PRISMA Maternal and Newborn Health Study (PRiSMA-MNH)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy, High Risk

• Study Type: Observational
• Enrollment (Estimated): 267897

Contacts and Locations

• Study Contact: Name: Emily R Smith, ScD, MPH; Phone Number: 12029943589; Email: emilysmith@gwu.edu
• Study Contact Backup: Name: Bethany Freeman, MPH; Email: bethany.freeman@gwu.edu

Study Locations

• Ghana
  • Kintampo, Ghana
    • Completed
    • Kintampo Health Research Centre
• India
  • Vellore, India
    • Recruiting
    • Christian Medical College (CMC) Vellore
    • Contact: Santosh Benjamin, MD; Email: sbenjamin@cmcvellore.ac.in
    • Contact: Anne George Cherian, MD; Email: annegc@cmcvellore.ac.in
• Kenya
  • Kisumu, Kenya
    • Active, not recruiting
    • Kenya Medical Research Institute-Center for Global Health Research
• Pakistan
  • Karachi, Pakistan
    • Recruiting
    • Aga Khan University
    • Contact: Zahra Hoodbhoy, PhD; Email: zahra.hoodbhoy@aku.edu
• Zambia
  • Lusaka, Zambia
    • Completed
    • University of North Carolina-Global Projects Zambia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The investigators will identify, screen, and enroll pregnant participants through pregnancy surveillance systems, with a goal of identifying pregnancies prior to 20 weeks of pregnancy. Pregnant women will be assessed at <20, 20, 28, 32, and 36 weeks gestation, at labor and delivery, and at 3 days and 1, 4, 6, 26, and 52 weeks postpartum. Infants will similarly be assessed at 3 days and 1, 4, 6, 26, and 52 weeks of age.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Mortality	Death from any cause related to or aggravated by pregnancy or its management (excluding accidental or incidental causes) during pregnancy and childbirth or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy.	Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age), through delivery or termination of pregnancy, and then 42 days postpartum
Composite Severe Maternal Outcomes	Composite outcome of maternal deaths + near-miss cases + potentially life-threatening complications + critical intervention.	Assessed through 12 months postpartum
Maternal Anemia	Low hemoglobin levels throughout pregnancy and labor and delivery, classified as mild (10-10.9 g/dL), moderate (7-9.9 g/dL), or severe (<7 g/dL). Low hemoglobin levels in the postpartum period, classified as mild (11-11.9 g/dL), moderate (8-10.9 g/dL), or severe (<8 g/dL).	Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 6 months postpartum
Stillbirth	Delivery of a fetus showing no signs of life, as indicated by absence of breathing, heartbeat, pulsation of the umbilical cord, or definite movements of voluntary muscles. The primary definition for the study is death prior to delivery of a fetus at >=20 weeks of gestation (or >350 g weight, if gestational age is unavailable). Additionally, we will analyze time-specific definitions: Early stillbirth (20-27 weeks), Late stillbirth (28-36 weeks), Term stillbirth (>=37 weeks), and WHO stillbirth (>=28 weeks).	Assessed at delivery
Neonatal Mortality	Death of a live-born baby during the first 28 days of life from any cause.	Assessed delivery to 28 days of life
Preterm Birth	Delivery prior to 37 completed weeks of gestation of a birth (live or stillbirth). Further classified as extremely preterm (<28 weeks), very preterm (28-32 weeks), and moderate to late preterm (32-37 weeks). For these, gestational age at birth will be determined by the best obstetric estimate: last menstrual period, Ultrasound (method to be determined), and ACOG algorithm.	Assessed at delivery
Low Birth Weight	Defined as birth weight <2500 g and very low birth weight <1500 g.	Assessed at delivery or within 72 hours for home births
Small-for-Gestational-Age (SGA)	Combined gestational age information and birthweight will be used to further categorize into: preterm-SGA, preterm-AGA, term-SGA, term-AGA.	Assessed at delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late Maternal Mortality		Assessed from 42 days postpartum up to one year
Preeclampsia		Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum
Preterm Birth Indication		Assessed at delivery
Preterm Premature Rupture of Membranes (PPROM)		Assessed at <37 weeks of gestation
Gestational Hypertension		: Assessed from 20 weeks gestational age through delivery
Postpartum Hypertension		Assessed at delivery or time of pregnancy to 1 year postpartum
Gestational Diabetes		Assessed between 24 and 28 weeks gestation
Perinatal Depression, as measured using the Edinburgh Postnatal Depression Scale	The minimum value is 0 and the maximum value is 30. Higher scores indicate that more severe depression may be present.	Assessed at 20 and 32 weeks gestation and 6 weeks postpartum
Maternal Infection and Sepsis		Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum
Fetal Death		Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) up until delivery
Cause of Neonatal Death		Assessed at <28 days of life
Cause of Stillbirth		: Assessed from 20 weeks gestational age through time of delivery
Timing of Stillbirth		: Assessed from 20 weeks gestational age through time of delivery
Timing of neonatal mortality		Assessed from delivery to 28 days of life
Infant Mortality		Assessed from delivery to 1 year of life
Hyperbilirubinemia		Assessed at birth, 3 days, and 7 days of age
Neonatal Sepsis		Assessed at delivery through 28 days
Possible Severe Bacterial Infection		Assessed from delivery to 59 days
Postnatal Weight Trajectory		Assessed collected at birth, 3 days, 7 days, and 28 days
Infant Growth		Assessed at birth, 4 weeks, 6 weeks, 6 months, 26 months, and 52 months

Collaborators and Investigators

• Sponsor: George Washington University
• Collaborators: University of North Carolina, Chapel Hill; Aga Khan University; Kenya Medical Research Institute; Christian Medical College, Vellore, India; Kintampo Health Research Centre, Ghana; Vital Pakistan Trust; Centres for Disease Control and Prevention, Kenya.

Publications and helpful links

General Publications

• Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRISMA) Investigators. Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRISMA) Maternal and Newborn Health Study: protocol for a multisite, prospective, open cohort study of pregnancy and postpartum health outcomes in South Asia and sub-Saharan Africa. BMJ Open. 2026 Jan 20;16(1):e104512. doi: 10.1136/bmjopen-2025-104512.
• Smith ER, Hoodbhoy Z, Hotwani A, Jehan F, Khan A, Nisar I, Yazdani N, Benjamin SJ, Cherian AG, Mohan VR, Varghese S, Vijayalekshmi B, Wylie BJ, Chatterjee L, Dang A, Venketeshwar R, Baumann SG, Mores C, Pan Q, Sudfeld CR, Akelo V, Mwebia WK, Otieno K, Ouma G, Owuor H, Were J, Adu-Gyasi D, Agyemang V, Newton S, Tawiah C, Jadaun AS, Mazumder S, Sharma N, Ugwu LG, Benneh-Akwasi Kuma A, Freeman B, Kasaro MP, Mbewe FM, Mwape H, Resop RS, Spelke MB, Asante KP; Redefining Maternal Anemia in Pregnancy and Postpartum (ReMAPP) Study Investigators. Protocol for the Redefining Maternal Anemia in Pregnancy and Postpartum (ReMAPP) study: A multisite, international, population-based cohort study to establish global hemoglobin thresholds for maternal anemia. PLoS One. 2025 Jul 28;20(7):e0321943. doi: 10.1371/journal.pone.0321943. eCollection 2025.
• Naz S, Jaffar A, Yazdani N, Kashif M, Hussain Z, Khan U, Farooq F, Nisar MI, Jehan F, Smith E, Hoodbhoy Z. Cohort profile: the Pregnancy Risk Infant Surveillance and Measurement Alliance (PRISMA) - Pakistan. BMJ Open. 2023 Dec 10;13(12):e078222. doi: 10.1136/bmjopen-2023-078222.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Antenatal Care (ANC); Postnatal Care (PNC); Maternal Newborn Health
• Other Study ID Numbers: PRiSMA-MNH 2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No