Clinical trials: Exposure During Pregnancy
HIV Infections, Exposure During Pregnancy
Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers ( NEUROPSY-HEU )
Main objective: to evaluate the executive functioning of the HIV exposed uninfected children (HEU) versus children from the same socio-economic and cultural environment, not infected or affected by HIV.
- Conditions
- HIV Infections, Exposure During Pregnancy, Neurophysiologic Abnormality, Executive Dysfunction
- Trial name
- NEUROPSY-HEU (NCT04108728)
- Testing
- BRIEF SCORE AT INCLUSION
- Where
- 3 sites in France
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Nantes University Hospital
Pregnancy
AMEVIVE® Pregnancy Registry
This is an observational, exposure-registration and follow-up study, to be conducted in the United States (US). The AMEVIVE® Pregnancy Exposure Registry is designed to monitor pregnant subjects and fetuses exposed to AMEVIVE® in…
- Trial name
- NCT00342862
- Testing
- Amevive exposure
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Astellas Pharma Inc
Cystic Fibrosis
CFTR Modulators in Pregnancy and Postpartum
Observational study on women with Cystic Fibrosis treated with CFTR modulators during pregnancy and postpartum and their children.
- Trial name
- NCT06302270
- Where
- Sweden
- Volunteers
- 75 people
- Sponsor
- Region Stockholm
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
HIV, Infant Exposure to Efavirenz
Option B+: Study on Safety, Viral Suppression, and Survival on Second Line ART
To characterize safety, durability, antiretroviral treatment (ART) resistance, and clinical outcomes for mothers and infants exposed to the efavirenz-based Option B+ regimen for Prevention of Mother to Child Transmission (PMTCT)…
- Trial name
- S4 (NCT02249962)
- Where
- Malawi
- Volunteers
- 12,011 people
- Sponsor
- University of North Carolina, Chapel Hill
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
Psoriasis (PsO)
A Study to Assess Deucravacitinib Safety in Pregnancy
The purpose of this study is to assess pregnancy and infant outcomes among pregnant participants enrolled in an established North American pregnancy registry (Organization of Teratology Information Specialists [OTIS]) who were…
- Trial name
- NCT07017699
- Testing
- Deucravacitinib, Other systemic treatments for PsO
- Where
- United States
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Non-birthing Partner Vaccination in Pregnancy, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Assessing Interventions to Increase Tdap Acceptance for Non-birthing Partners in Pregnancy
The goal of this randomized control trial is to assess if prenatal vaccine education and in-office vaccination administration for non-birthing partners of pregnant patients increases Tdap vaccination rates compared to usual care.
- Conditions
- Non-birthing Partner Vaccination in Pregnancy, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, Vaccine Exposure During Pregnancy
- Trial name
- ITAPP (NCT06135636)
- Testing
- Education, Vaccine administration
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Women and Infants Hospital of Rhode Island
Kidney Calculi, Radiation Exposure
Safety and Efficacy of Fluoroscopy-free Technique During Retrograde Intrarenal Surgery for Renal Stones
Aiming to reduce radiation exposure to patients and physicians, the investigators conduct this study protocol to evaluate the possibility of performing retrograde intrarenal surgery (RIRS) under direct visualization without…
- Conditions
- Kidney Calculi, Radiation Exposure, Retrograde Intrarenal Surgery
- Trial name
- NCT05269108
- Testing
- Fluoroscopy-free RIRS, Standard RIRS
- Where
- Egypt
- Volunteers
- 503 people
- Sponsor
- Al-Azhar University
Constipation, Pregnancy
A Study to Assess Maternal and Fetal Outcomes After Taking Prucalopride During Pregnancy
This study will collect information on pregnant women diagnosed with constipation from the two large health care insurance claims records. It will include the following groups: Those who took prucalopride.
- Trial name
- NCT04961840
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Takeda
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
Vaccine Exposure During Pregnancy
PREHEVBRIO Pregnancy Outcomes Registry
The registry is an observational surveillance program designed to recruit and encourage participation of women who were exposed to PREHEVBRIO® hepatitis B vaccine during pregnancy and to collect and analyze information related to…
- Trial name
- NCT06097312
- Testing
- Data collection
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- VBI Vaccines Inc.
Vaccine Adverse Reaction
Peri-conceptional or Pregnancy Exposure of Vaccination and the Risk of Adverse Pregnancy Outcomes
Uing data from a population based cohort in China, we will conduct retrospective cohort study to evaluate the risk of vaccine (e.g., HPV/influenza/rabies vaccine) administered during pregnancy (especially during first trimester)…
- Trial name
- NCT06180447
- Testing
- Hepatitis B vaccine, rabies vaccine, HPV vaccine, influenza vaccine
- Where
- China
- Volunteers
- 150,000 people
- Sponsor
- Sun Xin
Multiple Sclerosis
Safety of Exposure to Natalizumab During Pregnancy
Multiple sclerosis (MS) preferentially affects young adults with a female predominance. MS is not associated with an increased risk of complications or abnormal pregnancy outcomes.
- Trial name
- BABYZUMAB-2 (NCT05209815)
- Testing
- Questionnaire
- Where
- 27 sites in France, Martinique
- Volunteers
- 68 people
- Sponsor
- University Hospital, Bordeaux
Childhood Obesity Prevention
Anthropometric Outcomes of a Mobile Health Intervention for Eating Behaviour and Lifestyle in Infancy
Lifestyle, activity, and feeding behaviours during early childhood set the foundation for subsequent lifelong metabolic health as an adult.
- Trial name
- NCT06457750
- Testing
- Feeding, Lifestyle, Activity Goals (FLAGs) Digital Health Application
- Where
- Singapore
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- KK Women's and Children's Hospital
Exposure During Pregnancy
A Study to Describe Mothers' and Babies' Outcomes After Exposure to HyQvia During Pregnancy
The main aim of this study is to provide further information on the safety profile of HyQvia during pregnancy. This will be done by checking the characteristics of the mother and their babies.
- Trial name
- NCT05803200
- Testing
- No intervention
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Takeda
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
Pregnancy
VIBATIV Pregnancy Registry
The purpose of this registry is to evaluate the outcome of pregnancy in women exposed to VIBATIV at any time during pregnancy. There are no mandated physician visits for the registry.
- Trial name
- NCT01130324
- Testing
- VIBATIV
- Where
- United States
- Sponsor
- Cumberland Pharmaceuticals
Prematurity, Oxidative Pulmonary Injury
The Effect of Oxygen Exposure During Newborn Resuscitation on Lung Injury
Hypothesis: In this feasibility study, hyperoxemia, as approximated by transcutaneous hemoglobin saturation with oxygen (Sp02), at the time of birth will cause sustained pulmonary oxidative stress as demonstrated by elevation of…
- Trial name
- NCT00355875
- Testing
- titration of oxygen during resuscitation
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University of Calgary
Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome
RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure
Although the adverse effects associated with prenatal alcohol exposure (PAE) are well known, many women continue to drink heavily during pregnancy, putting their infants at risk for fetal alcohol spectrum disorders.
- Trial name
- NCT04395196
- Testing
- Choline bitartrate
- Where
- South Africa
- Volunteers
- 288 people, healthy volunteers welcome
- Sponsor
- Wayne State University