PRISMA Maternal and Newborn Health Study

Pregnancy, High Risk Clinical Trial

— PRiSMA-MNH  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05904145
• Other study ID #: PRiSMA-MNH 2022
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Pregnancy, High Risk

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