PRISMA Maternal and Newborn Health Study

NCT05904145 | Recruiting DMC

• 1 other identifier: PRiSMA-MNH 2022
• Study Type: observational
• Target: 267,897
• Locations: 5 countries
• Sites: 5

Brief 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

Keywords

Antenatal Care (ANC); Postnatal Care (PNC); Maternal Newborn Health

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (20)

• 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

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (5)

Kintampo Health Research Centre

Kintampo, Ghana

RECRUITING

Christian Medical College (CMC) Vellore

Vellore, India

RECRUITING

Kenya Medical Research Institute-Center for Global Health Research

Kisumu, Kenya

RECRUITING

Aga Khan University

Karachi, Pakistan

RECRUITING

University of North Carolina-Global Projects Zambia

Lusaka, Zambia

RECRUITING

Related Publications (3)

• 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.

  PMID: 41558748 DERIVED

• 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.

  PMID: 40720446 DERIVED

• 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.

  PMID: 38072494 DERIVED

Central Study Contacts

Emily R Smith, ScD, MPH

CONTACT

12029943589; emilysmith@gwu.edu

Jaime Marquis, MPH

CONTACT

jmarquis@gwu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Princiapl Investigator

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: June 15, 2023
• Study Start: August 1, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

KE (1); ZA (1); PA (1); IN (1); GH (1)