Clinical trials: Exposure During Pregnancy
Pregnancy Related
Pregistry International Pregnancy Exposure Registry (PIPER)
The aims of the Pregistry International Pregnancy Exposure Registry (PIPER) are to provide early signals of risk after prenatal exposure to medical products and to define boundaries of safety for medical products.
- Trial name
- PIPER (NCT05352256)
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Pregistry
Covid19
COVID-19 Vaccines International Pregnancy Exposure Registry
The objective of the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) is to evaluate obstetric, neonatal, and infant outcomes among women vaccinated during pregnancy with a COVID-19 vaccine.
- Trial name
- C-VIPER (NCT04705116)
- Testing
- COVID-19 vaccine
- Where
- United States
- Volunteers
- 1,184 people, healthy volunteers welcome
- Sponsor
- Pregistry
Birth Defect, Spontaneous Abortions
Nplate® Pregnancy Exposure Registry
US study to estimate the prevalence at birth of major birth defects (ie, those that cause significant functional or cosmetic impairment, require surgery, or are life-limiting) in children born to mothers who have received Nplate®…
- Conditions
- Birth Defect, Spontaneous Abortions, Low Birth Weight
- Trial name
- NPER (NCT02090088)
- Testing
- Not applicable- observational study
- Volunteers
- 4 people
- Sponsor
- Amgen
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
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
Diphtheria
A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.
The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in a maternal immunization program in Brazil.
- Trial name
- NCT02757950
- Testing
- Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]
- Where
- Brazil
- Volunteers
- 2,462 people
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
Safety of 4CMenB Exposure During Pregnancy
4CMenB was approved by the Food and Drug Administration (FDA) in the United States in January 2015 for people aged 10 through 25 years of age.
- Trial name
- NCT02640677
- Testing
- 4CMenB
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- GlaxoSmithKline
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
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
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
Meningococcal Disease
A Study to Learn About the Safety of PENBRAYA During Pregnancy
This study is a pregnancy registry designed to learn more about the safety of the study vaccine PENBRAYA (a vaccine that protects against meningitis causing bacteria) when it is given during pregnancy or within 30 days before the…
- Trial name
- NCT07768163
- Testing
- PENBRAYA
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Pfizer