PRISMA Maternal and Newborn Health Study

Официальное название

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

Обзор

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.

Первичные конечные точки

• Maternal Mortality [Срок оценки: 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 [Срок оценки: Assessed through 12 months postpartum]
• Maternal Anemia [Срок оценки: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 6 months postpartum]
• Stillbirth [Срок оценки: Assessed at delivery]
• Neonatal Mortality [Срок оценки: Assessed delivery to 28 days of life]
• Preterm Birth [Срок оценки: Assessed at delivery]
• Low Birth Weight [Срок оценки: Assessed at delivery or within 72 hours for home births]
• Small-for-Gestational-Age (SGA) [Срок оценки: Assessed at delivery]

Вторичные конечные точки (12)

• Late Maternal Mortality [Срок оценки: Assessed from 42 days postpartum up to one year]
• Preeclampsia [Срок оценки: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum]
• Preterm Birth Indication [Срок оценки: Assessed at delivery]
• Preterm Premature Rupture of Membranes (PPROM) [Срок оценки: Assessed at <37 weeks of gestation]
• Gestational Hypertension [Срок оценки: : Assessed from 20 weeks gestational age through delivery]
• Postpartum Hypertension [Срок оценки: Assessed at delivery or time of pregnancy to 1 year postpartum]
• Gestational Diabetes [Срок оценки: Assessed between 24 and 28 weeks gestation]
• Perinatal Depression, as measured using the Edinburgh Postnatal Depression Scale [Срок оценки: Assessed at 20 and 32 weeks gestation and 6 weeks postpartum]
• Maternal Infection and Sepsis [Срок оценки: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum]
• Fetal Death [Срок оценки: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) up until delivery]
• Cause of Neonatal Death [Срок оценки: Assessed at <28 days of life]
• Cause of Stillbirth [Срок оценки: : Assessed from 20 weeks gestational age through time of delivery]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Ghana · 1 центр

• Kintampo Health Research Centre — Kintampo

Индия · 1 центр

• Christian Medical College (CMC) Vellore — Vellore

Kenya · 1 центр

• Kenya Medical Research Institute-Center for Global Health Research — Kisumu

Пакистан · 1 центр

• Aga Khan University — Karachi

Zambia · 1 центр

• University of North Carolina-Global Projects Zambia — Lusaka

Публикации

• 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

Идентификаторы

NCT: NCT05904145 · PRiSMA-MNH 2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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