Clinical trials: Maternal Exposure During Pregnancy, active
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
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
Myasthenia Gravis, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy.
- Trial name
- NCT06299748
- Testing
- Efgartigimod
- Where
- 4 sites in United States, Germany and 2 more
- Volunteers
- 279 people
- Sponsor
- argenx
Insomnia Disorder
Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy
- Trial name
- NCT06393504
- Testing
- Daridorexant, Non-orexin receptor antagonist insomnia medication, No insomnia medication
- Where
- United States
- Volunteers
- 2,095 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
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
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
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
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
Constipation, Pregnancy
A Study to Assess Maternal and Fetal Outcomes After Taking Prucalopride During Pregnancy
This study will collect information on pregnant women diagnosed with constipation from the two large health care insurance claims records. It will include the following groups: Those who took prucalopride.
- Trial name
- NCT04961840
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Takeda
Environmental Exposure, Pregnancy Outcome
The Ma'Anshan Birth Cohort (MABC)
The Ma'anshan Birth Cohort (MABC) is a population-based prospective pregnancy and birth cohort study that aims to explore the early environmental and genetic determinants of maternal and child health, with a focus on health…
- Conditions
- Environmental Exposure, Pregnancy Outcome, Birth Defects, Child Development
- Trial name
- NCT03215368
- Where
- China
- Volunteers
- 3,474 people, healthy volunteers welcome
- Sponsor
- Anhui Medical University
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, Hyperlipidemias
Bempedoic Acid Pregnancy Surveillance Program
Bempedoic acid pregnancy surveillance program
- Trial name
- NCT05103254
- Testing
- Bempedoic Acid, Bempedoic Acid / Ezetimibe
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Esperion Therapeutics, Inc.
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
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
Chagas Disease
An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health
This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied.
- Trial name
- NCT05477953
- Testing
- Nifurtimox (BAYA2502)
- Where
- 12 sites in United States, Argentina and 10 more
- Volunteers
- 50 people
- Sponsor
- Bayer
Maternal Complications, Pregnancy Complication
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their infant up to 12 months of life.
- Conditions
- Maternal Complications, Pregnancy Complication, Birth Outcomes, Adverse, Pregnancy
- Trial name
- NCT06113237
- Testing
- Epidiolex
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 50 people
- Sponsor
- Jazz Pharmaceuticals
Tobacco Smoke Pollution, Maternal Exposure During Pregnancy
Prenatal Tobacco Exposure and Newborn Outcomes: A Maternal Urinary Cotinine Study
Prenatal exposure to tobacco smoke, through either active maternal smoking or secondhand exposure, has been associated with impaired fetal oxygenation, metabolic stress, and adverse early neonatal outcomes.
- Conditions
- Tobacco Smoke Pollution, Maternal Exposure During Pregnancy, Infant, Newborn, Carbon Monoxide Poisoning
- Trial name
- NCT07201181
- Testing
- Maternal Urinary Cotinine Assessment
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Haseki Training and Research Hospital
Fabry Disease, Pregnancy
Maternal and Postnatal Outcomes Study (MOS): A Global Observational Registry Assessing the Safety of Elfabrio® in Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding
The goal of this observational registry is to evaluate the safety and outcomes of pregnancy and lactation in women with Fabry disease who are exposed to pegunigalsidase alfa within 30 days prior to conception and/or during…
- Conditions
- Fabry Disease, Pregnancy, Pregnancy Complications
- Trial name
- MOS (NCT06941025)
- Testing
- Not applicable- observational study
- Where
- 5 sites in United States, Germany and 3 more
- Volunteers
- 10 people
- Sponsor
- Chiesi Farmaceutici S.p.A.