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

Maternal Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263182
• Other study ID #: 3DE SCC
• Status: Completed
• Start date: September 4, 2017
• Est. completion date: May 4, 2018

Study information

• Verified date: July 2018
• Source: Clinton Health Access Initiative Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: May 4, 2018
• Est. primary completion date: May 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Death
• Maternal Death
• Newborn Death

Intervention

Behavioral:
• Introduction of the Safe Childbirth Checklist
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.

Locations

Country	Name	City	State
Zambia	Kabuta Rural Health Centre	Nchelenge
Zambia	Kambwali Rural Health Center	Nchelenge
Zambia	Kashikishi Rural Health Centre	Nchelenge
Zambia	St Paul's Mission Hospital	Nchelenge

Sponsors (3)

Lead Sponsor	Collaborator
Clinton Health Access Initiative Inc.	Department for International Development, United Kingdom, Ministry of Health, Zambia

Country where clinical trial is conducted

Zambia, 

References & Publications (21)

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.

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

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.

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.

Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. Review. — View Citation

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

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

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

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. Review. — View Citation

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. — View Citation

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. Epub 2005 Jan 8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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.

* Note: There are 21 references in all — Click here to view all references

Outcome

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

External Links

•   Maternal mortality factsheet. Updated November 2016