Clinical trials: Pregnancy Outcomes
Pregnancy, Down Syndrome
Comparison of Aneuploidy Risk Evaluations
This is a prospective, multi-center observational study designed to compare the test results of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening for fetal chromosome abnormalities in…
- Conditions
- Pregnancy, Down Syndrome, Edwards Syndrome, Patau Syndrome
- Trial name
- CARE (NCT01663350)
- Where
- 26 sites in United States
- Volunteers
- 3,000 people
- Sponsor
- Verinata Health, Inc.
Urinary Bladder, Overactive
An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder Participants
The objective of this study is to evaluate the efficacy of oxybutynin chloride oral osmotic therapeutic system (OROS) on patient-reported outcomes after 12 weeks of treatment by dose escalation in participants with overactive…
- Trial name
- NCT00613327
- Testing
- Oxybutynin chloride OROS
- Volunteers
- 345 people
- Sponsor
- Janssen Korea, Ltd., Korea
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
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.
Multiple Sclerosis
An Observational Study on Teriflunomide-exposed Pregnancies
Primary Objective: To evaluate any potential increase in the risk of major birth defects, in the first year of life, in teriflunomide-exposed pregnancies.
- Trial name
- NCT03198351
- Testing
- Teriflunomide (HMR1726)
- Where
- 2 sites in United States, Canada
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Sanofi
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
End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD)
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
- Conditions
- End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy
- Trial name
- TRANSFORM (NCT01950819)
- Testing
- Induction therapy, Corticosteroids, EVR+rCNI
- Where
- 184 sites in United States, Argentina and 40 more
- Volunteers
- 2,037 people
- Sponsor
- Novartis Pharmaceuticals
Transthyretin Amyloidosis
The Eplontersen Pregnancy and Lactation Outcomes Study
The overall objective of this DPSS is to describe the occurrence of pregnancy and maternal complications, adverse effects on the developing fetus and neonate, and adverse effects on the infant associated with exposure to…
- Trial name
- EPPRO (NCT07205666)
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- AstraZeneca
Gestational Diabetes Mellitus in Pregnancy
Impact of Oral Probiotic Blend on Pregnancy Outcome
The aim of this study is, to investigate the effect of oral intake of Lactobacillus rhamnosus GG (ATCC 53103), Lactobacillus crispatus Lbv88, Lactobacillus rhamnosus Lbv96, Lactobacillus jensenii Lbv116 Lactobacillus gasseri…
- Trial name
- NCT04009889
- Testing
- capsule containing a probiotic blend of 5 different Lactobacilli, capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.
- Where
- Germany
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- i-Health, Inc.
Herpes Genitalis
A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes
A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.
- Trial name
- NCT00486200
- Testing
- ASP2151, valacyclovir
- Where
- 25 sites in United States
- Volunteers
- 695 people
- Sponsor
- Astellas Pharma Inc
Coronary Artery Disease
The Use of Aging Biomarkers to Predict Adverse Outcomes After Cardiac Surgery
Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI.
- Trial name
- NCT02496234
- Where
- United States
- Volunteers
- 186 people
- Sponsor
- Sapere Bio
Influenza, Human, Pregnancy
Afluria Pregnancy Registry
The study is a population based prospective cohort study designed to collect data on pregnancy outcomes and events of interest among women immunized with Afluria during pregnancy.
- Conditions
- Influenza, Human, Pregnancy, Birth Defect
- Trial name
- NCT03442582
- Testing
- Afluria Influenza Vaccine
- Where
- United States
- Volunteers
- 490 people, healthy volunteers welcome
- Sponsor
- Seqirus
Respiratory Syncytial Virus, Respiratory Tract Diseases
Impact and Effectiveness of ABRYSVO® Vaccination During Pregnancy
This study will be conducted in collaboration with a research network of independent hospital sites to evaluate the vaccine effectiveness (VE) and impact of ABRYSVO vaccination during pregnancy in a real-world population over…
- Trial name
- BERNI (NCT06647654)
- Testing
- ABRYSVO
- Where
- Argentina
- Volunteers
- 1 people
- Sponsor
- Pfizer
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
Stress Urinary Incontinence
Artificial Urinary Sphincter Clinical Outcomes
To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.
- Trial name
- AUSCO (NCT04088331)
- Testing
- AMS 800 Artificial Urinary Sphincter
- Where
- 18 sites in United States, Australia
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Pregnancy, Obesity
A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy
This is an observational, prospective Wegovy (semaglutide 2.4 milligram [mg]) Pregnancy Registry Study. The aim of this study is to compare the maternal, foetal, and infant outcomes of pregnant women who are exposed to Wegovy…
- Conditions
- Pregnancy, Obesity, Overweight
- Trial name
- NCT05872022
- Testing
- No Intervention
- Where
- 3 sites in United States, Spain and 1 more
- Volunteers
- 728 people
- Sponsor
- Novo Nordisk A/S
Uterine Fibroid
Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids
The goal of this Registry Study is to capture clinical pregnancy outcomes and fibroid treatment background data for any subject post-Exablate treatment for their symptomatic fibroids.
- Trial name
- NCT05386615
- Testing
- Body System - Functional
- Where
- 6 sites in United States, China
- Volunteers
- 200 people
- Sponsor
- InSightec
Maternal Outcomes, Infant Outcomes
Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy
The primary objectives of this study are: In infants of women exposed to SPIKEVAX during pregnancy, to assess: If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of major congenital…
- Conditions
- Maternal Outcomes, Infant Outcomes, Pregnancy
- Trial name
- NCT06369272
- Where
- United States
- Volunteers
- 1,192 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
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
Sickle Cell Disease
Crizanlizumab Pregnancy Outcomes Intensive Monitoring
This was a non-interventional study to evaluate pre-specified pregnancy and infant outcomes in women treated with crizanlizumab during pregnancy or within 105 days before the last menstrual period (LMP).
- Trial name
- PRIM (NCT07554547)
- Where
- Switzerland
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals