Clinical trials: Mother
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
Lactating Mother
Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk
The primary objectives of this clinical trial performed with Vyleesi (Bremelanotide Injection) are: to evaluate if Bremelanotide (BMT) is secreted in breast milk of lactating women treated with a single dose of BMT 1.75 mg SC.
- Trial name
- NCT06867835
- Testing
- Vyleesi (Bremelanotide Injection)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cosette Pharmaceuticals, Inc.
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
Maternal-Fetal Exchange
Maternal Uterine Artery Doppler Study
The purpose of this study is to detect if adding resistance to maternal blood flow from the arm will help increase the blood flow through the uterine arteries to the placenta and the baby.
- Trial name
- NCT01698957
- Testing
- Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.
- Where
- 2 sites in United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Obstetrix Medical Group
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
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
Respiratory Syncytial Virus Infections
RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women.
The purpose of this study is to evaluate the safety and immunogenicity of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy third-trimester pregnant women and to assess the impact of maternal immunization on infant…
- Trial name
- NCT02247726
- Testing
- RSV F vaccine (0.5mL injection)
- Where
- 7 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Novavax
Breast Pumping
Clinical Investigation to Assess the Performance of the Eureka Electric Breast Pump in Mothers Breastfeeding Their Healthy Term Infant
Babies are the best in class in order to get human milk out of a lactating breast. With this in mind, Philips has developed the a new electric breast pump, attempting to mimic the babies sucking behavior.
- Trial name
- EUREKA (NCT03960190)
- Testing
- Using Eureka Breast Pump with Expression Kit
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Philips Consumer Lifestyle
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
Respiratory Syncytial Virus, Respiratory Tract Diseases
Impact and Effectiveness of ABRYSVO® Vaccination During Pregnancy
This study will be conducted in collaboration with a research network of independent hospital sites to evaluate the vaccine effectiveness (VE) and impact of ABRYSVO vaccination during pregnancy in a real-world population over…
- Trial name
- BERNI (NCT06647654)
- Testing
- ABRYSVO
- Where
- Argentina
- Volunteers
- 1 people
- Sponsor
- Pfizer
Obstetric Labour, Premature
Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
The primary objective of this study is to assess the safety and outcomes of infants and children who were exposed to retosiban or comparator in utero in the Phase III spontaneous preterm labor (SPTL) treatment studies, to provide…
- Trial name
- ARIOS (NCT02292784)
- Testing
- Retosiban, Atosiban
- Where
- 26 sites in United States, Belgium and 9 more
- Volunteers
- 98 people
- 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
Infertility, Female
Preimplantation Genetic Testing in Women of Advanced Maternal Age
The GETSET trial is a prospective randomized trial designed to evaluate the clinical outcomes of incorporating preimplantation genetic testing for aneuploidies (PGT-A) in elective single embryo transfer in women between 35 and 40…
- Trial name
- GETSET (NCT04167748)
- Testing
- Preimplantation genetic testing for aneuploidy (PGT-A)
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Genomic Prediction Inc.
Respiratory Syncytial Virus Infections
A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization
The purpose of this study is to determine the efficacy of maternal immunization during the third trimester of pregnancy with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI), as defined…
- Trial name
- NCT02624947
- Testing
- RSV F vaccine with adjuvant, Formulation buffer
- Where
- 88 sites in United States, Argentina and 9 more
- Volunteers
- 4,636 people, healthy volunteers welcome
- Sponsor
- Novavax
Breast Pumping
Initiate Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card
The study hypothesizes that mothers who are both breastfeeding and pumping in the first days report improved comfort levels with the new Symphony program card INITIATE 2.0 compared to the standard of care.
- Trial name
- Initiate (NCT04619212)
- Testing
- breast pumping as per SoC but on new software for the pump
- Where
- Netherlands
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Medela AG
Acquired Immunodeficiency Syndrome
Open Label Study of NVP+CBV Treatment in Women Who Have Received sdNVP for the pMTCT of HIV
To determine the response to treatment with NVP, ZDV and 3TC in HIV positive women, who previously received NVP for the prevention of mother to child transmission.
- Trial name
- NCT00144157
- Testing
- Nevirapine, Zidovudine, 3TC
- Where
- 3 sites in South Africa
- Volunteers
- 53 people
- Sponsor
- Boehringer Ingelheim
Healthy Infant and Mother Pairs
Ex Vivo Exploratory Analysis in Healthy Full-term Infants
Exploratory analyses of the immune response in a ex vivo culture system Characterization of the composition of maternal milk and infant urine
- Trial name
- NCT01573884
- Where
- 2 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Maternal Glycemia
Nutritional Intervention During Gestation and Offspring Health
The purpose of this study is to investigate the potential effects of a modified carbohydrate nutritional product for obese pregnant women to reduce maternal glycemia.
- Trial name
- NCT02285764
- Testing
- Nutritional Supplement, Standard of Care
- Where
- 3 sites in Germany, Spain
- Volunteers
- 331 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Hypoparathyroidism
A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
The purpose of this registry study is to collect both prospective and retrospective data in women exposed to palopegteriparatide during pregnancy to assess risk of pregnancy and maternal complications, and adverse effects on the…
- Trial name
- NCT07345494
- Testing
- Palopegteriparatide
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Ascendis Pharma A/S
Gestational Mother, Streptococcus Agalactiae Infection
Colonization with Group B Streptococcus During Pregnancy
An observational study to estimate the probability of pregnant women, who were GBS-negative in the first trimester of pregnancy become GBS-positive at the end of pregnancy. It is an observational.
- Trial name
- PROBIGEST (NCT03671486)
- Where
- Spain
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- ProbiSearch SL