Clinical trials: Exposure During Pregnancy
Atopic Dermatitis, Eczema
Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
The goal of this observational study is to learn about exposure to tralokinumab during pregnancy, as well as atopic dermatitis (AD) during pregnancy.
- Trial name
- PROTECT (NCT05938478)
- Testing
- Tralokinumab
- Where
- United States
- Volunteers
- 900 people
- Sponsor
- University of California, San Diego
Pregnancy Related, Benzodiazepines Causing Adverse Effects in Therapeutic Use
Maternal and Neonatal Outcomes Following Exposure to Benzodiazepines During Pregnancy
This is a nationwide cohort study to assess maternal and neonatal outcomes following exposure to benzodiazepines during pregnancy.
- Conditions
- Pregnancy Related, Benzodiazepines Causing Adverse Effects in Therapeutic Use, Congenital Anomaly
- Trial name
- NCT04856436
- Testing
- Benzodiazepine
- Where
- South Korea
- Volunteers
- 3,094,227 people, healthy volunteers welcome
- Sponsor
- Sungkyunkwan University
Phthalate Exposure, Preeclampsia
The Relationship of Phthalate Exposure During Pregnancy and Preeclampsia
Phthalates are a group of ubiquitous synthetic endocrine-disrupting chemicals. Fetal and neonatal periods are particularly susceptible to endocrine disorders, which prenatal exposure to phthalates causes.
- Conditions
- Phthalate Exposure, Preeclampsia, Estrogen, Progestin
- Trial name
- NCT04777929
- Testing
- test Phthalates, estrogen and progesterone
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
Cadmium, Placenta
Cadmium Exposure During Pregnancy and Fetal Growth
Cadmium is a toxic heavy metal naturally present in the environment, whose human exposure has increased over recent decades due to diffuse anthropogenic contamination, particularly related to industrial activities and the use of…
- Conditions
- Cadmium, Placenta, Fetal Growth, Birth Weight
- Trial name
- CADNAT (NCT07855237)
- Testing
- maternal blood samples, Placental tissue samples, maternal urine samples
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Radiation Exposure, Urolithiasis
Study of the Patient Radiation Dose During Five Endourological Procedures
In the medical world more and more procedures are performed with the use of ionizing radiation (x-ray), both diagnostic and therapeutic.
- Trial name
- PRDE (NCT06384105)
- Testing
- frames per second
- Where
- 2 sites in Belgium
- Volunteers
- 870 people, healthy volunteers welcome
- Sponsor
- Universiteit Antwerpen
Multiple Sclerosis, Pregnancy
Fampridine Pregnancy Exposure Registry
This is a global pregnancy registry to evaluate the outcomes of pregnancy in women with multiple sclerosis who have been exposed to prolonged-release fampridine since the first day of their last menstrual period prior to…
- Trial name
- NCT01532154
- Testing
- Fampridine
- Where
- France
- Volunteers
- 1 people
- Sponsor
- Biogen
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
Neonatal Abstinence Syndrome
Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain
The long term goals of our research are to establish the best pharmacological treatment for NAS and determine how pharmacologic treatment of NAS affects long-term developmental outcomes.
- Trial name
- No-POPPY (NCT03396588)
- Testing
- Clonidine, Morphine
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Henrietta Bada
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
Hypercholesterolemia
Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
Primary Objective: To estimate the overall combined rate of major structural birth defects in infants of mothers with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) exposed to Praluent®…
- Trial name
- NCT03379558
- Testing
- ALIROCUMAB SAR236553 (REGN727)
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
General Anaesthesia During Pregnancy
Intelligence and Neurodevelopmental Disorders After Prenatal Exposure to General Anaesthesia
Every year in the European Union, thousands of babies are exposed to anaesthesia before they are born because their mothers need surgery during pregnancy.
- Trial name
- PAE-IQ (NCT06633406)
- Testing
- Age-appropriate Wechsler Intelligence Test, Disruptive Behavior Disorders Rating Scale, Social Responsiveness Scale
- Where
- 3 sites in Belgium
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
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
Fever, Labor Pain
Maternal Epidural Steroids and Hyperthemia
The purpose of this study is to look to see if adding steroids to an epidural reduces the chances of having a fever in labor, and protects the baby from exposure to inflammation.
- Conditions
- Fever, Labor Pain, Complication of Anesthesia During Pregnancy, Unspecified
- Trial name
- NCT02212210
- Testing
- Methylprednisolone, Normal saline
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- Medical University of South Carolina
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
Sleep Initiation and Maintenance Disorders, Pregnancy
A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population
The primary purpose of the study is to compare the occurrence of major congenital malformations (MCMs) among live births between women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and women with…
- Trial name
- NCT06744673
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 861 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
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
Post Traumatic Stress Disorder
Feasibility Trial of Narrative Exposure Therapy (NET) for Posttraumatic Stress Disorder (PTSD) During Pregnancy
Posttraumatic stress disorder (PTSD) affects up to 35% of pregnant trauma survivors. Moreover, prenatal PTSD rates are up to 4 times higher among communities of color compared to white populations.
- Trial name
- NET (NCT04525469)
- Testing
- Narrative Exposure Therapy
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Rush University Medical Center
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
Migraine
Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) or Qulipta (Atogepant) During Pregnancy
Migraine is a common neurological disorder typically characterized by attacks of throbbing or pulsating headache on one side of the head of moderate to severe pain intensity.
- Trial name
- EMPRESS (NCT05158894)
- Where
- 2 sites in United States, Canada
- Volunteers
- 1,884 people
- Sponsor
- AbbVie
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