Clinical trial NCT05904145: PRISMA Maternal and Newborn Health Study
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy, High Risk
Keywords: Antenatal Care (ANC)
Postnatal Care (PNC)
Maternal Newborn Health
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: University of North Carolina, Chapel Hill
name: Kintampo Health Research Centre, Ghana
name: Aga Khan University
name: Christian Medical College, Vellore, India
name: Centres for Disease Control and Prevention, Kenya.
name: Vital Pakistan Trust
First posted: 2023-06-15
Enrollment: 267897
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maternal Mortality
timeFrame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age), through delivery or termination of pregnancy, and then 42 days postpartum
measure: Composite Severe Maternal Outcomes
timeFrame: Assessed through 12 months postpartum
measure: Maternal Anemia
timeFrame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 6 months postpartum
measure: Stillbirth
timeFrame: Assessed at delivery
measure: Neonatal Mortality
timeFrame: Assessed delivery to 28 days of life
measure: Preterm Birth
timeFrame: Assessed at delivery
measure: Low Birth Weight
timeFrame: Assessed at delivery or within 72 hours for home births
measure: Small-for-Gestational-Age (SGA)
timeFrame: Assessed at delivery
Secondary outcomes:
measure: Late Maternal Mortality
timeFrame: Assessed from 42 days postpartum up to one year
measure: Preeclampsia
timeFrame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum
measure: Preterm Birth Indication
timeFrame: Assessed at delivery
measure: Preterm Premature Rupture of Membranes (PPROM)
timeFrame: Assessed at <37 weeks of gestation
measure: Gestational Hypertension
timeFrame: : Assessed from 20 weeks gestational age through delivery
measure: Postpartum Hypertension
timeFrame: Assessed at delivery or time of pregnancy to 1 year postpartum
measure: Gestational Diabetes
timeFrame: Assessed between 24 and 28 weeks gestation
measure: Perinatal Depression, as measured using the Edinburgh Postnatal Depression Scale
timeFrame: Assessed at 20 and 32 weeks gestation and 6 weeks postpartum
measure: Maternal Infection and Sepsis
timeFrame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum
measure: Fetal Death
timeFrame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) up until delivery
measure: Cause of Neonatal Death
timeFrame: Assessed at <28 days of life
measure: Cause of Stillbirth
timeFrame: : Assessed from 20 weeks gestational age through time of delivery
measure: Timing of Stillbirth
timeFrame: : Assessed from 20 weeks gestational age through time of delivery
measure: Timing of neonatal mortality
timeFrame: Assessed from delivery to 28 days of life
measure: Infant Mortality
timeFrame: Assessed from delivery to 1 year of life
measure: Hyperbilirubinemia
timeFrame: Assessed at birth, 3 days, and 7 days of age
measure: Neonatal Sepsis
timeFrame: Assessed at delivery through 28 days
measure: Possible Severe Bacterial Infection
timeFrame: Assessed from delivery to 59 days
measure: Postnatal Weight Trajectory
timeFrame: Assessed collected at birth, 3 days, 7 days, and 28 days
measure: Infant Growth
timeFrame: Assessed at birth, 4 weeks, 6 weeks, 6 months, 26 months, and 52 months
Other outcomes:
Locations:
city: Kintampo
country: Ghana
facility: Kintampo Health Research Centre
city: Vellore
country: India
facility: Christian Medical College (CMC) Vellore
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute-Center for Global Health Research
city: Karachi
country: Pakistan
facility: Aga Khan University
city: Lusaka
country: Zambia
facility: University of North Carolina-Global Projects Zambia
Study officials:
References: