PRISMA Maternal and Newborn Health Study

Last updated: August 20, 2024
Sponsor: George Washington University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05904145
PRiSMA-MNH 2022
  • Ages > 15
  • Female
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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 <20 weeks gestation verified via ultrasound;

  • Provides informed consent.

A woman who meets the following exclusion criteria during screening may NOT be enrolled:

  • Nonviable (e.g. ectopic or molar) pregnancy;

  • Plans to relocate outside of the study catchment area during pregnancy and/or postpartum.

Study Design

Total Participants: 267897
Study Start date:
August 01, 2022
Estimated Completion Date:
February 28, 2025

Connect with a study center

  • Kintampo Health Research Centre

    Kintampo,
    Ghana

    Active - Recruiting

  • Christian Medical College (CMC) Vellore

    Vellore,
    India

    Active - Recruiting

  • Kenya Medical Research Institute-Center for Global Health Research

    Kisumu,
    Kenya

    Active - Recruiting

  • Aga Khan University

    Karachi,
    Pakistan

    Active - Recruiting

  • University of North Carolina-Global Projects Zambia

    Lusaka,
    Zambia

    Active - Recruiting

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