Clinical trials: Mother
Respiratory Syncytial Virus
A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants
The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine. It will be studied in infants born to mothers living with HIV.
- Trial name
- MORISOT (NCT06325657)
- Testing
- RSVpreF vaccine, Placebp
- Where
- 14 sites in South Africa
- Volunteers
- 681 people
- Sponsor
- Pfizer
Preterm Delivery, Inadequate Milk Production
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
Induction and support of lactation in women with preterm delivery and inadequate milk production.
- Trial name
- MERMAID (NCT02545127)
- Testing
- Merotocin
- Where
- 10 sites in United States
- Volunteers
- 4 people
- Sponsor
- Ferring Pharmaceuticals
Pregnancy
Maternal Fetal Device Performance Twins
Maternal Fetal Monitoring devices assist the health care professional in acquiring, monitoring, and storing fetal and maternal physiologic data which support clinical decision making for pregnant women and assesses the overall…
- Trial name
- NCT06835647
- Testing
- Investigational Fetal Monitor, Ultrasound Imaging Device
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- GE Healthcare
Pregnancy
Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability
The specific goal of the proposed research is to develop a reliable, non-invasive fetal and maternal heart rate and contraction monitor that is unaffected by obesity and requires less nursing intervention than the tocodynamometer…
- Trial name
- NCT01400880
- Testing
- Electrode-based Sensor
- Where
- United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Convergent Engineering, Inc.
Respiratory Syncytial Virus Infections
A Phase III, Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers
The purpose of this study was to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly (IM) to pregnant women aged 18-49 years, in good general maternal health, in…
- Trial name
- GRACE (NCT04605159)
- Testing
- RSV MAT
- Where
- 159 sites in United States, Argentina and 22 more
- Volunteers
- 11,194 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Infections, Cytomegalovirus, Cytomegalovirus Infections
Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus
This study is designed to evaluate maternal virological and immunological parameters to determine their ability to predict congenital cytomegalovirus (CMV) infection.
- Trial name
- NCT01251744
- Testing
- Blood sample, Cord blood sample, Saliva swab
- Where
- 9 sites in Belgium
- Volunteers
- 160 people
- 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
Fetal Monitoring
A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepartum Fetal Monitoring
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate and maternal heart rate on pregnant women with a singleton pregnancy, starting from 32 weeks of gestation.
- Trial name
- NST (NCT04915131)
- Testing
- Bloomlife MFM-Pro
- Where
- 2 sites in United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Bloom Technologies
GBS Disease, Streptococcus Agalactiae
Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific antibodies in infants, placental transfer from the…
- Trial name
- NCT02046148
- Testing
- GBS trivalent vaccine
- Where
- 6 sites in United States
- Volunteers
- 75 people
- Sponsor
- GlaxoSmithKline
Postpartum, Women
Monitoring and Outreach for Maternal Safety Postpartum
Two arm study, intervention and control, to explore the impact of an online training program to help community health workers (CHWs) conduct effective outreach to support postpartum mothers, particularly those at higher risk for…
- Conditions
- Postpartum, Women, Community Health Workers, Knowledge
- Trial name
- MOMSPostpartum (NCT06899737)
- Testing
- MOMS Postpartum Course
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- KDH Research & Communication
Whooping Cough
Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States
The purpose of this study is to estimate the effectiveness of maternal immunization with Boostrix at preventing pertussis in infants in the United States.
- Trial name
- NCT03973905
- Testing
- Not applicable / dataset analysis
- Where
- Belgium
- Volunteers
- 290 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acellular Pertussis, Tetanus
Immunogenicity and Safety Study of Infanrix Hexa in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women who participated in study 116945 [DTPA…
- Conditions
- Acellular Pertussis, Tetanus, Poliomyelitis, Diphtheria
- Trial name
- NCT02422264
- Testing
- Infanrix hexa, Prevnar13
- Where
- 30 sites in Australia, Canada and 4 more
- Volunteers
- 601 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
A Study on the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers
The purpose of this study was to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of the respiratory syncytial virus (RSV) maternal vaccine compared to placebo, when administered in the…
- Trial name
- NCT04980391
- Testing
- RSV MAT
- Where
- 35 sites in United States, Brazil and 7 more
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration…
- Conditions
- Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis, Crohn's Disease
- Trial name
- CRADLE (NCT02154425)
- Testing
- Breast milk sampling, Certolizumab Pegol
- Where
- 6 sites in United States, Netherlands and 1 more
- Volunteers
- 17 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Respiratory Syncytial Virus Infections
A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.
The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA).
- Trial name
- NCT05045144
- Testing
- RSVPreF3(120 μg), Flu Quadrivalent influenza vaccine (15 μg HA)
- Where
- 36 sites in United States, Canada and 3 more
- Volunteers
- 1,586 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA
A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta
The primary purpose is to assess whether there is transfer of Certolizumab Pegol (CZP) from pregnant women receiving treatment with Cimzia® across the placenta to infants by evaluating the concentration of CZP in the plasma of…
- Conditions
- Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis, Crohn's Disease
- Trial name
- CRIB (NCT02019602)
- Testing
- Blood sampling from mother, Blood sampling from infant, Blood sampling from umbilical cord
- Where
- 8 sites in United States, France and 2 more
- Volunteers
- 37 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Hepatitis B
Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)
This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™.
- Trial name
- NCT00240539
- Testing
- Blood sampling
- Where
- Thailand
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240500
- Testing
- Engerix™-B
- Where
- Thailand
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
SARS-CoV-2 Infection, COVID-19
To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
Results will be submitted, however please note that data are not yet available for all serology outcome measures. This will be a Phase 2/3, randomized, placebo-controlled, observer-blind study evaluating the safety, tolerability…
- Conditions
- SARS-CoV-2 Infection, COVID-19, Maternal Immunization
- Trial name
- NCT04754594
- Testing
- BNT162b2
- Where
- 90 sites in United States, Brazil and 3 more
- Volunteers
- 726 people, healthy volunteers welcome
- Sponsor
- BioNTech SE