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Recruiting NCT05904145

PRISMA Maternal and Newborn Health Study

— Observational Pregnancy, High Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pregnancy, High Risk. Basic parameters: from 15 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ghana, India, Kenya, Pakistan, Zambia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Maternal Mortality [Time frame: 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 [Time frame: Assessed through 12 months postpartum]
  • Maternal Anemia [Time frame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 6 months postpartum]
  • Stillbirth [Time frame: Assessed at delivery]
  • Neonatal Mortality [Time frame: Assessed delivery to 28 days of life]
  • Preterm Birth [Time frame: Assessed at delivery]
  • Low Birth Weight [Time frame: Assessed at delivery or within 72 hours for home births]
  • Small-for-Gestational-Age (SGA) [Time frame: Assessed at delivery]
Secondary outcome measures (12)
  • Late Maternal Mortality [Time frame: Assessed from 42 days postpartum up to one year]
  • Preeclampsia [Time frame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum]
  • Preterm Birth Indication [Time frame: Assessed at delivery]
  • Preterm Premature Rupture of Membranes (PPROM) [Time frame: Assessed at <37 weeks of gestation]
  • Gestational Hypertension [Time frame: : Assessed from 20 weeks gestational age through delivery]
  • Postpartum Hypertension [Time frame: Assessed at delivery or time of pregnancy to 1 year postpartum]
  • Gestational Diabetes [Time frame: Assessed between 24 and 28 weeks gestation]
  • Perinatal Depression, as measured using the Edinburgh Postnatal Depression Scale [Time frame: Assessed at 20 and 32 weeks gestation and 6 weeks postpartum]
  • Maternal Infection and Sepsis [Time frame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum]
  • Fetal Death [Time frame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) up until delivery]
  • Cause of Neonatal Death [Time frame: Assessed at <28 days of life]
  • Cause of Stillbirth [Time frame: : Assessed from 20 weeks gestational age through time of delivery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Ghana · 1 center
  • Kintampo Health Research Centre — Kintampo
India · 1 center
  • Christian Medical College (CMC) Vellore — Vellore
Kenya · 1 center
  • Kenya Medical Research Institute-Center for Global Health Research — Kisumu
Pakistan · 1 center
  • Aga Khan University — Karachi
Zambia · 1 center
  • University of North Carolina-Global Projects Zambia — Lusaka

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 PMID 41558748
  • 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, Kas PMID 40720446
  • 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

Identifiers

NCT: NCT05904145 · PRiSMA-MNH 2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗