Antenatal, Intrapartum and Postnatal Care: A Prospective, Longitudinal Study of Maternal and Newborn Health of the Pregnancy Risk Stratification Innovation and Measurement Alliance (PRISMA study).

March 19,2022 | Ongoing Project | Reading time: 6 min

Investigators

PI: Dr. Kwaku Poku Asante.
Co-PIs: Prof. Sam Newton, Mrs. Charlotte Tawiah Agyemang Project/Study Coordinators: Mrs. Irene Apewe Adjei, Mrs. Ellen Boamah-Kaali, Mr. Lawrence Gyabaah Febir, Mr. Kenneth Wiru
Data Managers: Mr. Seeba Amenga-Etego,Mr. Eliezer Ofori Odei-Lartey.
Statistician: Ms. Stephaney Gyaase
Biomedical Scientist/Laboratory Technologist: Dr. Dennis Adu-Gyasi, Mrs. Veronica Agyemang and Mr. Dennis Konadu Gyasi.

Background
Quality antenatal and postnatal care services are important and gaining recognition with increasing antenatal care coverages in low- and middle-income countries. However, the ANC coverage rate is much lower among more vulnerable populations (e.g. lower quintile, rural regions), and the quality of care that women receive is inconsistent, often poor, and frequently fails to detect risks in a timely fashion or to prepare women for the birth process. While most women access skilled antenatal care at least once during pregnancy, there is poor continuity of care and only about 60% of women receive the recommended four ANC visits by WHO.

From a surveillance perspective, there is a lack of robust population-level burden data to inform global and local estimation of key risk factors, vulnerabilities and morbidity and mortality outcomes among pregnant women and mother-infant pairs during the duration of antenatal and postnatal care. Robust data on pregnancy risks, including medical history, clinical symptoms and diagnostics, social determinants, as well as antenatal and intrapartum care are critical to developing strategies to effectively manage pregnancy risk and improve outcomes, within resource-constrained environments.

Goal

The goal of this study is to develop a harmonized data set to improve our understanding of pregnancy risk factors, vulnerabilities, and morbidity and mortality and to estimate the burden of these risk factors and outcomes in Low and Middle-Income Countries. Ultimately, these data will inform the development of innovative strategies to optimize pregnancy outcomes for mothers and their newborns.

Method

The Pregnancy Risk Stratification: Innovation & Measurement Alliance (PRISMA), is a longitudinal study of maternal and newborn health, with emphasis on the pregnancy risk factors and their associations with adverse pregnancy outcomes, including stillbirth, neonatal mortality and morbidity, and maternal mortality and severe morbidity. This is a multi-country population-based study involving five countries in Sub-Saharan Africa and South east Asia: Ghana, Kenya, Zambia, Pakistan and India.

A total of 16,000 pregnant women are to be enrolled from all sites on the study. The target enrollment for Ghana is 3,500. Pregnant women whose gestational ages are less than 20 weeks will be enrolled into the study and scheduled visits will be made throughout their antenatal (ANC), intrapartum (IPC) and postpartum (PNC) periods up to 1 year after delivery.

A harmonization phase is proposed where the protocol will be implemented uniformly across sites, with special effort to ensure that the primary health outcomes and related risk factors are assessed using standardized methods. For the harmonization an additional 20,250 pregnant women (cohort 2) will be recruited across sites in 3 years with 3,000 from KHRC. We 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.

Progress
Recruitment into the cohort 1 was halted in July 2022, however, participants already enrolled into the study are being followed-up. As at 14th December 2022, a total of 3,163 potential participants were screen and 2,285 participants were consented and enrolled into the PRISMA study. One-thousand nine-hundred and ninety-five (1,995) of the enrolled particicpants have delivered. Out of the recorded deliveries, 1995 were live births, 24 fresh still birth and 19 macerated still birth

The study protocol was amended to include the harmonization activities (cohort 2). There was a site initiation visit by Guosa Life Sciences (GLS) on 7th December, 2022 to assess the readiness of the team for the re-launch of the PRISMA study.

Ethical approvals from the Kintampo Health Research Centre’s Institutional Ethics Committee and the Ghana Health Service Ethics Review Board were obtained in December 2022. Enrollment into cohort 2 (PRISMA) begun on 29th December, 2022.

Collaborators:
George Washington University: Dr. Emily Smith, Jamie Marquis and Megan Talej.
Columbia University: Dr. Blair Wylie

Funders:
Bill and Melinda Gates Foundation (BMGF)