Clinical trials: Exposure During Pregnancy
Postpartum Hemorrhage
In Vitro Evaluation of Spontaneous and Oxytocin-induced Contractility of Pregnant Human Myometrium During Exposure to Dexmedetomidine
Postpartum hemorrhage (PPH) remains to be one of the leading causes of maternal morbidity and mortality. It has been noted that an increasing number of PPH is attributed to the increased incidence of uterine atony.
- Trial name
- NCT05511415
- Testing
- Oxytocin, Dexmedetomidine
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Cystic Fibrosis (CF), Pregnancy
A Study of Females With CF Throughout Pregnancy and Post-partum, and Follow up of Their Offspring
In this study, investigators aim to study in detail the physical (including nutritional and pulmonary) and mental health of females with cystic fibrosis (CF) planning a pregnancy, during pregnancy, and in the early parenthood…
- Conditions
- Cystic Fibrosis (CF), Pregnancy, Infant, Newborn, Exposure During Pregnancy
- Trial name
- MATRIARCH_CF (NCT06797206)
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
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
Psoriasis, Pregnancy
Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live…
- Conditions
- Psoriasis, Pregnancy, Psoriatic Arthritis, Crohn Disease
- Trial name
- NCT02103361
- Testing
- Ustekinumab, Guselkumab
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- University of California, San Diego
Fetal Alcohol Spectrum Disorders
Dissecting the Genetics of Fetal Alcohol Spectrum Disorders
The purpose of this study is to help scientists understand why some people who were exposed to alcohol in the womb have special facial features but other people do not.
- Trial name
- DiGFASD (NCT04072809)
- Testing
- No intervention
- Where
- United States
- Volunteers
- 751 people, healthy volunteers welcome
- Sponsor
- Indiana University
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
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
HIV, Pregnancy
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
Study investigators developed and piloted a counselling intervention, Healthy Families-PrEP, that supports women to use HIV prevention strategies while trying for and during pregnancy.
- Conditions
- HIV, Pregnancy, Pre-Exposure Prophylaxis of HIV Infection
- Trial name
- HFPT (NCT06746675)
- Testing
- Healthy Families PrEP Counselling Intervention
- Where
- Uganda
- Volunteers
- 660 people, healthy volunteers welcome
- Sponsor
- Yale University
Radiation Exposure, Overactive Bladder
Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement
Fluoroscopy is performed when placing a lead during a sacral neuromodulation procedure. During lead placement, subjects will receive either conventional or experimental fluoroscopic settings.
- Conditions
- Radiation Exposure, Overactive Bladder, Urge Incontinence, Urgency-frequency Syndrome
- Trial name
- NCT04527445
- Testing
- Reduced radiation fluoroscopy, Conventional fluoroscopy
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Loma Linda University
Jaundice, Neonatal
Associations of Nighttime Light Exposure During Pregnancy With Neonatal Jaundice：a Multi-centre Prospective Study in China
Make a neonatal jaundiced nomogram on Chinese jaundice data by joinning the major neonate centers all around China.
- Trial name
- jaundice (NCT03805165)
- Where
- China
- Volunteers
- 2,977 people, healthy volunteers welcome
- Sponsor
- Guangdong Women and Children Hospital
Multiple Sclerosis, Clinically Isolated Syndrome
A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy
This study will evaluate the potential placental transfer of ocrelizumab in pregnant women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] whose last dose of…
- Trial name
- MINORE (NCT04998812)
- Testing
- Ocrelizumab
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
Chronic Idiopathic Constipation (CIC)
Post-Marketing Study of Prucalopride Safety In Pregnancy
This study collects information on pregnant women with ongoing constipation who took prucalopride and those who did not take prucalopride.
- Trial name
- NCT04869280
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Takeda
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
HIV/AIDS, Antiretroviral Therapy
Long Term Outcomes of Therapy in Women Initiated on Lifelong ART Because of Pregnancy in DR Congo
Despite the rapid adoption of the World Health Organization's 2013 guidelines, many children continue to be infected with HIV perinatally because of sub-optimal adherence to the continuum of HIV care in maternal and child health…
- Conditions
- HIV/AIDS, Antiretroviral Therapy, Pregnancy Outcomes, HIV-exposed Infants
- Trial name
- CQI-PMTCT (NCT03048669)
- Testing
- Continuous quality improvement
- Where
- Democratic Republic of the Congo
- Volunteers
- 5,053 people
- Sponsor
- Albert Einstein College of Medicine
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
Noise Exposure
Exposure to Intense and Prolonged Noises During Pregnancy
Hearing is an essential element for the development of language and conditions an appropriate cognitive, psychological and social development of children.
- Trial name
- GestaNoise (NCT05911204)
- Testing
- Questionnaire about intense noises exposure during pregnancy
- Where
- France
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Central Hospital, Nancy, France
Insomnia Disorder
Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy
- Trial name
- NCT06393504
- Testing
- Daridorexant, Non-orexin receptor antagonist insomnia medication, No insomnia medication
- Where
- United States
- Volunteers
- 2,095 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Maternal Complications, Pregnancy Complication
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their infant up to 12 months of life.
- Conditions
- Maternal Complications, Pregnancy Complication, Birth Outcomes, Adverse, Pregnancy
- Trial name
- NCT06113237
- Testing
- Epidiolex
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 50 people
- Sponsor
- Jazz Pharmaceuticals
Rheumatoid Arthritis -Exposure During Pregnancy
An Observational Study on Sarilumab-exposed Pregnancies
Primary Objective: To evaluate the relative risk of major structural birth defects, specifically a pattern of anomalies, in sarilumab-exposed pregnancies compared to disease-matched unexposed pregnancies.
- Trial name
- NCT03378219
- Testing
- Sarilumab SAR153191 (REGN88)
- Where
- 2 sites in United States, Canada
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Sanofi
PTSD
Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study
The majority of women with perinatal posttraumatic stress disorder (PTSD) do not receive mental health treatment despite the documented associations between PTSD and adverse pregnancy outcomes; this is likely due to workforce…
- Trial name
- TAPS (NCT05486793)
- Testing
- Written Exposure Therapy (WET), Emotion Focused Supportive Therapy (EFST)
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Boston University