Clinical trials: Exposure During Pregnancy
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
Asthma
Benralizumab Pregnancy Exposure Study
This is a prospective, observational, exposure cohort study of pregnancy and infant outcomes in women with asthma exposed to benralizumab anytime during pregnancy, or within 8 weeks prior to the first day of the last menstrual…
- Trial name
- NCT03794999
- Testing
- Benralizumab-exposure, Exposure to other asthma medications
- Where
- United States
- Volunteers
- 299 people
- Sponsor
- AstraZeneca
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
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
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
- NCT00703703
- Testing
- Darifenacin, Tolterodine
- Where
- 21 sites in United States
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- Novartis
Pregnancy
AMEVIVE® Pregnancy Registry
This is an observational, exposure-registration and follow-up study, to be conducted in the United States (US). The AMEVIVE® Pregnancy Exposure Registry is designed to monitor pregnant subjects and fetuses exposed to AMEVIVE® in…
- Trial name
- NCT00342862
- Testing
- Amevive exposure
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Astellas Pharma Inc
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
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
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
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.
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.
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.
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
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
Muscular Atrophy, Spinal
A Study to Learn How Nusinersen (Spinraza) Affects Participants With Spinal Muscular Atrophy (SMA) Who Took it Before or During Pregnancy And About The Health of Their Babies
In this study, researchers will know more about the effects of nusinersen, also known as Spinraza®, in pregnant participants with spinal muscular atrophy, also known as SMA.
- Trial name
- NCT05789758
- Testing
- No Intervention
- Where
- 14 sites in United States, United Kingdom
- Volunteers
- 20 people
- Sponsor
- Biogen
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
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
Dengue Virus Infection
Observational Study to Evaluate the Safety of CYD Tetravalent Dengue Vaccine (CYD-TDV) in Pregnant Women and Their Offsprings Inadvertently Exposed During Pregnancy
Primary Objective: To evaluate the safety of CYD-TDV in pregnant women and their offsprings inadvertently exposed during pregnancy or up to 30 days preceding their last menstrual period (LMP) with regards to maternal, pregnancy…
- Trial name
- NCT04023708
- Testing
- CYD-TDV Dengue Vaccine
- Where
- Brazil
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Exposure During Pregnancy
Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia
The purpose of this registry is to acquire safety data (including assessment of anti-rHuPH20 antibodies), regarding the course and outcome of pregnancy in women ever treated with HYQVIA.
- Trial name
- NCT02556775
- Testing
- A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment, HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]
- Where
- 8 sites in United States, Czechia and 3 more
- Volunteers
- 16 people
- Sponsor
- Baxalta now part of Shire
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