← Back to all trials
Recruiting
NCT05904145
PRISMA Maternal and Newborn Health Study
Conditions: Pregnancy, High Risk
Sex: Female
Ages: 15 Years – N/A
Healthy volunteers: Yes
Enrollment: 267897
Sponsor: George Washington University
Location: Kintampo Health Research Centre Kintampo
Summary
Access to quality antenatal care (ANC) and postnatal care (PNC), including maternal, newborn, and infant services, is integral to reducing adverse pregnancy-related health outcomes and promoting positive birth experiences. The World Health Organization (WHO) recommends a total of eight ANC visits for pregnant women. However, the ANC coverage rate remains considerably lower among more vulnerable populations, and the quality of care that women receive is inconsistent, often poor, and frequently fails to detect risks in a timely fashion or adequately prepare women for the birth process. While rates of facility-based delivery are on the rise worldwide, disparities persist and the quality of care across facilities remains uneven. Even less information is available on PNC, where services beyond routine immunizations may not be widely available, especially in resource-poor regions.
Additionally, limited evidence exists on innovative service delivery approaches and how to effectively scale tested maternal and newborn health (MNH) interventions. This coupled with the fragmented datasets from smaller studies limit our ability to advocate for policy change.
The Pregnancy Risk Stratification Innovation and Measurement Alliance (PRiSMA) is implementing a harmonized open cohort study that seeks to evaluate pregnancy risk factors and their associations with adverse pregnancy outcomes, including stillbirth, neonatal mortality and morbidity, and maternal mortality and severe morbidity. The goals are to develop a harmonized data set to improve understanding of pregnancy risk factors, vulnerabilities, and morbidity and mortality and to estimate the burden of these risk factors and outcomes in LMICs. Ultimately, these data will inform development of innovative strategies to optimize pregnancy outcomes for mothers and their newborns.
Eligibility Criteria
A woman who meets the following inclusion criteria during screening may be enrolled:
* Lives within the study catchment area;
* Meets minimum age requirement in study site country:
* Ghana: 15 years of age;
* Kenya: 18 years of age or those who meet the criteria of emancipated minors;
* Pakistan: 15 years of age or those who meet the criteria of emancipated minors;
* Zambia: 15 years of age;
* India: 18 years of age
* Intrauterine pregnancy \
Source: ClinicalTrials.gov (NCT05904145). StuddyBuddy aggregates publicly available trial information.