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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2022
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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. The study will provide evidence of implementing a package of clinical interventions coupled with quality improvement and monitoring strategy aimed at reducing neonatal mortality in 3 resource-limited health facilities, leveraging on an existing strengthened birth registry to provide neonatal outcomes up to 28 days after delivery. Additionally, using a multifaceted approach through an interdisciplinary team, the investigators will identify the social and cultural barriers that contribute to home-based deliveries. These findings will be helpful to the Ministry of Health in shaping future policies regarding the scale-up of newborn care clinical protocols as part of Government's efforts to reducing neonatal mortality in Zambia.


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
Zambia Chawama 1st Level Hospital, Chipata 1st Level Hospital, and George Clinic Lusaka
Zambia University Teaching Hospital Lusaka

Sponsors (2)

Lead Sponsor Collaborator
University of Alabama at Birmingham Centre for Infectious Disease Research in Zambia

Country where clinical trial is conducted

Zambia, 

Outcome

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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