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

NCT ID: NCT03263182

Last Updated: 2018-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

159 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-04

Study Completion Date

2018-05-04

Brief Summary

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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

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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.

Conditions

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Maternal Death Newborn Death

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Introduction of the Safe Childbirth Checklist

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Department for International Development, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Ministry of Health, Zambia

OTHER_GOV

Sponsor Role collaborator

Clinton Health Access Initiative Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandra Mudhune

Role: PRINCIPAL_INVESTIGATOR

Clinton Health Access Initiative, Nigeria

Francis Bwalya

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, Zambia

Locations

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Kabuta Rural Health Centre

Nchelenge, , Zambia

Site Status

Kambwali Rural Health Center

Nchelenge, , Zambia

Site Status

Kashikishi Rural Health Centre

Nchelenge, , Zambia

Site Status

St Paul's Mission Hospital

Nchelenge, , Zambia

Site Status

Countries

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Zambia

References

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Albolinoa S, Daglianaa G, et al. Safety and quality of maternal and neonatal pathway: A pilot study on the childbirth checklist in 9 Italian hospitals. Procedia Manufacturing. 2015; (3):242-249.

Reference Type BACKGROUND

Ariadne Labs. Implementing Checklists for Quality Improvement: The Namibian Experience using the WHO Safe Childbirth Checklist.

Reference Type BACKGROUND

Central Statistical Office (CSO), Ministry of Health (MOH), Tropical Diseases Research Centre (TDRC), University of Zambia, and Macro International Inc. (2014). Zambia Demographic and Health Survey 2014. Calverton, Maryland, USA: CSO and Macro International Inc.

Reference Type BACKGROUND

Davoodi R, Soltanifar A, et al. Efficacy of Evidence Based Care on Care Quality of Mother and Infant in 3 Teaching Hospitals: A Protocol. Patient Safety and Quality Improvement Journal. 2013 Dec 14; 2(2):97-100.

Reference Type BACKGROUND

Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. doi: 10.1093/ije/28.2.319.

Reference Type BACKGROUND
PMID: 10342698 (View on PubMed)

Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009 Jan 29;360(5):491-9. doi: 10.1056/NEJMsa0810119. Epub 2009 Jan 14.

Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 26271331 (View on PubMed)

Kumar S, Yadav V, Balasubramaniam S, Jain Y, Joshi CS, Saran K, Sood B. Effectiveness of the WHO SCC on improving adherence to essential practices during childbirth, in resource constrained settings. BMC Pregnancy Childbirth. 2016 Nov 8;16(1):345. doi: 10.1186/s12884-016-1139-x.

Reference Type BACKGROUND
PMID: 27825321 (View on PubMed)

Kumari S, Panicker R, et al. Evaluation of the Safe Childbirth Checklist Program in Rajasthan, India: The How and What of the Evaluation Efforts. Journal of Public Health in Developing Countries. 2016 Aug 11;2(2);212-222.

Reference Type BACKGROUND

McCambridge J, Witton J, Elbourne DR. Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects. J Clin Epidemiol. 2014 Mar;67(3):267-77. doi: 10.1016/j.jclinepi.2013.08.015. Epub 2013 Nov 22.

Reference Type BACKGROUND
PMID: 24275499 (View on PubMed)

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Reference Type BACKGROUND
PMID: 23962135 (View on PubMed)

Ministry of Health [Zambia]. Health Sector Payroll Data. January 2014.

Reference Type BACKGROUND

Ministry of Health [Zambia]. Emergency Obstetric and Newborn Care (EmONC) Training Process Evaluation Report. February 2017.

Reference Type BACKGROUND

Ministry of Health [Zambia]. Zambia National Emergency Obstetric and Newborn Care (EmONC) Needs Assessment 2014-5. January 2017.

Reference Type BACKGROUND

Patabendige M, Senanayake H. Implementation of the WHO safe childbirth checklist program at a tertiary care setting in Sri Lanka: a developing country experience. BMC Pregnancy Childbirth. 2015 Feb 4;15:12. doi: 10.1186/s12884-015-0436-0.

Reference Type BACKGROUND
PMID: 25648543 (View on PubMed)

Paxton A, Maine D, Freedman L, Fry D, Lobis S. The evidence for emergency obstetric care. Int J Gynaecol Obstet. 2005 Feb;88(2):181-93. doi: 10.1016/j.ijgo.2004.11.026. Epub 2005 Jan 8.

Reference Type BACKGROUND
PMID: 15694106 (View on PubMed)

Spector JM, Agrawal P, Kodkany B, Lipsitz S, Lashoher A, Dziekan G, Bahl R, Merialdi M, Mathai M, Lemer C, Gawande A. Improving quality of care for maternal and newborn health: prospective pilot study of the WHO safe childbirth checklist program. PLoS One. 2012;7(5):e35151. doi: 10.1371/journal.pone.0035151. Epub 2012 May 16.

Reference Type BACKGROUND
PMID: 22615733 (View on PubMed)

Spector JM, Lashoher A, Agrawal P, Lemer C, Dziekan G, Bahl R, Mathai M, Merialdi M, Berry W, Gawande AA. Designing the WHO Safe Childbirth Checklist program to improve quality of care at childbirth. Int J Gynaecol Obstet. 2013 Aug;122(2):164-8. doi: 10.1016/j.ijgo.2013.03.022. Epub 2013 Jun 3.

Reference Type BACKGROUND
PMID: 23742897 (View on PubMed)

Wang P, Connor AL, Guo E, Nambao M, Chanda-Kapata P, Lambo N, Phiri C. Measuring the impact of non-monetary incentives on facility delivery in rural Zambia: a clustered randomised controlled trial. Trop Med Int Health. 2016 Apr;21(4):515-24. doi: 10.1111/tmi.12678.

Reference Type BACKGROUND
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WHO. Making pregnancy safer: the critical role of the skilled attendant. A joint statement by WHO, ICM, and FIGO. Geneva: Department of Reproductive Health and Research, World Health Organization. 2004.

Reference Type BACKGROUND

WHO. Making pregnancy safer the critical role of the skilled attendant: a joint statement by WHO, ICM and FIGO. Geneva: World health organization (WHO). Department of Reproductive Health and Research (RHR). 2004.

Reference Type BACKGROUND

Mudhune S, Phiri SC, Prescott MR, McCarthy EA, Banda A, Haimbe P, Mwansa FD, Mwiche A, Silumesii A, Micheck K, Shakwelele H, Prust ML. Improving the quality of childbirth services in Zambia through introduction of the Safe Childbirth Checklist and systems-focused mentorship. PLoS One. 2020 Dec 30;15(12):e0244310. doi: 10.1371/journal.pone.0244310. eCollection 2020.

Reference Type DERIVED
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Mudhune S, Phiri SC, Prescott MR, McCarthy EA, Banda A, Haimbe P, Mwansa FD, Mwiche A, Bwalya F, Kabamba M, Shakwelele H, Prust ML. Impact of the Safe Childbirth Checklist on health worker childbirth practices in Luapula province of Zambia: a pre-post study. BMC Public Health. 2018 Jul 18;18(1):892. doi: 10.1186/s12889-018-5813-y.

Reference Type DERIVED
PMID: 30021547 (View on PubMed)

Related Links

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http://www.who.int/mediacentre/factsheets/fs348/en/.

Maternal mortality factsheet. Updated November 2016

Other Identifiers

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3DE SCC

Identifier Type: -

Identifier Source: org_study_id

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