Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05904145
Status:
RECRUITING
Last Update Posted:
2023-06-15
First Post:
2022-10-14
Brief Title:
PRISMA Maternal and Newborn Health Study
Sponsor:
George Washington University
Organization:
George Washington University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRiSMA-MNH
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None