PRISMA Maternal and Newborn Health Study
- Conditions
- Pregnancy, High Risk
- Registration Number
- NCT05904145
- Lead Sponsor
- George Washington University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
A woman who meets the following inclusion criteria during screening may be enrolled:<br><br> - Lives within the study catchment area;<br><br> - Meets minimum age requirement in study site country:<br><br> - Ghana: 15 years of age;<br><br> - Kenya: 18 years of age or those who meet the criteria of emancipated minors;<br><br> - Pakistan: 15 years of age or those who meet the criteria of emancipated minors;<br><br> - Zambia: 15 years of age;<br><br> - India: 18 years of age<br><br> - Intrauterine pregnancy <20 weeks gestation verified via ultrasound;<br><br> - Provides informed consent.<br><br>A woman who meets the following exclusion criteria during screening may NOT be enrolled:<br><br> - Nonviable (e.g. ectopic or molar) pregnancy;<br><br> - Plans to relocate outside of the study catchment area during pregnancy and/or<br> postpartum.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maternal Mortality;Composite Severe Maternal Outcomes;Maternal Anemia;Stillbirth;Neonatal Mortality;Preterm Birth;Low Birth Weight;Small-for-Gestational-Age (SGA)
- Secondary Outcome Measures
Name Time Method Perinatal Depression, as measured using the Edinburgh Postnatal Depression Scale;Maternal Infection and Sepsis;Fetal Death;Cause of Neonatal Death;Cause of Stillbirth;Timing of Stillbirth;Timing of neonatal mortality;Infant Mortality;Hyperbilirubinemia;Neonatal Sepsis;Possible Severe Bacterial Infection;Postnatal Weight Trajectory;Infant Growth;Late Maternal Mortality;Preeclampsia;Preterm Birth Indication;Preterm Premature Rupture of Membranes (PPROM);Gestational Hypertension;Postpartum Hypertension;Gestational Diabetes