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Completed

NCT Number: NCT03263182

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

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Key information

Conditions

Maternal Death Death Female Urogenital Diseases and Pregnancy Complications Newborn Death Parental Death Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Kabuta Rural Health Centre, Nchelenge, Zambia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Introduction of the Safe Childbirth Checklist

Behavioral
  • 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.
  • 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.
  • 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.
  • 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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Characteristics of health workers participating in facility-level SCC training

    Time frame: Baseline

    Questionnaire to understand Health worker cadre and training

  2. 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

  3. Feedback of health workers in participating facilities on SCC implementation

    Time frame: 6 months

    Questionnaire to understand Health worker cadre and training

  4. 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

Sponsors and collaborators

Lead sponsor

Clinton Health Access Initiative Inc.

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 28, 2017
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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