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RECRUITING
NCT05904145

PRISMA Maternal and Newborn Health Study

Sponsor: George Washington University

View on ClinicalTrials.gov

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.

Official title: Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRiSMA) Maternal and Newborn Health (MNH) Study: A Multi-center, Prospective Cohort Study of Maternal, Newborn, and Infant Health

Key Details

Gender

FEMALE

Age Range

15 Years - Any

Study Type

OBSERVATIONAL

Enrollment

267897

Start Date

2022-08-01

Completion Date

2028-12-31

Last Updated

2025-06-24

Healthy Volunteers

Yes

Locations (5)

Kintampo Health Research Centre

Kintampo, Ghana

Christian Medical College (CMC) Vellore

Vellore, India

Kenya Medical Research Institute-Center for Global Health Research

Kisumu, Kenya

Aga Khan University

Karachi, Pakistan

University of North Carolina-Global Projects Zambia

Lusaka, Zambia