Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
267897 participants
OBSERVATIONAL
2022-08-01
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Screening and Treating Asymptomatic Bacteriuria Every Trimester and Preterm Birth
NCT03274960
Perinatal Infections in Pakistan
NCT00070746
Determining the Risk Elevation After Maternity
NCT02305745
A Modernized Approach to Prenatal Care in Low Risk Women
NCT01606774
Risk Prediction Models for Adverse Maternal and Neonatal Outcomes in Preeclampsia
NCT04058405
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* Plans to relocate outside of the study catchment area during pregnancy and/or postpartum.
15 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kenya Medical Research Institute
OTHER
University of North Carolina, Chapel Hill
OTHER
Kintampo Health Research Centre, Ghana
OTHER
Aga Khan University
OTHER
Christian Medical College, Vellore, India
OTHER
Centres for Disease Control and Prevention, Kenya.
OTHER
Vital Pakistan Trust
OTHER
George Washington University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Emily Smith
Princiapl Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kintampo Health Research Centre
Kintampo, , Ghana
Christian Medical College (CMC) Vellore
Vellore, , India
Kenya Medical Research Institute-Center for Global Health Research
Kisumu, , Kenya
Aga Khan University
Karachi, , Pakistan
University of North Carolina-Global Projects Zambia
Lusaka, , Zambia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Smith ER, Hoodbhoy Z, Hotwani A, Jehan F, Khan A, Nisar I, Yazdani N, Benjamin SJ, Cherian AG, Mohan VR, Varghese S, Vijayalekshmi B, Wylie BJ, Chatterjee L, Dang A, Venketeshwar R, Baumann SG, Mores C, Pan Q, Sudfeld CR, Akelo V, Mwebia WK, Otieno K, Ouma G, Owuor H, Were J, Adu-Gyasi D, Agyemang V, Newton S, Tawiah C, Jadaun AS, Mazumder S, Sharma N, Ugwu LG, Benneh-Akwasi Kuma A, Freeman B, Kasaro MP, Mbewe FM, Mwape H, Resop RS, Spelke MB, Asante KP; Redefining Maternal Anemia in Pregnancy and Postpartum (ReMAPP) Study Investigators. Protocol for the Redefining Maternal Anemia in Pregnancy and Postpartum (ReMAPP) study: A multisite, international, population-based cohort study to establish global hemoglobin thresholds for maternal anemia. PLoS One. 2025 Jul 28;20(7):e0321943. doi: 10.1371/journal.pone.0321943. eCollection 2025.
Naz S, Jaffar A, Yazdani N, Kashif M, Hussain Z, Khan U, Farooq F, Nisar MI, Jehan F, Smith E, Hoodbhoy Z. Cohort profile: the Pregnancy Risk Infant Surveillance and Measurement Alliance (PRISMA) - Pakistan. BMJ Open. 2023 Dec 10;13(12):e078222. doi: 10.1136/bmjopen-2023-078222.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRiSMA-MNH 2022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.