Clinical trials: Maternal
Infantile Colic, Infant Sleeping Habits
Role of ProTectis on Infant Colic and Its Effect on Infant Crying Time and Maternal Mental Health
This study will work on hypothetical assumption that compared to the arm supplemented with placebo (control) group; the L reuteri (intervention) group will lower daily crying/fussing time per 24 hours at one month post…
- Conditions
- Infantile Colic, Infant Sleeping Habits, Maternal Mental Health.
- Trial name
- PRIC-SMM (NCT02094092)
- Testing
- ProTectis drops (five drops per day) for 21 days
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Ferozsons Laboratories Ltd.
Hyperphenylalaninemia (HPA) Due to Phenylketonuria (PKU) or Tetrahydrobiopterin (BH4) Deficiency
Observational Study on the Long Term Safety of Kuvan® Treatment in Patients With Hyperphenylalaninemia (HPA) Due to Phenylketonuria (PKU) or BH4 Deficiency
Kuvan® is a synthetic copy of a body's own substance called tetrahydrobiopterin (BH4). BH4 is required by the body to use an amino acid called phenylalanine in order to build another substance called tyrosine.
- Trial name
- KAMPER (NCT01016392)
- Where
- 69 sites in Austria, France and 7 more
- Volunteers
- 627 people
- Sponsor
- BioMarin Pharmaceutical
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 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
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
Aneuploidy, NIPT
A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood
A diagnostic peripheral maternal blood test taken and the free foetal DNA is analysed and the presence of trisomies using a novel method.
- Trial name
- IONA (NCT01472523)
- Where
- United Kingdom
- Volunteers
- 1,632 people
- Sponsor
- Premaitha Health
Maternal Health
Joyuus - A Web-based Tool for Postpartum Care Self-care for Underserved Women
The goal of this RCT is to evaluate the effectiveness of Joyuus on improving maternal functioning with postpartum moms. The main questions it aims to answer are: The primary hypothesis is that participants of the Joyuus program…
- Trial name
- NCT05876559
- Testing
- Joyuus Self-care Mobile App, Standard Care
- Where
- United States
- Volunteers
- 137 people
- Sponsor
- Joyuus, LLC
Attachment
Effects of Mother-infant Skin-to-skin Contact in Postpartum Women
When a newborn is delivered in good physiological condition, immediate skin-to-skin contact with the mother is required. Skin-to-skin contact has a wide range of benefits for both mother and baby.
- Trial name
- NCT06781307
- Testing
- skin to skin
- Where
- Taiwan
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Jen-Ai Hospital Institutional Review Board
Breastmilk Collection
Impact of Breast Milk on the Infectivity and Transmission of Different Viruses "BREASTMILKVIR"
Exclusive breastfeeding during the first six months of life and continued breastfeeding for at least 24 months constitute the optimal feeding method for infants and young children.
- Trial name
- BREASTMILKVIR (NCT06738563)
- Testing
- Collection breast milk
- Where
- France
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Systemic Lupus Erythematosus
Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy…
- Trial name
- PRIMULA_Preg (NCT06659029)
- Testing
- Anifrolumab
- Where
- United States
- Volunteers
- 442 people
- Sponsor
- AstraZeneca
Maternal Outcomes, Infant Outcomes
Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy
The primary objectives of this study are: In infants of women exposed to SPIKEVAX during pregnancy, to assess: If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of major congenital…
- Conditions
- Maternal Outcomes, Infant Outcomes, Pregnancy
- Trial name
- NCT06369272
- Where
- United States
- Volunteers
- 1,192 people, healthy volunteers welcome
- Sponsor
- ModernaTX, 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
Respiratory Syncytial Virus Infections
A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women
The purpose of this study is to evaluate different dose levels of the investigational RSV maternal vaccine (GSK3888550A) based on safety/reactogenicity and immune response data.
- Trial name
- NCT03674177
- Testing
- GSK3888550A RSV Maternal vaccine formulation 1, GSK3888550A RSV Maternal vaccine formulation 2, GSK3888550A RSV Maternal vaccine formulation 3
- Where
- 11 sites in United States, Finland and 1 more
- Volunteers
- 502 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Down Syndrome, Fetal Aneuploidy
Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy
The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.
- Trial name
- NCT01429389
- Where
- 14 sites in United States, Canada
- Volunteers
- 2,000 people
- Sponsor
- Sequenom, Inc.
Skin Aging, Reproductive Aging
Multidimensional Correlation Study on Skin Aging in Menopausal Women
Primary Objective: This study primarily aims to compare skin aging characteristics between women at different stages of reproductive aging in both sun-exposed and non-exposed areas, based on skin indicators collected during a…
- Conditions
- Skin Aging, Reproductive Aging, Menopause, Genetic Factors
- Trial name
- NCT07390305
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- ChinaNorm
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
Down Syndrome, Edwards Syndrome
Non-Invasive Screening for Fetal Aneuploidy
The purpose of this study is to detect whole chromosome abnormalities in maternal blood.
- Trial name
- NCT02317965
- Testing
- Maternal Blood Draw
- Where
- 10 sites in United States
- Volunteers
- 340 people
- Sponsor
- Progenity, Inc.
Friedreich Ataxia
A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies
In this study, researchers will learn more about the safety of BIIB141, also known as omaveloxolone or SKYCLARYS. This is a drug available for doctors to prescribe for people with Friedrich's Ataxia, also known as FA.
- Trial name
- NCT06628687
- Testing
- Omaveloxolone
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Biogen
Trisomy 13, Trisomy 18
High Risk Multiple Gestation Study
The objectives of the clinical study are to demonstrate the accuracy of our proprietary algorithm method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample.
- Conditions
- Trisomy 13, Trisomy 18, Trisomy 21, Sex Chromosome Abnormalities
- Trial name
- NCT02278874
- Where
- 4 sites in United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Natera, Inc.
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