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NCT Number: NCT05904145

PRISMA Maternal and Newborn Health Study

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.

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Key information

Conditions

Pregnancy, High Risk

Age range

15 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Kintampo Health Research Centre, Kintampo, Ghana

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

    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.

  2. Composite Severe Maternal Outcomes

    Time frame: Assessed through 12 months postpartum

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

  3. Maternal Anemia

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

    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).

  4. Stillbirth

    Time frame: Assessed at delivery

    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).

  5. Neonatal Mortality

    Time frame: Assessed delivery to 28 days of life

    Death of a live-born baby during the first 28 days of life from any cause.

  6. Preterm Birth

    Time frame: Assessed at delivery

    Delivery prior to 37 completed weeks of gestation of a birth (live or stillbirth). Further classified as extremely preterm (<28 weeks), very preterm (28-32 weeks), and moderate to late preterm (32-37 weeks). For these, gestational age at birth will be determined by the best obstetric estimate: last menstrual period, Ultrasound (method to be determined), and ACOG algorithm.

  7. Low Birth Weight

    Time frame: Assessed at delivery or within 72 hours for home births

    Defined as birth weight <2500 g and very low birth weight <1500 g.

  8. Small-for-Gestational-Age (SGA)

    Time frame: Assessed at delivery

    Combined gestational age information and birthweight will be used to further categorize into: preterm-SGA, preterm-AGA, term-SGA, term-AGA.

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

  5. Gestational Hypertension

    Time frame: : Assessed from 20 weeks gestational age through delivery

  6. Postpartum Hypertension

    Time frame: Assessed at delivery or time of pregnancy to 1 year postpartum

  7. Gestational Diabetes

    Time frame: Assessed between 24 and 28 weeks gestation

  8. Perinatal Depression, as measured using the Edinburgh Postnatal Depression Scale

    Time frame: Assessed at 20 and 32 weeks gestation and 6 weeks postpartum

    The minimum value is 0 and the maximum value is 30. Higher scores indicate that more severe depression may be present.

  9. Maternal Infection and Sepsis

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

  10. Fetal Death

    Time frame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) up until delivery

  11. Cause of Neonatal Death

    Time frame: Assessed at <28 days of life

  12. Cause of Stillbirth

    Time frame: : Assessed from 20 weeks gestational age through time of delivery

  13. Timing of Stillbirth

    Time frame: : Assessed from 20 weeks gestational age through time of delivery

  14. Timing of neonatal mortality

    Time frame: Assessed from delivery to 28 days of life

  15. Infant Mortality

    Time frame: Assessed from delivery to 1 year of life

  16. Hyperbilirubinemia

    Time frame: Assessed at birth, 3 days, and 7 days of age

  17. Neonatal Sepsis

    Time frame: Assessed at delivery through 28 days

  18. Possible Severe Bacterial Infection

    Time frame: Assessed from delivery to 59 days

  19. Postnatal Weight Trajectory

    Time frame: Assessed collected at birth, 3 days, 7 days, and 28 days

  20. Infant Growth

    Time frame: Assessed at birth, 4 weeks, 6 weeks, 6 months, 26 months, and 52 months

Study contacts

Contact information is provided by the study sponsor or research team.

Bethany Freeman, MPH

CONTACT

[email protected]

Emily R Smith, ScD, MPH

CONTACT

[email protected]

12029943589

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • Aga Khan University
  • Centres for Disease Control and Prevention, Kenya.
  • Christian Medical College, Vellore, India
  • Kenya Medical Research Institute
  • Kintampo Health Research Centre, Ghana
  • University of North Carolina, Chapel Hill
  • Vital Pakistan Trust

Registry information

Official study 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

Acronym: PRiSMA-MNH

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jun 15, 2023
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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