Maternal DeathNCT03263182
Impact of the Safe Childbirth Checklist in Luapula Province of Zambia Province of Zambia
An observational study of Maternal Death and Newborn Death, run by Clinton Health Access Initiative Inc. at 4 sites in Zambia.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Maternal Death, Newborn Death
- What is being tested?
- Introduction of the Safe Childbirth Checklist
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 159 participants
- Where
- 4 sitesZambia
- Study dates
- 4 Sep 2017to 4 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
4 sites in 1 country.
Zambia4 sites
Kabuta Rural Health Centre
Nchelenge, 0
Kambwali Rural Health Center
Nchelenge, 0
Kashikishi Rural Health Centre
Nchelenge, 0
St Paul's Mission Hospital
Nchelenge, 0
About this study
Official title: Impact of the Safe Childbirth Checklist on Health Worker Childbirth Practices in Luapula Province of Zambia
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.
- Conditions
- Maternal Death, Newborn Death
- Being tested
- Introduction of the Safe Childbirth Checklist
- Keywords
- childbirth, delivery
- Medical subject headings
- Maternal Death, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Introduction of the Safe Childbirth ChecklistBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Introduction of the Safe Childbirth Checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 6 months
Secondary outcomes (4)
Characteristics of health workers participating in facility-level SCC training
Questionnaire to understand Health worker cadre and training
Measured: Baseline
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
Measured: Baseline
Feedback of health workers in participating facilities on SCC implementation
Questionnaire to understand Health worker cadre and training
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start4 Sep 2017
- Primary completion4 May 2018
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Maternal DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinton Health Access Initiative Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Department for International Development, United Kingdom, Ministry of Health, Zambia
- Responsible party
- Sponsor
- Investigators
- Sandra Mudhune, Principal investigator, Clinton Health Access Initiative, NigeriaFrancis Bwalya, Principal investigator, Ministry of Health, Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263182
- Sponsor's protocol ID
- 3DE SCC
- Status last verified
- Jul 2018
- First submitted
- 22 Aug 2017
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is yet to be finalized with the Ministry of Health, Zambia.
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 10342698Haynes 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 19144931Hirschhorn 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 26271331Kumar 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 27825321Kumari 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 24275499Moyer 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 23962135Ministry 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Safe Childbirth Checklist on Health Worker Childbirth Practices in Luapula Province of Zambia
- ClinicalTrials.gov ID
- NCT03263182
- Acronym / sponsor ID
- 3DE SCC
- Conditions
- Maternal Death, Newborn Death
- Keywords
- childbirth, delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Clinton Health Access Initiative Inc.University, hospital or other
- Collaborators
- Department for International Development, United Kingdom, Ministry of Health, Zambia
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nchelenge Facilities | – | Behavioral: Introduction of the Safe Childbirth ChecklistPurposively 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Introduction of the Safe Childbirth Checklist1. 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. | Behavioural | Nchelenge Facilities |
Primary outcome
Change in the average proportion of observed, SCC tasks completed per birth from selected task list
Time frame: Through study completion, an average of 6 months
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
4 secondary outcomes
Characteristics of health workers participating in facility-level SCC training
Time frame: Baseline
Feedback of health workers participating in facility-level SCC training
Time frame: Baseline
Feedback of health workers in participating facilities on SCC implementation
Time frame: 6 months
Feedback of health workers in participating facilities on SCC implementation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- BackgroundAlbolinoa 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.
- BackgroundAriadne Labs. Implementing Checklists for Quality Improvement: The Namibian Experience using the WHO Safe Childbirth Checklist.
- BackgroundCentral 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.
- BackgroundDavoodi 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.
- Background: PubMed 10342698Hayes 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.
- Background: PubMed 19144931Haynes 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.
- Background: PubMed 26271331Hirschhorn 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.
- Background: PubMed 27825321Kumar 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.
- BackgroundKumari 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: PubMed 24275499McCambridge 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.
- Background: PubMed 23962135Moyer 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.
- BackgroundMinistry of Health [Zambia]. Health Sector Payroll Data. January 2014.
- Maternal mortality factsheet. Updated November 2016Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. This is yet to be finalized with the Ministry of Health, Zambia.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Mudhune principal investigator
Clinton Health Access Initiative, Nigeria
Francis Bwalya principal investigator
Ministry of Health, Zambia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Death and Newborn Death, run by Clinton Health Access Initiative Inc. at 4 sites in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the average proportion of observed, SCC tasks completed per birth from selected task list (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03263182, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.