About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Lives within the study catchment area;
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;
Disqualifiers
Nonviable (e.g. ectopic or molar) pregnancy;
Plans to relocate outside of the study catchment area during pregnancy and/or postpartum.
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Composite Severe Maternal Outcomes
Composite outcome of maternal deaths + near-miss cases + potentially life-threatening complications + critical intervention.
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).
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).
Secondary outcomes
Late Maternal Mortality
Preeclampsia
Preterm Birth Indication
Preterm Premature Rupture of Membranes (PPROM)
Sponsors and contacts
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George Washington University
Lead sponsor
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