Clinical trials: Prenatal Exposure
Chronic Idiopathic Constipation (CIC)
Post-Marketing Study of Prucalopride Safety In Pregnancy
This study collects information on pregnant women with ongoing constipation who took prucalopride and those who did not take prucalopride.
- Trial name
- NCT04869280
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Takeda
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.
Erosive Esophagitis, Heartburn
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
The main objective of the study is to compare the maternal, fetal, and infant outcomes of pregnant women who are exposed to vonoprazan during pregnancy with outcomes of an internal comparison cohort of pregnant women who are…
- Conditions
- Erosive Esophagitis, Heartburn, Symptomatic Non-erosive Gastroesophageal Reflux Disease, Helicobacter Pylori Infection
- Trial name
- NCT06660342
- Testing
- Vonoprazan
- Where
- United States
- Volunteers
- 728 people
- Sponsor
- Phathom Pharmaceuticals, Inc.
Prenatal Exposure Delayed Effects, Multiple Sclerosis
Pregnancy Exposure Registry for Avonex (Interferon Beta-1a)
The primary objectives of the study were to prospectively record and analyze birth defects and spontaneous fetal losses in women with multiple sclerosis (MS) exposed to Avonex within approximately 1 week of conception or during…
- Conditions
- Prenatal Exposure Delayed Effects, Multiple Sclerosis, Pregnancy
- Trial name
- NCT00168714
- Testing
- BG9418 (interferon beta-1a)
- Where
- United States
- Volunteers
- 329 people
- Sponsor
- Biogen
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
Migraine
Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.
- Trial name
- MONITOR (NCT05046613)
- Testing
- Rimegepant, Not taking Rimegepant
- Where
- United States
- Volunteers
- 780 people
- Sponsor
- Pfizer
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
Hepatitis
Twinrix Pregnancy Registry
The purpose of the Twinrix Pregnancy Registry is to prospectively collect data describing exposure to Twinrix before or during pregnancy, potential confounding factors (such as exposure to other medications) and information…
- Trial name
- NCT03619590
- Testing
- Data Collection
- Volunteers
- 245 people
- Sponsor
- GlaxoSmithKline
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
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
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
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