Preterm Birth Clinical Trial
— PREEMIOfficial title:
Preterm Resources, Education, and Effective Management for Infants
NCT number | NCT03923023 |
Other study ID # | 14-F0023 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2014 |
Est. completion date | June 30, 2018 |
Verified date | May 2022 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The purpose of this Quality Improvement initiative is to reduce severe morbidity and mortality among premature infants through proven and cost-effective clinical management during the antenatal, intrapartum, and postpartum periods. In order to reduce neonatal mortality and morbidity due to preterm birth complications, health facilities must be able to identify and manage women in preterm labor, accurately administer medications, and provide high-quality postnatal care.
Status | Completed |
Enrollment | 11195 |
Est. completion date | June 30, 2018 |
Est. primary completion date | October 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 10 Years and older |
Eligibility | Inclusion Criteria: - Pregnant women who seek Antenatal care services and plan to deliver in the selected health facilities - Women who reside within the larger catchment area of the selected 3 health facilities Exclusion Criteria: - Women who reside outside the larger catchment area of the health facilities - Women who have not sought antenatal care services in the 3 health facilities and have come to only deliver there |
Country | Name | City | State |
---|---|---|---|
Zambia | Chawama 1st Level Hospital, Chipata 1st Level Hospital, and George Clinic | Lusaka | |
Zambia | University Teaching Hospital | Lusaka |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | Centre for Infectious Disease Research in Zambia |
Zambia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 10% relative risk reduction in 28-day neonatal mortality rate in preterm infants | Rate of 28-day neonatal mortality at the end of the study compared to that at baseline | Baseline to 36 months | |
Secondary | 20% relative risk reduction in all-cause 7-day neonatal mortality in preterm infants | Rate of 7-day neonatal mortality at the end of the study compared to that at baseline | Baseline to 36 months | |
Secondary | Factors that contribute to home and facility deliveries within the PREEMI facility catchment areas through the use of pre-determined questionnaire. | Number of study participants who delivered at home and at a health facility | Baseline to 36 months |
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