Clinical trials: Maternal Exposure, open to volunteers
Mother-Child Relations, Substance Use
Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparison of Breaking the Cycle and Maxxine Wright
The goal of this clinical trial is to compare the effectiveness of the Breaking the Cycle (BTC) and Maxxine Wright (MW) programs in substance-involved mothers and their children.
- Trial name
- NCT05768815
- Testing
- Breaking the Cycle Program, Maxxine Wright Program
- Where
- 2 sites in Canada
- Volunteers
- 100 people
- Sponsor
- University of Ottawa
Breastfeeding
Mycotoxins in Mothers Milk in Israel
Some plant pathogen fungi may develop in grains, nuts and dry foodstuff during their storage. They secrete toxins which are very resistant and persistent. The toxins enter the human body through the food.
- Trial name
- NCT05371106
- Testing
- exposure to mycotoxins
- Where
- Israel
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Assaf-Harofeh Medical Center
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
Dental Caries in Children, Diet Habit
Maternal Control of the Child's Feeding, Child's Eating Behavior and Early Childhood Caries in Preschoolers
Dental caries in children is considered one of the most prevalent oral diseases of this age group, leading to significant manifestations presenting as pain, interference with feeding, higher risk of developing dental caries in…
- Conditions
- Dental Caries in Children, Diet Habit, Dietary Exposure, Eating Behavior
- Trial name
- NCT06898918
- Where
- Egypt
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Ain Shams University
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
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
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
Pregnancy Related
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12…
- Trial name
- NCT06258902
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Ipsen
Children Born to Mothers Enrolled in the TOCOPROM Trial
6-year Outcomes in Children After Nifedipine vs Placebo for Preterm Prelabor Rupture of Membranes at 22-33 Weeks
The purpose of this study is to evaluate the neurodevelopment at age 6 of children born to women with preterm prelabor rupture of membranes at 22 to 33 weeks of gestation, after antenatal exposure to nifedipine vs placebo.
- Trial name
- TOCOKIDS (NCT07146451)
- Testing
- Self-administered parental questionnaire, A short psychological assessment performed online
- Where
- France
- Volunteers
- 480 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Friedreich Ataxia
A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies
In this study, researchers will learn more about the safety of BIIB141, also known as omaveloxolone or SKYCLARYS. This is a drug available for doctors to prescribe for people with Friedrich's Ataxia, also known as FA.
- Trial name
- NCT06628687
- Testing
- Omaveloxolone
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Biogen
Child Development, Cannabis Use
Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development
The goal of this study is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women who have used cannabis products during the current pregnancy improves the offspring\'s brain-related…
- Trial name
- NCT06379971
- Testing
- Choline
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Pregnancy Related, Atopic Dermatitis
Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population
This observational (enrollment into the registry while the pregnancy is ongoing) study is being conducted to compare the frequency of major congenital malformation (MCM)s among infants of women exposed to ruxolitinib cream during…
- Trial name
- OPERA-1 (NCT06259669)
- Testing
- Ruxolitinib Cream
- Where
- United States
- Volunteers
- 958 people
- Sponsor
- Incyte Corporation
Offspring Exposed to GDM and Control
PREG - Offspring: Investigation of Children From Mothers With and Without Gestational Diabetes
Gestational diabetes is the most common complication during pregrancy. With a screening between week 24 and 28 of gestation women with gestational diabetes can be identified and treated.
- Trial name
- NCT04722900
- Testing
- intrauterine exposure to elevated glucose levels
- Where
- Germany
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University Hospital Tuebingen
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
Malnutrition Pregnancy, Malnutrition in Children
Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories
Malnutrition in women of reproductive age remains a public health concern in Sub-Saharan Africa (SSA). Malnutrition during pregnancy affects foetal growth with a tendency of the exposed infants to also develop it.
- Conditions
- Malnutrition Pregnancy, Malnutrition in Children, Malnutrition (Calorie), Environmental Enteric Dysfunction
- Trial name
- UZBCS-2 (NCT07195006)
- Testing
- Malnutrition in pregnancy as exposure, Poor WASH living conditions as exposure
- Where
- Zimbabwe
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- University of Zimbabwe