Clinical trials: Maternal
Down Syndrome, Fetal Aneuploidy
Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies
Whole blood samples will be collected from high-risk pregnant women to validate the clinical performance of the SEQureDx Trisomy 21 Test.
- Trial name
- NCT01555346
- Where
- 29 sites in United States, Canada
- Volunteers
- 3,062 people
- Sponsor
- Sequenom, Inc.
Respiratory Syncytial Virus Infections
A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control
The purpose of this follow-up study was to describe the safety in subsequent pregnancies in participants who were previously administered the RSVPreF3 maternal vaccine or control during any prior RSV MAT study.
- Trial name
- NCT05705440
- Testing
- RSVPreF3 vaccine, Control
- Where
- 138 sites in United States, Argentina and 21 more
- Volunteers
- 3,855 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
A Study of Safety, Reactogenicity and Immune Response of the Repeat Vaccination Against RSV When Given to Female Participants of 18-49 Years of Age During Their Subsequent Uncomplicated Pregnancy
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a single intramuscular dose of the investigational respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine during subsequent…
- Trial name
- NCT05229068
- Testing
- RSV MAT
- Where
- 2 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240526
- Testing
- Engerix™ -B, Hepatitis B immunoglobulin (HBIg)
- Where
- Thailand
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Breast Feeding
Human Milk Composition in Indian Mothers
Nutritional profile of mother's milk is influenced by various factors including environmental, dietary and nutritional status of the mother.
- Trial name
- NCT03061929
- Where
- 8 sites in India
- Volunteers
- 248 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Pregnancy Related, Mothers
COVID-19 Vaccine Confidence Among Pregnant Women and Mothers
The purpose of this study is to assess the level of vaccine confidence and influencers among pregnant women and mothers of school-aged children during the COVID-19 pandemic.
- Trial name
- VCCOVID (NCT04694664)
- Testing
- This is an online survey with no intervention.
- Where
- United States
- Volunteers
- 18,000 people, healthy volunteers welcome
- Sponsor
- Pregistry
Pregnancy Related
Cell- Based Noninvasive Prenatal Testing (NIPT): Single Cell Prenatal Diagnosis (SCPD)
The purpose of the overall study is to develop improved methods for recovery of fetal cells from the mother's blood in order to develop a clinically useful form of cell-based, diagnostic, noninvasive prenatal testing (NIPT).
- Trial name
- NIPT & SCPD (NCT05076734)
- Testing
- Redraw for analysis of blood samples from healthy pregnant women
- Where
- United States
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- Luna Genetics
Respiratory Syncytial Virus Infections
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the GlaxoSmithKline (GSK) Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine (GSK3003891A) in Healthy Pregnant Women and Infants Born to Vaccinated Mothers
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK RSV vaccine in pregnant women aged 18 to 40 years and infants born to the vaccinated women
- Trial name
- NCT03191383
- Testing
- RSV vaccine (GSK3003891A) formulation 1, RSV vaccine (GSK3003891A) formulation 2, RSV vaccine (GSK3003891A) formulation 3
- Where
- 12 sites in United States, Finland and 1 more
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pregnancy
Maternal Fetal Device Performance Singleton
Maternal Fetal Monitoring devices assist the health care professional in acquiring, monitoring, and storing fetal and maternal physiologic data which supports the decision making for pregnant women and the overall fetal health…
- Trial name
- NCT06726343
- Testing
- Fetal Monitoring Device, Investigational Fetal Monitoring Device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- GE Healthcare
Microdeletion Syndromes, Trisomy 21
Development of Non-invasive Prenatal Test for Microdeletion and Other Genetic Syndromes Based on Cell Free DNA
The purpose of this study is to collect blood from families with a child who has been diagnosed with a chromosomal disorder including microdeletions in order to further develop a non-invasive prenatal screening test based on…
- Conditions
- Microdeletion Syndromes, Trisomy 21, Trisomy 18, Trisomy 13
- Trial name
- Microdel Triad (NCT02109770)
- Where
- 2 sites in United States
- Volunteers
- 216 people
- Sponsor
- Natera, Inc.
Chagas Disease
An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health
This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied.
- Trial name
- NCT05477953
- Testing
- Nifurtimox (BAYA2502)
- Where
- 12 sites in United States, Argentina and 10 more
- Volunteers
- 50 people
- Sponsor
- Bayer
Gestational Mother, Streptococcus Agalactiae Infection
Effect of a New Probiotic Strain in the Reduction of Group B Streptococcus Colonization in Pregnant Women
An interventional, randomized, multicenter, double-blind, placebo-controlled, parallel-group study will be conducted to evaluate the effectiveness of the strain Lactobacillus salivarius V4II-90 in the reduction of Group B…
- Trial name
- PROBIGEST (NCT03669094)
- Testing
- Lactobacillus salivarius V4II-90
- Where
- Spain
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- ProbiSearch SL
Maternal Health Care
Evaluating the Impact of a Symptom Checker on Healthcare-seeking Decisions: a Mixed-Methods Study
The goal of this study is to evaluate the integration of a symptom checker (SC) into the MomConnect (MC) platform to support maternal healthcare in South Africa.
- Trial name
- SAFEMOM (NCT06790069)
- Where
- South Africa
- Volunteers
- 968 people
- Sponsor
- Ada Health GmbH
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.
Postnatal Care
Mom Multi Postnatal Supplementation Trial
The goal of this clinical trial is to learn if a vitamin and mineral supplement designed specifically for women after childbirth can improve their nutrition and health in women who are pregnant or have recently given birth…
- Trial name
- NCT07303595
- Testing
- Perelel Mom Multi
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Perelel Inc.
Breastfeeding, Exclusive
MILC: A Comprehensive Mobile Application That Addresses the Breastfeeding Challenges of Low-income Hispanic Mothers
The innovative platform MILC is designed to provide an integrated and comprehensive professional and social support network with personalized breastfeeding (BF) education to target exclusive breastfeeding (EBF) and any BF…
- Trial name
- MILC (NCT06520696)
- Testing
- MILC application, Usual care
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Benten Technologies, Inc.
Diphtheria, Acellular Pertussis
Impact of Boostrix™ Maternal Vaccination on Morbidity and Mortality of Pertussis Disease in Infants ≤6 Weeks of Age, in Bogota, Colombia.
This study is being conducted to assess impact of maternal immunisation against pertussis in infants ≤12 months of age before and after introduction of pertussis maternal immunisation in Bogota, Colombia from January…
- Conditions
- Diphtheria, Acellular Pertussis, Tetanus, Aspergillosis, Allergic Bronchopulmonary
- Trial name
- NCT02569879
- Testing
- Pertussis maternal immunization
- Where
- Colombia
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements.
- Trial name
- PRIMULA Lac (NCT06594068)
- Testing
- Anifrolumab
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- AstraZeneca
Down Syndrome (Trisomy 21), Edwards Syndrome (Trisomy 18)
Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
Validate that circulating cell free fetal nucleic acid can be used to identify a direct marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than surrogate markers.
- Conditions
- Down Syndrome (Trisomy 21), Edwards Syndrome (Trisomy 18), Patau Syndrome (Trisomy 13), Turner Syndrome
- Trial name
- NCT00770458
- Where
- 7 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Sequenom, Inc.
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