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CompletedNCT03263182Updated Jul 31, 2018

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

An observational study in Maternal Death and Newborn Death, sponsored by Clinton Health Access Initiative Inc.. Completed at 4 sites in Zambia. Per ClinicalTrials.gov, last updated 2018-07-31.

Sponsored by Clinton Health Access Initiative Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
159
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Maternal Death
  • Newborn Death

Keywords

  • childbirth
  • delivery
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

Exclusion Criteria:

-

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
159 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • BehavioralIntroduction 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.

05

What researchers measure

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

    Time frame: Through study completion, an average of 6 months

Secondary outcomes

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

    Questionnaire to understand Health worker cadre and training

    Time frame: Baseline

  2. 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

    Time frame: Baseline

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

    Questionnaire to understand Health worker cadre and training

    Time frame: 6 months

  4. 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

    Time frame: 6 months

06

Study locations

4 sites
  • Kabuta Rural Health Centre
    Nchelenge, 0, Zambia
  • Kambwali Rural Health Center
    Nchelenge, 0, Zambia
  • Kashikishi Rural Health Centre
    Nchelenge, 0, Zambia
  • St Paul's Mission Hospital
    Nchelenge, 0, Zambia
07

References and documents

Publications

  • 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. doi: 10.1093/ije/28.2.319. PubMed 10342698 ↗
  • 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. PubMed 19144931 ↗
  • 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. PubMed 26271331 ↗
  • 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. PubMed 27825321 ↗
  • 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. PubMed 24275499 ↗
  • 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. PubMed 23962135 ↗
  • Ministry of Health [Zambia]. Health Sector Payroll Data. January 2014.
  • Ministry of Health [Zambia]. Emergency Obstetric and Newborn Care (EmONC) Training Process Evaluation Report. February 2017.
  • Ministry of Health [Zambia]. Zambia National Emergency Obstetric and Newborn Care (EmONC) Needs Assessment 2014-5. January 2017.
  • 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. PubMed 25648543 ↗
  • 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. PubMed 15694106 ↗
  • 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. PubMed 22615733 ↗
  • 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. PubMed 23742897 ↗
  • 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. PubMed 26848937 ↗
  • 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.
  • 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.
  • 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. PubMed 33378372 ↗
  • 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. PubMed 30021547 ↗

Individual participant data

Plan to share: Undecided — This is yet to be finalized with the Ministry of Health, Zambia.

08

Registry details

Key details

Study ID
NCT03263182
Lead sponsor
Clinton Health Access Initiative Inc.
Collaborators
Department for International Development, United Kingdom, Ministry of Health, Zambia
Responsible party
Sponsor
First posted
Aug 28, 2017
Start date
Sep 4, 2017
Primary completion
May 4, 2018
Completion
May 4, 2018
Last update
Jul 31, 2018

Study contacts

Sandra Mudhune
principal investigator · Clinton Health Access Initiative, Nigeria
Francis Bwalya
principal investigator · Ministry of Health, Zambia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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