Clinical trials: Exposure During Pregnancy
Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy, Pregnancy
TEGSEDI Pregnancy Surveillance Program
This is a worldwide safety surveillance study of pregnancy outcomes in women with hATTR-PN who may have been exposed or were not exposed to TEGSEDI prior to or during the pregnancy and of pediatric outcomes up to 1 year of age.
- Trial name
- NCT04270058
- Testing
- inotersen
- Volunteers
- 20 people
- Sponsor
- Akcea Therapeutics
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
Ulcerative Colitis
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants
The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is…
- Trial name
- NCT06126835
- Testing
- Ozanimod, Conventional therapy, Advanced therapy
- Where
- United States
- Volunteers
- 2,828 people
- Sponsor
- Bristol-Myers Squibb
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
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
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
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
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
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
Pregnancy
Global Lomitapide Pregnancy Exposure Registry
To evaluate the outcomes of pregnancy in women treated with lomitapide.
- Trial name
- NCT02399839
- Testing
- lomitapide
- Where
- Germany
- Volunteers
- 5 people
- Sponsor
- Amryt Pharma
Herpes Zoster
Safety of Herpes Zoster Subunit (HZ/su) Vaccine During Pregnancy in Adult Women With Immunocompromised Conditions
The purpose of this post-marketing commitment safety study is to evaluate the real-world safety of HZ/su vaccine during pregnancy in immunodeficient or immunosuppressed adult pregnant women between 18 and 49 years of age in the…
- Trial name
- NCT05811754
- Testing
- Data collection
- Where
- United States
- Volunteers
- 2,844 people
- Sponsor
- GlaxoSmithKline
Healthy
Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects
This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine on cardiovascular parameters in healthy subjects 50 years of age and older
- Trial name
- NCT00413790
- Testing
- Darifenacin, Tolterodine
- Where
- 12 sites in United States
- Volunteers
- 162 people
- Sponsor
- Novartis
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
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
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
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.
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
Hypercholesterolemia; ASCVD; Pregnancy
Evolocumab Pregnancy Exposure Registry
This is a prospective observational registry study to evaluate fetal, infant and childhood outcomes in women exposed to evolocumab during pregnancy
- Trial name
- NCT02957604
- Testing
- evolocumab
- Volunteers
- 140 people
- Sponsor
- Amgen
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
Rheumatoid Arthritis (RA), Crohn's Disease (CD)
UCB Cimzia Pregnancy Follow-up Study
The purpose of this observational follow-up study is to collect data systematically on pregnancies and offspring of women who become pregnant while participating in a Certolizumab Pegol (CZP) study or whose pregnancies have…
- Conditions
- Rheumatoid Arthritis (RA), Crohn's Disease (CD), Psoriatic Arthritis (PsA), Axial Spondyloarthritis and Ankylosing Spondylitis
- Trial name
- NCT02775656
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- UCB BIOSCIENCES, Inc.