An observational study in Pregnancy, High Risk, sponsored by George Washington University. Recruiting at 5 sites in 5 countries. Open to female participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by George Washington University · Observational
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.
George Washington University is the lead sponsor of 192 studies on the registry; 34 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
A woman who meets the following inclusion criteria during screening may be enrolled:
Meets minimum age requirement in study site country:
A woman who meets the following exclusion criteria during screening may NOT be enrolled:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Composite Severe Maternal Outcomes
Composite outcome of maternal deaths + near-miss cases + potentially life-threatening complications + critical intervention.
Time frame: 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).
Time frame: 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).
Time frame: Assessed at delivery
Neonatal Mortality
Death of a live-born baby during the first 28 days of life from any cause.
Time frame: 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.
Time frame: Assessed at delivery
Low Birth Weight
Defined as birth weight \<2500 g and very low birth weight \<1500 g.
Time frame: 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.
Time frame: Assessed at delivery
Late Maternal Mortality
Time frame: Assessed from 42 days postpartum up to one year
Preeclampsia
Time frame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum
Preterm Birth Indication
Time frame: Assessed at delivery
Preterm Premature Rupture of Membranes (PPROM)
Time frame: Assessed at <37 weeks of gestation
Gestational Hypertension
Time frame: : Assessed from 20 weeks gestational age through delivery
Postpartum Hypertension
Time frame: Assessed at delivery or time of pregnancy to 1 year postpartum
Gestational Diabetes
Time frame: 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.
Time frame: Assessed at 20 and 32 weeks gestation and 6 weeks postpartum
Maternal Infection and Sepsis
Time frame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) through 42 days postpartum
Fetal Death
Time frame: Assessed from time of pregnancy identification (on average, 10-20 weeks gestational age) up until delivery
Cause of Neonatal Death
Time frame: Assessed at <28 days of life
Cause of Stillbirth
Time frame: : Assessed from 20 weeks gestational age through time of delivery
Timing of Stillbirth
Time frame: : Assessed from 20 weeks gestational age through time of delivery
Timing of neonatal mortality
Time frame: Assessed from delivery to 28 days of life
Infant Mortality
Time frame: Assessed from delivery to 1 year of life
Hyperbilirubinemia
Time frame: Assessed at birth, 3 days, and 7 days of age
Neonatal Sepsis
Time frame: Assessed at delivery through 28 days
Possible Severe Bacterial Infection
Time frame: Assessed from delivery to 59 days
Postnatal Weight Trajectory
Time frame: Assessed collected at birth, 3 days, 7 days, and 28 days
Infant Growth
Time frame: Assessed at birth, 4 weeks, 6 weeks, 6 months, 26 months, and 52 months
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Started Aug 2022 (actual). Primary completion is estimated for Dec 2028, 76 months after the start.
How these figures are worked out, and which studies are left out of them.
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