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

NCT03263182 | Completed

• 1 other identifier: 3DE SCC
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 4

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.

Conditions

Maternal Death; Newborn Death

Keywords

childbirth; delivery

Outcome Measures

Primary Outcomes (1)

• Change in the average proportion of observed, SCC tasks completed per birth from selected task list

  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 Outcomes (4)

• Characteristics of health workers participating in facility-level SCC training

  Baseline

• Feedback of health workers participating in facility-level SCC training

  Baseline

• Feedback of health workers in participating facilities on SCC implementation

  6 months

• Feedback of health workers in participating facilities on SCC implementation

  6 months

Study Arms (1)

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

Interventions

Introduction of the Safe Childbirth Checklist 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.

Nchelenge Facilities

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Clinton Health Access Initiative Inc.: lead
• Department for International Development, United Kingdom: collaborator
• Ministry of Health, Zambia: collaborator

Study Sites (4)

Kabuta Rural Health Centre

Nchelenge, 0, Zambia

Location

Kambwali Rural Health Center

Nchelenge, 0, Zambia

Location

Kashikishi Rural Health Centre

Nchelenge, 0, Zambia

Location

St Paul's Mission Hospital

Nchelenge, 0, Zambia

Location

Related Publications (23)

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  BACKGROUND

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

  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.

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  PMID: 10342698 BACKGROUND

• 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.

  PMID: 19144931 BACKGROUND

• Hirschhorn LR, Semrau K, Kodkany B, Churchill R, Kapoor A, Spector J, Ringer S, Firestone R, Kumar V, Gawande A. Learning before leaping: integration of an adaptive study design process prior to initiation of BetterBirth, a large-scale randomized controlled trial in Uttar Pradesh, India. Implement Sci. 2015 Aug 14;10:117. doi: 10.1186/s13012-015-0309-y.

  PMID: 26271331 BACKGROUND

• 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.

  PMID: 27825321 BACKGROUND

• 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.

  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.

  PMID: 24275499 BACKGROUND

• Moyer CA, Mustafa A. Drivers and deterrents of facility delivery in sub-Saharan Africa: a systematic review. Reprod Health. 2013 Aug 20;10:40. doi: 10.1186/1742-4755-10-40.

  PMID: 23962135 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  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.

  PMID: 25648543 BACKGROUND

• 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.

  PMID: 15694106 BACKGROUND

• 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.

  PMID: 22615733 BACKGROUND

• 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.

  PMID: 23742897 BACKGROUND

• 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.

  PMID: 26848937 BACKGROUND

• 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.

  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.

  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.

  PMID: 33378372 DERIVED

• 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.

  PMID: 30021547 DERIVED

Related Links

• Maternal mortality factsheet. Updated November 2016

MeSH Terms

Conditions

Maternal Death; Perinatal Death

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sandra Mudhune

  Clinton Health Access Initiative, Nigeria

  PRINCIPAL INVESTIGATOR

• Francis Bwalya

  Ministry of Health, Zambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 28, 2017
• Study Start: September 4, 2017
• Primary Completion: May 4, 2018
• Study Completion: May 4, 2018
• Last Updated: July 31, 2018

Record last verified: 2018-07

Locations

ZA (4)