NCT05904145 PRISMA Maternal and Newborn Health Study
| NCT ID | NCT05904145 |
| Status | Recruiting |
| Phase | — |
| Sponsor | George Washington University |
| Condition | Pregnancy, High Risk |
| Study Type | OBSERVATIONAL |
| Enrollment | 267,897 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 267,897 participants in total. It began in 2022-08-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05904145 clinical trial?
This trial is open to female participants only, aged 15 Years or older, studying Pregnancy, High Risk. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05904145 currently recruiting?
Yes, NCT05904145 is actively recruiting participants. Contact the research team at emilysmith@gwu.edu for enrollment information.
Where is the NCT05904145 trial being conducted?
This trial is being conducted at Kintampo, Ghana, Vellore, India, Kisumu, Kenya, Karachi, Pakistan and 1 additional location.
Who is sponsoring the NCT05904145 clinical trial?
NCT05904145 is sponsored by George Washington University. The trial plans to enroll 267,897 participants.