Clinical trials: Exposure During Pregnancy
- Condition Exposure During Pregnancy
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Multiple Sclerosis
Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks…
- Trial name
- NCT05658497
- Testing
- Diroximel Fumarate, Avonex, Tysabri
- Where
- 8 sites in United States, Australia and 5 more
- Volunteers
- 908 people
- Sponsor
- Biogen
Inflammatory Bowel Disease
Analysis of Birth Outcomes of Swedish, Danish and Finnish Women Exposed to Remicade With Inflammatory Bowel Disease, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Psoriasis
The purpose of this study is collection and analysis of information pertaining to pregnancy outcomes in women exposed to infliximab during pregnancy, relative to the background risk in similar but non-biologic exposed patients…
- Trial name
- NCT00658827
- Testing
- No intervention
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- Janssen Biotech, Inc.
Maternal Outcomes, Infant Outcomes
Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy
The primary objectives of this study are: In infants of women exposed to SPIKEVAX during pregnancy, to assess: If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of major congenital…
- Conditions
- Maternal Outcomes, Infant Outcomes, Pregnancy
- Trial name
- NCT06369272
- Where
- United States
- Volunteers
- 1,192 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Multiple Sclerosis
The Gilenya Pregnancy Registry
The purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects in the offspring of women exposed to…
- Trial name
- NCT01285479
- Testing
- Fingolimod
- Where
- 61 sites in United States, Argentina and 32 more
- Volunteers
- 312 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis, Pregnancy
Fampridine Pregnancy Exposure Registry
This is a global pregnancy registry to evaluate the outcomes of pregnancy in women with multiple sclerosis who have been exposed to prolonged-release fampridine since the first day of their last menstrual period prior to…
- Trial name
- NCT01532154
- Testing
- Fampridine
- Where
- France
- Volunteers
- 1 people
- Sponsor
- Biogen
Rheumatoid Arthritis
Abatacept Pregnancy Exposure Registry
The purpose of the abatacept pregnancy registry is to monitor planned and unplanned pregnancies exposed to abatacept, to evaluate the possible teratogenic effects (that is, any abnormal development) of this medication in the…
- Trial name
- NCT01087125
- Testing
- No Interventions
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Bristol-Myers Squibb
Migraine
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
The purpose of the study is to evaluate the risk of pregnancy and infant outcomes among women with migraine exposed to rimegepant during pregnancy and in two rimegepant unexposed comparator groups.
- Trial name
- NCT05198245
- Testing
- Rimegepant, Various, No intervention
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Pfizer
Infections, Meningococcal
Safety of 4CMenB Exposure During Pregnancy
4CMenB was approved by the Food and Drug Administration (FDA) in the United States in January 2015 for people aged 10 through 25 years of age.
- Trial name
- NCT02640677
- Testing
- 4CMenB
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- GlaxoSmithKline
Pregnancy, Obesity
A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy
This is an observational cohort study using administrative insurance claims data. The aim of this non-interventional study (NIS) is to compare maternal, fetal and infant outcomes of women exposed to Wegovy during pregnancy to a…
- Conditions
- Pregnancy, Obesity, Overweight
- Trial name
- NCT05503927
- Testing
- No Intervention
- Where
- 2 sites in United States
- Volunteers
- 2,701 people
- Sponsor
- Novo Nordisk A/S
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
Pregnancy Related, Atopic Dermatitis
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis
This study is to assess infant outcomes of women with AD who were exposed to ruxolitinib cream during pregnancy compared with a control cohort of women with AD who were exposed to a topical corticosteroid (TCS) during pregnancy.
- Trial name
- NCT06627335
- Testing
- Ruxolitinib Cream, TCS
- Where
- United States
- Volunteers
- 5,621 people
- Sponsor
- Incyte Corporation
All Indications for Glivec/Gleevec and Tasigna
A Global Imatinib and Nilotinib Pregnancy Exposure Registry
This is a voluntary, international, primarily prospective, observational, exposure-registry and follow-up study of women receiving Imatinib and Nilotinib during pregnancy or within six months prior to pregnancy.
- Trial name
- NCT01289054
- Testing
- Tasigna, Gleevec
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Influenza
FluLaval® Quadrivalent Pregnancy Registry
The purpose of this pregnancy registry study is to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with FluLaval Quadrivalent.
- Trial name
- NCT02000466
- Testing
- Data collection
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Crohn's Disease, Prenatal Exposure
Pregnancy Exposure Registry for Tysabri®
The primary objective of the Registry was to evaluate the outcomes of pregnancy in women with Multiple Sclerosis (MS) or Crohn's Disease (CD) who were exposed to TYSABRI® at any time within 90 days prior to first day of Last…
- Conditions
- Crohn's Disease, Prenatal Exposure, Multiple Sclerosis, Pregnancy
- Trial name
- NCT00472992
- Where
- United States
- Volunteers
- 376 people
- Sponsor
- Biogen
Neuromyelitis Optica Spectrum Disorder, Pregnancy Related
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or…
- Trial name
- NCT05909761
- Testing
- UPLIZNA
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Amgen
Pregnancy Related
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period [LMP]).
- Trial name
- NCT07556913
- Testing
- Elafibranor
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Ipsen
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
Pregnancy Related
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12…
- Trial name
- NCT06258902
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Ipsen
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