PRISMA Maternal and Newborn Health Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age15+
SponsorGeorge Washington University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

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
2

Composite Severe Maternal Outcomes

Composite outcome of maternal deaths + near-miss cases + potentially life-threatening complications + critical intervention.

Time frame
Assessed through 12 months postpartum
3

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).

Time frame
Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 6 months postpartum
4

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).

Time frame
Assessed at delivery

Secondary outcomes

1

Late Maternal Mortality

Time frame
Assessed from 42 days postpartum up to one year
2

Preeclampsia

Time frame
Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum
3

Preterm Birth Indication

Time frame
Assessed at delivery
4

Preterm Premature Rupture of Membranes (PPROM)

Time frame
Assessed at <37 weeks of gestation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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