PRISMA Maternal and Newborn Health Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pregnancy, High Risk

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Composite outcome of maternal deaths + near-miss cases + potentially life-threatening complications + critical intervention. | Assessed through 12 months postpartum | 
| 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). | Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 6 months postpartum | 
| 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). | Assessed at delivery | 
| Neonatal Mortality | Death of a live-born baby during the first 28 days of life from any cause. | Assessed delivery to 28 days of life | 
| Preterm Birth | 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. | Assessed at delivery | 
| Low Birth Weight | Defined as birth weight <2500 g and very low birth weight <1500 g. | Assessed at delivery or within 72 hours for home births | 
| Small-for-Gestational-Age (SGA) | Combined gestational age information and birthweight will be used to further categorize into: preterm-SGA, preterm-AGA, term-SGA, term-AGA. | Assessed at delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Maternal Mortality |  | Assessed from 42 days postpartum up to one year | 
| Preeclampsia |  | Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum | 
| Preterm Birth Indication |  | Assessed at delivery | 
| Preterm Premature Rupture of Membranes (PPROM) |  | Assessed at <37 weeks of gestation | 
| Gestational Hypertension |  | : Assessed from 20 weeks gestational age through delivery | 
| Postpartum Hypertension |  | Assessed at delivery or time of pregnancy to 1 year postpartum | 
| Gestational Diabetes |  | Assessed between 24 and 28 weeks gestation | 
| Perinatal Depression, as measured using the Edinburgh Postnatal Depression Scale | The minimum value is 0 and the maximum value is 30. Higher scores indicate that more severe depression may be present. | Assessed at 20 and 32 weeks gestation and 6 weeks postpartum | 
| Maternal Infection and Sepsis |  | Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum | 
| Fetal Death |  | Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) up until delivery | 
| Cause of Neonatal Death |  | Assessed at <28 days of life | 
| Cause of Stillbirth |  | : Assessed from 20 weeks gestational age through time of delivery | 
| Timing of Stillbirth |  | : Assessed from 20 weeks gestational age through time of delivery | 
| Timing of neonatal mortality |  | Assessed from delivery to 28 days of life | 
| Infant Mortality |  | Assessed from delivery to 1 year of life | 
| Hyperbilirubinemia |  | Assessed at birth, 3 days, and 7 days of age | 
| Neonatal Sepsis |  | Assessed at delivery through 28 days | 
| Possible Severe Bacterial Infection |  | Assessed from delivery to 59 days | 
| Postnatal Weight Trajectory |  | Assessed collected at birth, 3 days, 7 days, and 28 days | 
| Infant Growth |  | Assessed at birth, 4 weeks, 6 weeks, 6 months, 26 months, and 52 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antenatal Care (ANC), Postnatal Care (PNC), Maternal Newborn Health