Clinical trials: Maternal Exposure
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
Pregnancy Related, Immune-mediated Diseases
Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System Development
What is this project about? This project aims to better understand how the immune system develops in babies whose mothers received immunomodulatory treatments during pregnancy.
- Trial name
- NEWbornIMMPACT (NCT07033663)
- Testing
- Monoclonal antibody
- Where
- 3 sites in Spain
- Volunteers
- 90 people
- Sponsor
- Fundació Sant Joan de Déu
Offspring of Pre-eclamptic Mothers
Cardiovascular Risk in Infants Exposed to Pre-eclampsia in Utero
An increasing number of scientific publications show that high blood pressure is being described in younger and younger children of African ancestry.
- Trial name
- NCT05091827
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- Walter Sisulu University
Prenatal Stress
Measuring Outcomes of Maternal COVID-19-related Prenatal Exposure
The rapidly spreading coronavirus Covid-19 pandemic is a major concern worldwide and Italy is at the forefront of this emergency.
- Trial name
- MOM-COPE (NCT04540029)
- Testing
- Maternal stress
- Where
- Italy
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
Mother to Child HIV Transmission
HIV Diagnosis and Treatment at Birth for Newborn With High Risk HIV Exposure
Principal objective Assess the operational efficacy of a strategy combining early diagnosis and preventive antiretroviral treatment systematically reinforced from the birth* among infants at high risk of infection with HIV** .
- Trial name
- DIAVINA (NCT03642704)
- Testing
- Reinforced preventive ARV therapy
- Where
- Guinea
- Volunteers
- 56 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Fabry Disease, Pregnancy
Maternal and Postnatal Outcomes Study (MOS): A Global Observational Registry Assessing the Safety of Elfabrio® in Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding
The goal of this observational registry is to evaluate the safety and outcomes of pregnancy and lactation in women with Fabry disease who are exposed to pegunigalsidase alfa within 30 days prior to conception and/or during…
- Conditions
- Fabry Disease, Pregnancy, Pregnancy Complications
- Trial name
- MOS (NCT06941025)
- Testing
- Not applicable- observational study
- Where
- 5 sites in United States, Germany and 3 more
- Volunteers
- 10 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Health Preterm Infants With no Active Disease, Human Milk Nutrition
The Effect of Exposure to Maternal Human Milk Odor on Physiological State of Preterms.
Mammalian fetal sensory development comes in an invariant series, with the tactile/kinesthetic and chemosensory systems the earliest functioning and responsive to stimulation, implicating the importance of these foundational…
- Conditions
- Health Preterm Infants With no Active Disease, Human Milk Nutrition, Incubator Stay
- Trial name
- NCT01012505
- Testing
- adding pad with maternal milk in hte incubator
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Sheba Medical Center
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
Atopic Dermatitis
Prenatal Exposure to Emerging Contaminants and Children's Atopic Dermatitis
This prospective cohort study aims to investigate the association between prenatal blood levels of Emerging Contaminants and the five-year incidence of atopic dermatitis (AD) in offspring.
- Trial name
- PECCAD (NCT06316609)
- Testing
- Gestational Exposure to Emerging Contaminants (ECs)
- Where
- China
- Volunteers
- 456 people
- Sponsor
- Children's Hospital of Fudan University
Metabolic Diseases, Neurological and Mental Health Conditions
Growing Up in Singapore Towards Healthy Outcomes
This study aims to examine the role of genetic and epigenetic factors, maternal nutrition, lifestyle, emotional health, and other environmental factors in pregnancy or postpartum period that can influence future maternal risk of…
- Conditions
- Metabolic Diseases, Neurological and Mental Health Conditions, Genetic Predisposition, Skin Condition
- Trial name
- GUSTO (NCT01174875)
- Where
- Singapore
- Volunteers
- 1,247 people, healthy volunteers welcome
- Sponsor
- National University Hospital, Singapore
Maternal Exposure During Pregnancy
Effect of Dietary Counseling During Pregnancy on Infant Birthweight in Mangochi , Malawi
High neonatal mortality rates accounts for a substantial early loss of lives in Malawi; and has thus been a hindrance for Malawi to eradicate child deaths.
- Trial name
- NCT03136393
- Testing
- Community based dietary counselling, Community based antenatal counselling
- Where
- Malawi
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of Oslo
Violence, Domestic
Healing Circles: An Intervention for Canadian Indigenous Mothers & Children Affected by IPV
Evaluation of Mother's Empowerment Program and Kid's Club Program adapted specifically for Indigenous mothers and children affected by intimate partner violence in Canada
- Trial name
- NCT04235335
- Testing
- Indigenous Mother's Empowerment Program & Indigenous Kid's Club Program
- Where
- Canada
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- University of Manitoba
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
Hiv
Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)
The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the…
- Trial name
- PrEP-PP (NCT03826199)
- Testing
- TDF-FTC, Counselling on PrEP in antenatal and postnatal care
- Where
- South Africa
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
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
Domestic Violence, Child Abuse
Cluster RCT of Embedded Parenting Intervention to Prevent Recurrence and Reduce Impairment in Young Children Exposed to Domestic Violence
The current cluster randomized trial examines the efficacy of embedding two different parenting interventions within child protection services for young children (0 to 4) who have been exposed to domestic violence and who are at…
- Trial name
- SafeUnderstood (NCT03198429)
- Testing
- Caring Dads, Mothers in Mind
- Where
- 2 sites in Canada
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Toronto
ThermoSpot Accuracy and Maternal Recognition
Evaluation of Thermospot Accuracy in Nigerian Infants Exposed to Ambient Temperature and Validation of Maternal Readings and Responses
This project will focus on testing the accuracy of ThermoSpot -a low-cost, color-based, temperature indicator in estimating the body temperature of Nigerian babies exposed to ambient temperature conditions.
- Trial name
- Thermospot (NCT02968524)
- Where
- Uganda
- Volunteers
- 492 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
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
Neonatal Abstinence Syndrome
Utility of Psychosocial Intervention in Improving Outcome for Methadone-exposed Infants and Their Mothers
Opiate drug abuse/addiction is a significant co-morbidity in pregnancy. Opiate maintenance program enhances the outcome of pregnancies for the mother and the infant.
- Trial name
- HOPE (NCT01889121)
- Testing
- Structured psychosocial intervention
- Where
- United States
- Volunteers
- 113 people
- Sponsor
- Dr. Henry Akinbi
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.