PRISMA Maternal and Newborn Health Study

NCT05904145 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 267897

Last updated 2025-06-24

No results posted yet for this study

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.

Conditions

  • Pregnancy, High Risk

Sponsors & Collaborators

  • Kenya Medical Research Institute

    collaborator OTHER
  • University of North Carolina, Chapel Hill

    collaborator OTHER
  • Kintampo Health Research Centre, Ghana

    collaborator OTHER
  • Aga Khan University

    collaborator OTHER
  • Christian Medical College, Vellore, India

    collaborator OTHER
  • Centres for Disease Control and Prevention, Kenya.

    collaborator OTHER
  • Vital Pakistan Trust

    collaborator OTHER
  • George Washington University

    lead OTHER

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Ghana
  • India
  • Kenya
  • Pakistan
  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05904145 on ClinicalTrials.gov