Impact of the Safe Childbirth Checklist in Luapula Province of Zambia Province of Zambia

Completed

• Conditions: Maternal Death; Newborn Death
• Interventions: Behavioral: Introduction of the Safe Childbirth Checklist

• Registration Number: NCT03263182
• Lead Sponsor: Clinton Health Access Initiative Inc.

Brief Summary

This study would like to determine if the introduction of the Safe Childbirth Checklist and associated mentorship can improve the adherence of skilled birth attendants (SBAs) to the essential practices of childbirth delivery.

Detailed Description

This study will use a pre-post study design to measure health worker adherence to the essential practices for delivery care outlined in the Safe Childbirth Checklist (SCC). The intervention, including the introduction of the SCC and mentorship visits to support uptake, will be tested in four purposively selected health facilities in Nchelenge District, Luapula Province of Zambia. Since the essential delivery care practices outlined in the SCC are evidence-based practices broadly accepted to support positive clinical outcomes for mothers and infants, this evaluation will focus on adherence to the checklist rather than on patient outcomes. Data will be collected through observations of skilled birth attendants assisting with childbirth delivery before the start of the intervention and again at 3 months and 6 months post-intervention. A health worker questionnaire will be administered at the time that the SCC is introduced and six months later to gather their perspectives on incorporating the SCC into clinical practice in Zambia.

Study Timeline

• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-28
• Study Start: 2017-09-04
• Primary Completion: 2018-05-04
• Study Completion: 2018-05-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• For facility observations, all consecutive deliveries will be observed. If a pregnant woman or health worker declines to participate in the consent process, no observations will be recorded.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nchelenge Facilities	Introduction of the Safe Childbirth Checklist	Purposively selected health facilities based on criteria including: high demand for services, perceived need for support for quality improvement, and presence of a SBA to mentor.

Primary Outcome Measures

Name	Time	Method
Change in the average proportion of observed, SCC tasks completed per birth from selected task list	Through study completion, an average of 6 months	Numerator: Count of SCC tasks observed and completed for each delivery, according to the specifications for data collection outlined in the data collection procedures Denominator: Count of potential SCC items observed

Secondary Outcome Measures

Name	Time	Method
Feedback of health workers in participating facilities on SCC implementation	6 months	Proportion of health workers agreeing with on ease of using the SCC and challenges faced in implementation
Characteristics of health workers participating in facility-level SCC training	Baseline	Questionnaire to understand Health worker cadre and training
Feedback of health workers participating in facility-level SCC training	Baseline	Proportion of health workers agreeing with statements on the clarity of the training and their confidence in using the SCC after the training

Trial Locations

Locations (4)

Kabuta Rural Health Centre; 🇿🇲 Nchelenge, Zambia

Kambwali Rural Health Center; 🇿🇲 Nchelenge, Zambia

St Paul's Mission Hospital; 🇿🇲 Nchelenge, Zambia

Kashikishi Rural Health Centre; 🇿🇲 Nchelenge, Zambia