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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05904145
Other study ID # PRiSMA-MNH 2022
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date February 28, 2025

Study information

Verified date June 2023
Source George Washington University
Contact Emily R Smith, ScD, MPH
Phone 12029943589
Email emilysmith@gwu.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 267897
Est. completion date February 28, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Ghana Kintampo Health Research Centre Kintampo
India Christian Medical College (CMC) Vellore Vellore
Kenya Kenya Medical Research Institute-Center for Global Health Research Kisumu
Pakistan Aga Khan University Karachi
Zambia University of North Carolina-Global Projects Zambia Lusaka

Sponsors (8)

Lead Sponsor Collaborator
George Washington University 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

Countries where clinical trial is conducted

Ghana,  India,  Kenya,  Pakistan,  Zambia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Composite Severe Maternal Outcomes Composite outcome of maternal deaths + near-miss cases + potentially life-threatening complications + critical intervention. Assessed through 12 months postpartum
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Late Maternal Mortality Assessed from 42 days postpartum up to one year
Secondary Preeclampsia Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum
Secondary Preterm Birth Indication Assessed at delivery
Secondary Preterm Premature Rupture of Membranes (PPROM) Assessed at <37 weeks of gestation
Secondary Gestational Hypertension : Assessed from 20 weeks gestational age through delivery
Secondary Postpartum Hypertension Assessed at delivery or time of pregnancy to 1 year postpartum
Secondary Gestational Diabetes Assessed between 24 and 28 weeks gestation
Secondary 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
Secondary Maternal Infection and Sepsis Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum
Secondary Fetal Death Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) up until delivery
Secondary Cause of Neonatal Death Assessed at <28 days of life
Secondary Cause of Stillbirth : Assessed from 20 weeks gestational age through time of delivery
Secondary Timing of Stillbirth : Assessed from 20 weeks gestational age through time of delivery
Secondary Timing of neonatal mortality Assessed from delivery to 28 days of life
Secondary Infant Mortality Assessed from delivery to 1 year of life
Secondary Hyperbilirubinemia Assessed at birth, 3 days, and 7 days of age
Secondary Neonatal Sepsis Assessed at delivery through 28 days
Secondary Possible Severe Bacterial Infection Assessed from delivery to 59 days
Secondary Postnatal Weight Trajectory Assessed collected at birth, 3 days, 7 days, and 28 days
Secondary Infant Growth Assessed at birth, 4 weeks, 6 weeks, 6 months, 26 months, and 52 months
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