Clinical trial NCT03263182: Impact of the Safe Childbirth Checklist in Luapula Province of Zambia Province of Zambia
Official title: Impact of the Safe Childbirth Checklist on Health Worker Childbirth Practices in Luapula Province of Zambia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maternal Death
Newborn Death
Keywords: childbirth
delivery
Lead sponsor: Clinton Health Access Initiative Inc.
Sponsor class: OTHER
Collaborators: name: Department for International Development, United Kingdom
name: Ministry of Health, Zambia
First posted: 2017-08-28
Enrollment: 159
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Change in the average proportion of observed, SCC tasks completed per birth from selected task list
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Characteristics of health workers participating in facility-level SCC training
timeFrame: Baseline
measure: Feedback of health workers participating in facility-level SCC training
timeFrame: Baseline
measure: Feedback of health workers in participating facilities on SCC implementation
timeFrame: 6 months
measure: Feedback of health workers in participating facilities on SCC implementation
timeFrame: 6 months
Other outcomes:
Locations:
city: Nchelenge
country: Zambia
facility: Kabuta Rural Health Centre
city: Nchelenge
country: Zambia
facility: Kambwali Rural Health Center
city: Nchelenge
country: Zambia
facility: Kashikishi Rural Health Centre
city: Nchelenge
country: Zambia
facility: St Paul's Mission Hospital
Study officials:
affiliation: Clinton Health Access Initiative, Nigeria
name: Sandra Mudhune
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Health, Zambia
name: Francis Bwalya
role: PRINCIPAL_INVESTIGATOR
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