Actively Recruiting

Age: 15Years +
FEMALE
Healthy Volunteers
NCT05904145

PRISMA Maternal and Newborn Health Study

Led by George Washington University · Updated on 2025-06-24

267897

Participants Needed

5

Research Sites

334 weeks

Total Duration

On this page

Sponsors

G

George Washington University

Lead Sponsor

K

Kenya Medical Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

PRISMA Maternal and Newborn Health Study

Who Can Participate

Age: 15Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 less than 20 weeks gestation verified via ultrasound
  • Provides informed consent
Not Eligible

You will not qualify if you...

  • Nonviable pregnancy (e.g., ectopic or molar pregnancy)
  • Plans to relocate outside of the study catchment area during pregnancy and/or postpartum

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Kintampo Health Research Centre

Kintampo, Ghana

Actively Recruiting

2

Christian Medical College (CMC) Vellore

Vellore, India

Actively Recruiting

3

Kenya Medical Research Institute-Center for Global Health Research

Kisumu, Kenya

Actively Recruiting

4

Aga Khan University

Karachi, Pakistan

Actively Recruiting

5

University of North Carolina-Global Projects Zambia

Lusaka, Zambia

Actively Recruiting

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Research Team

E

Emily R Smith, ScD, MPH

CONTACT

J

Jaime Marquis, MPH

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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