Clinical trials: Mothers
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
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
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
Respiratory Syncytial Virus Infections
A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women
The purpose of this study is to evaluate the safety, ability of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) to generate an immune response and the degree to which the vaccine can cause side effects, when…
- Trial name
- NCT04138056
- Testing
- RSVPreF3 formulation 3, RSVPreF3 formulation 2, Boostrix-ex-US
- Where
- 8 sites in United States, Belgium and 1 more
- Volunteers
- 509 people, 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
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
Respiratory Syncytial Virus Infections
Study of Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline's (GSK)Respiratory Syncytial Virus (RSV)Maternal Unadjuvanted Vaccine in Healthy Pregnant Women (Aged 18 to 40 Years) and Their Infants
The purpose of this study was to evaluate the safety and immune response to a single intramuscular (IM) dose of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) in healthy pregnant women 18-40 years of age and in…
- Trial name
- NCT04126213
- Testing
- RSV MAT 60 µg, RSV MAT 120 µg
- Where
- 32 sites in United States, Australia and 7 more
- Volunteers
- 534 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
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
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 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
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
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
Diphtheria
A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.
The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in a maternal immunization program in Brazil.
- Trial name
- NCT02757950
- Testing
- Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]
- Where
- Brazil
- Volunteers
- 2,462 people
- 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.
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
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 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 Tract Infection
A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in…
- Trial name
- NCT04424316
- Testing
- RSVpreF
- Where
- 464 sites in United States, Argentina and 16 more
- Volunteers
- 14,727 people, healthy volunteers welcome
- Sponsor
- Pfizer
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