bacteria) when it is given during pregnancy or within 30 days before the…
- Trial name
- NCT07768163
- Testing
- PENBRAYA
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Pfizer
Perinatal Mental Health, Gestational Weight Gain
Healthy Adaptation to Pregnancy, Postpartum and Parenthood
Healthy Adaptation to Pregnancy, Postpartum and Parenthood (HAP3) The HAP3 study is evaluating a new digital support program for pregnant women and their partners.
- Conditions
- Perinatal Mental Health, Gestational Weight Gain, Postpartum Weight Retention, Child Development
- Trial name
- HAP3 (NCT07837193)
- Testing
- HAP3 Family App
- Where
- Belgium
- Volunteers
- 572 people, healthy volunteers welcome
- Sponsor
- KU Leuven
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
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
Childhood Obesity Prevention
Anthropometric Outcomes of a Mobile Health Intervention for Eating Behaviour and Lifestyle in Infancy
Lifestyle, activity, and feeding behaviours during early childhood set the foundation for subsequent lifelong metabolic health as an adult.
- Trial name
- NCT06457750
- Testing
- Feeding, Lifestyle, Activity Goals (FLAGs) Digital Health Application
- Where
- Singapore
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- KK Women's and Children's Hospital
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
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
Postpartum Hemorrhage
In Vitro Evaluation of Spontaneous and Oxytocin-induced Contractility of Pregnant Human Myometrium During Exposure to Dexmedetomidine
Postpartum hemorrhage (PPH) remains to be one of the leading causes of maternal morbidity and mortality. It has been noted that an increasing number of PPH is attributed to the increased incidence of uterine atony.
- Trial name
- NCT05511415
- Testing
- Oxytocin, Dexmedetomidine
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
General Anaesthesia During Pregnancy
Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia
Every year in the European Union, thousands of babies are exposed to anaesthesia before they are born because their mothers need surgery during pregnancy.
- Trial name
- PAE-IQ (NCT06633406)
- Testing
- Age-appropriate Wechsler Intelligence Test, Disruptive Behavior Disorders Rating Scale, Social Responsiveness Scale
- Where
- 3 sites in Belgium
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
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
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
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
HIV Infections, Pregnancy Related
mWACh-PrEP: A SMS-based Support Intervention to Enhance PrEP Adherence During Pregnancy and Breastfeeding
In high HIV prevalence regions, women are at high risk for HIV during pregnancy and breastfeeding. To protect women and reach elimination of mother-to-child HIV transmission, the World Health Organization recommends offering oral…
- Conditions
- HIV Infections, Pregnancy Related, Adherence, Medication
- Trial name
- NCT04472884
- Testing
- mWACh-PrEP, Standard of Care
- Where
- 4 sites in Kenya
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- University of Washington
Multiple Sclerosis
LEMTRADA Pregnancy Registry in Multiple Sclerosis
Primary Objective: The primary goal of this registry is to assess the risk of spontaneous abortion in prospective enrolled women exposed to LEMTRADA for multiple sclerosis.
- Trial name
- NCT03774914
- Testing
- Alemtuzumab (GZ402673)
- Where
- 12 sites in United States, Australia and 10 more
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Child Development, Cannabis Use
Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development
The goal of this study is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women who have used cannabis products during the current pregnancy improves the offspring\'s brain-related…
- Trial name
- NCT06379971
- Testing
- Choline
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
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
Pregnancy Related
Pregistry International Pregnancy Exposure Registry (PIPER)
The aims of the Pregistry International Pregnancy Exposure Registry (PIPER) are to provide early signals of risk after prenatal exposure to medical products and to define boundaries of safety for medical products.
- Trial name
- PIPER (NCT05352256)
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Pregistry