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

July 30, 2018 updated by: Clinton Health Access Initiative Inc.

Impact of the Safe Childbirth Checklist on Health Worker Childbirth Practices in Luapula Province of Zambia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

159

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Nchelenge, Zambia
        • Kabuta Rural Health Centre
      • Nchelenge, Zambia
        • Kambwali Rural Health Center
      • Nchelenge, Zambia
        • Kashikishi Rural Health Centre
      • Nchelenge, Zambia
        • St Paul's Mission Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All births will be observed at any time of the day (with two data collectors taking 12-hour shifts). Observations will be conducted for a minimum of three days in all four facilities, or as long as required to observe at least 7 births. It may not be possible for the observer to observe every delivery process at all times, particularly if multiple observations are taking place at one time, so observations will relate to activities at four specific periods (pause points): on admission, when the mother starts pushing, through the delivery to one hour after delivery, and before discharge.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nchelenge Facilities
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.
Behavioral: Introduction of the Safe Childbirth Checklist
  1. Adaptation of the SCC tool to Zambia: In order to produce a tool that is fully relevant to the Zambian context, a team of clinical experts from the MOH adapted the language of the SCC.
  2. Training of trainers on the SCC by international experts: Ariadne Labs has designed a training-of-trainers (TOT) for coach training to support quality improvement initiatives, including the implementation of the WHO SCC. Members of the district mentorship team for Nchelenge District will receive this type of TOT training.
  3. Following the TOT session, the district mentorship team will conduct facility-level training for health workers on using the SCC. Within target facilities, all public sector health workers will be invited to participate in the training.
  4. Mentorship and support to facility-level health workers on using the SCC: The district mentorship team will carry out coaching and support visits to health facilities following the initial SCC training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the average proportion of observed, SCC tasks completed per birth from selected task list
Time Frame: 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
Through study completion, an average of 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinton Health Access Initiative Inc.

Collaborators

Department for International Development, United Kingdom
Ministry of Health, Zambia

Investigators

  • Principal Investigator: Sandra Mudhune, Clinton Health Access Initiative, Nigeria
  • Principal Investigator: Francis Bwalya, Ministry of Health, Zambia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2017

Primary Completion (Actual)

May 4, 2018

Study Completion (Actual)

May 4, 2018

Study Registration Dates

First Submitted

August 22, 2017

First Submitted That Met QC Criteria

August 25, 2017

First Posted (Actual)

August 28, 2017

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3DE SCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

This is yet to be finalized with the Ministry of Health, Zambia.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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