Clinical trials: Pregnant Women and Their Offspring
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
Narcolepsy, Obstructive Sleep Apnea
SUNOSI® (Solriamfetol) Pregnancy Registry
The SUNOSI (solriamfetol) Pregnancy Registry is a US- and Canada-based prospective, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep…
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring
- Trial name
- NCT06413420
- Testing
- Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants, No treatment
- Where
- 2 sites in United States
- Volunteers
- 1,731 people
- Sponsor
- Axsome Therapeutics, Inc.
Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment
Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications
The objective of this registry is to compare outcomes of risankizumab-exposed pregnancies with those of pregnancies that were not exposed to risankizumab among women with plaque psoriasis, psoriatic arthritis (PsA), Crohn's…
- Trial name
- NCT04846959
- Testing
- Risankizumab, Comparator
- Where
- 2 sites in United States
- Volunteers
- 818 people
- Sponsor
- AbbVie
Psoriasis
A Study on the Safety of Deucravacitinib Exposure in Pregnant Women and Their Offspring
This observational study aims to assess pregnancy and infant outcomes among pregnant women with psoriasis who have been exposed to deucravacitinib treatment in the USA.
- Trial name
- NCT06710470
- Testing
- Deucravacitinib, Systemic psoriasis medications, No systemic medications
- Where
- United States
- Volunteers
- 833 people
- Sponsor
- Bristol-Myers Squibb
Influenza
Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring
Primary Objective: To evaluate the safety of Flublok Quadrivalent influenza vaccine in pregnant women included in the VAP00003 Study (NCT03694392) and their offspring exposed during pregnancy or up to 28 days preceding the…
- Trial name
- VAP00007 (NCT04460781)
- Testing
- Flublok Quadrivalent influenza vaccine RIV4, Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4
- Where
- United States
- Volunteers
- 96,175 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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.
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
Pompe Disease, Pregnancy
Avalglucosidase Alfa Pregnancy Study
This is a worldwide, descriptive safety study collecting data on women and their offspring exposed to avalglucosidase alfa during pregnancy and/or lactation, to assess the risks of avalglucsodiase alfa on pregnancy and maternal…
- Trial name
- NCT05734521
- Testing
- avalglucosidase alfa-NGPT (GZ402666) IV, avalglucosidase alfa-NGPT (GZ402666)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Sanofi
Pregnant Women, Influenza
Flucelvax Pregnancy Registry
The goal of the registry is to develop a better understanding of the safety of Flucelvax in women and their offspring who were exposed to the vaccine during pregnancy
- Trial name
- NCT02258178
- Testing
- Flucelvax (cTIV)
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Seqirus
Multiple Sclerosis
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis 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 multiple sclerosis (MS) who were exposed to ozanimod during pregnancy; the second is…
- Trial name
- NCT06133049
- Testing
- Ozanimod, Select DMTs other than ozanimod, No DMTs
- Where
- United States
- Volunteers
- 2,961 people
- Sponsor
- Bristol-Myers Squibb
Streptococcal Infection, Gram-positive Bacterial Infection
Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings
The study investigated the immune response induced by the Group B streptococcus vaccine in healthy pregnant women. In addition, the study investigated the amount of vaccine induced antibodies which were transferred to the newborn.
- Conditions
- Streptococcal Infection, Gram-positive Bacterial Infection, Bacterial Infection
- Trial name
- NCT01446289
- Testing
- Group B Streptococcus Trivalent Vaccine
- Where
- 5 sites in Belgium, Canada
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Novartis
Dengue Virus Infection
Dengvaxia US Pregnancy Registry
The primary objective of this study is to assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women and their offspring(s) vaccinated with Dengvaxia during their pregnancy
- Trial name
- DNG00044 (NCT04486638)
- Testing
- Dengue Tetravalent Vaccine, Live
- Where
- Puerto Rico
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
sFlt1 Mediated Preterm Preeclampsia, Preeclampsia
A Study to Investigate the Safety, Pharmacodynamic and Pharmacokinetic Characteristics of CBP-4888 in Hospitalized Participants With Preterm Preeclampsia and Their Children up to 24 Months
This study is a dose finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous CBP-4888 in hospitalized participants with Preterm Preeclampsia receiving Standard of Care, Expectant…
- Conditions
- sFlt1 Mediated Preterm Preeclampsia, Preeclampsia, Preterm Preeclampsia
- Trial name
- NCT07282171
- Testing
- CBP-4888
- Where
- 3 sites in Australia
- Volunteers
- 60 people
- Sponsor
- Comanche Biopharma
Streptococcal Infections, Gram-Positive Bacterial Infections
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
The study compared the magnitude of the antibody response and safety of a GBS Trivalent Vaccine in HIV positive and HIV negative pregnant women and their offspring.
- Conditions
- Streptococcal Infections, Gram-Positive Bacterial Infections, Bacterial Infections
- Trial name
- NCT01412801
- Testing
- Group B streptococcus vaccine
- Where
- 2 sites in Malawi, South Africa
- Volunteers
- 270 people
- Sponsor
- Novartis Vaccines
Pregnancy Related, Pregnancy Complications
Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant…
- Conditions
- Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk
- Trial name
- NCT05739123
- Testing
- Relugolix-Containing Product
- Where
- United States
- Volunteers
- 728 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
Pregnant
DV2-HBV-27: Observational Pregnancy Registry
Purpose of the study is to evaluate pregnancy outcomes among women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy
- Trial name
- HBV-27 (NCT03664648)
- Testing
- HEPLISAV-B
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Multiple Sclerosis
A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
The purpose of this study is to provide information on maternal, fetal, and infant outcomes following exposure of ozanimod during pregnancy so that participants and physicians can weigh the benefits and risks of exposure to the…
- Trial name
- NCT05170126
- Where
- 3 sites in United States, Germany
- Volunteers
- 1,182 people
- Sponsor
- Bristol-Myers Squibb
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
Ulcerative Colitis
A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
- Trial name
- NCT05953402
- Where
- United States
- Volunteers
- 1,182 people
- Sponsor
- Bristol-Myers Squibb
Pregnancy Related, Narcolepsy
WAKIX® (Pitolisant) Pregnancy Registry
The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant…
- Trial name
- NCT05536011
- Testing
- Pitolisant, Comparator Products
- Where
- United States
- Volunteers
- 1,329 people
- Sponsor
- Harmony Biosciences Management, Inc.