Clinical trials: Prenatal Exposure, open to volunteers
Coronary Heart Disease, Acute Myocardial Infarction
Twenty-year Follow-up of the Inter99 Cohort
Being born small increases your risk of developing Type 2 diabetes (T2D) with age. Furthermore, data even suggest that some of the diseases ("complications") in the eyes, kidneys, nerves, liver, blood vessels and heart often seen…
- Conditions
- Coronary Heart Disease, Acute Myocardial Infarction, Cardiovascular Diseases, Type 2 Diabetes
- Trial name
- NCT05166447
- Where
- Denmark
- Volunteers
- 4,000 people
- Sponsor
- Bispebjerg Hospital
Hepatitis C
The Treatment in Pregnancy for Hepatitis C ("TiP-HepC") Registry
Clinical interventions to reduce the risk of vertical transmission of hepatitis C virus (HCV) infection from mother to infant are highly limited.
- Trial name
- TiP-HepC (NCT05368974)
- Testing
- Direct Acting Antivirals
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- The Task Force for Global Health
Fetal Developmental Abnormality, Fetal Development
Scottish Advanced Fetal Research Study
In-utero exposure to drugs and chemicals through maternal smoking, alcohol use, drug abuse, prescription medicines and occupational/lifestyle exposures is widespread.
- Conditions
- Fetal Developmental Abnormality, Fetal Development, Human, Life Style
- Trial name
- SAFeR (NCT04613583)
- Testing
- SAFeR fetuses
- Where
- United Kingdom
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- University of Aberdeen
Pregnancy
Prenatal Exposure Effects Psychophysiology Study
The purpose of the study is to understand the biology and behavior of early mother-infant attachment, and to investigate how it may be affected by prenatal substance exposures.
- Trial name
- PEEPS (NCT01134770)
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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
Gonad Regulating Hormone Adverse Reaction, Analgesic Adverse Reaction
Neurobehavioral Development in Toddlers and Preschoolers in Relation to Prenatal Exposure of Mild Analgesics (NeuroToP - a COPANA Follow up)
Fundamental aspects of both neurological and reproductive function are established in fetal life, and there is a present increased awareness of the potential effects of fetal exposures on neurodevelopmental and reproductive…
- Conditions
- Gonad Regulating Hormone Adverse Reaction, Analgesic Adverse Reaction, Developmental Disability, Adhd
- Trial name
- NeuroToP (NCT07316387)
- Where
- Denmark
- Volunteers
- 685 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Developmental Delay
Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure
The INTACT trial is a multisite pilot feasibility study aimed at testing the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids.
- Trial name
- INTACT (NCT06423664)
- Testing
- Play and Learn Strategies (PALS) Program
- Where
- 3 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- IDeA States Pediatric Clinical Trials Network
Fetal Alcohol Syndrome
In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions
This study aims to validate that PLGF is a biomarker of cerebral lesions and therefore of secondary developmental disorders and disabilities that will be best diagnosed at 2 and 6 years of age.
- Trial name
- ALCOBRAIN (NCT03371641)
- Testing
- ASQ parental questionnaire, Development scales, Scale of Conners
- Where
- France
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University Hospital, Rouen
Brain Development, Choline Nutrition
Pilot Study of Prenatal Choline Supplementation
A double-blind, randomized, placebo-controlled trial (RCT; NCT04395196) of prenatal choline supplementation is ongoing (1) to assess the effectiveness of maternal choline supplementation during pregnancy to mitigate effects of…
- Trial name
- NCT07699393
- Testing
- Choline bitartrate
- Where
- South Africa
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Wayne State University
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
Type 1 Diabetes, Pregnancy in Diabetic
PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life
This research study is called 'PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life: The PROMISE Study'.
- Trial name
- PROMISE (NCT06141434)
- Where
- 4 sites in United States
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Maternal Distress, Child Development
In Vitro Fertilization (IVF) and Prenatal Effects Independent of Genetics
This study examines how maternal stress during pregnancy affects infant brain and behavioral development, focusing on whether these effects are due to the prenatal environment or shared genes.
- Trial name
- NCT07296107
- Testing
- Prenatal maternal psychosocial and biological assessment protocol
- Where
- United States
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Columbia University
Urinary Stone
2D:4D Digit Ratio and Urinary Stone Disease
This prospective observational case-control study will investigate whether the 2D:4D digit ratio is associated with urinary stone disease.
- Trial name
- NCT07736924
- Where
- Turkey (Türkiye)
- Volunteers
- 300 people
- Sponsor
- Emrah Kızılay
Erosive Esophagitis, Heartburn
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
The main objective of the study is to compare the maternal, fetal, and infant outcomes of pregnant women who are exposed to vonoprazan during pregnancy with outcomes of an internal comparison cohort of pregnant women who are…
- Conditions
- Erosive Esophagitis, Heartburn, Symptomatic Non-erosive Gastroesophageal Reflux Disease, Helicobacter Pylori Infection
- Trial name
- NCT06660342
- Testing
- Vonoprazan
- Where
- United States
- Volunteers
- 728 people
- Sponsor
- Phathom Pharmaceuticals, Inc.
Fetal Alcohol Spectrum Disorders, Attention Deficit Hyperactivity Disorder
Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure
This is an open-label trial of trigeminal nerve stimulation (TNS) for children aged 8-12 years with attention deficit hyperactivity disorder (ADHD) putatively due to prenatal alcohol exposure (PAE).
- Trial name
- TNS-PAE (NCT06847165)
- Testing
- Trigeminal Nerve Stimulation (TNS)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of California, Los Angeles
Perinatal Mental Health, Gestational Weight Gain
Healthy Adaptation to Pregnancy, Postpartum and Parenthood
Healthy Adaptation to Pregnancy, Postpartum and Parenthood (HAP3) The HAP3 study is evaluating a new digital support program for pregnant women and their partners.
- Conditions
- Perinatal Mental Health, Gestational Weight Gain, Postpartum Weight Retention, Child Development
- Trial name
- HAP3 (NCT07837193)
- Testing
- HAP3 Family App
- Where
- Belgium
- Volunteers
- 572 people, healthy volunteers welcome
- Sponsor
- KU Leuven
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
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
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
Secondhand Smoke Exposure
A Study to Test Feasibility and Acceptability of an Intervention Program Aiming to Reduce Prenatal Secondhand Smoke Exposure
This pilot study assess the feasibility and acceptability of the "First Breath" digital behavioral intervention aiming to reduce prenatal SHS exposure.
- Trial name
- First Breath (NCT07003282)
- Testing
- The intervention includes 1) the "First Breath" app, 2) reminders during the follow-up period and 3) only for women- cotinine concentration measurement (a biomarker of secondhand smoke exposure)
- Where
- Israel
- Volunteers
- 160 people
- Sponsor
- Hebrew University of Jerusalem