Evaluating the Impact of the WHO’s Safe Childbirth Checklist in Indonesia – A Randomized Controlled Trial

Last registered on November 11, 2018

Pre-Trial

Trial Information

General Information

Title
Evaluating the Impact of the WHO’s Safe Childbirth Checklist in Indonesia – A Randomized Controlled Trial
RCT ID
AEARCTR-0003548
Initial registration date
November 08, 2018
Last updated
November 11, 2018, 6:21 PM EST

Locations

Region

Primary Investigator

Affiliation
Georg-August University of Goettingen

Other Primary Investigator(s)

PI Affiliation
Syiah Kuala University
PI Affiliation
Syiah Kuala University
PI Affiliation
Syiah Kuala University
PI Affiliation
Syiah Kuala University
PI Affiliation
Syiah Kuala University
PI Affiliation
Syiah Kuala University
PI Affiliation
Syiah Kuala University
PI Affiliation
University of Mannheim
PI Affiliation
Georg-August University of Goettingen

Additional Trial Information

Status
Completed
Start date
2016-07-01
End date
2018-02-01
Secondary IDs
ISRCTN11041580
Abstract
Background: The birth process remains to be a critical and highly risky period in mothers´ and children´s lives and accounts for half of all child deaths. Based on the success of checklist programs in other disciplines, the World Health Organisation (WHO) developed the Safe Childbirth Checklist (SCC) – a tool that targets the major causes of maternal and newborn mortality. The trial aims to evaluate the effectiveness of the WHO’s Safe Childbirth Checklist (SCC) in combination with a light coaching approach.

External Link(s)

Registration Citation

Citation
, et al. 2018. "Evaluating the Impact of the WHO’s Safe Childbirth Checklist in Indonesia – A Randomized Controlled Trial." AEA RCT Registry. November 11. https://doi.org/10.1257/rct.3548-1.0
Former Citation
, et al. 2018. "Evaluating the Impact of the WHO’s Safe Childbirth Checklist in Indonesia – A Randomized Controlled Trial." AEA RCT Registry. November 11. https://www.socialscienceregistry.org/trials/3548/history/37048
Experimental Details

Interventions

Intervention(s)
It is recognized that a “one size fits all” checklist would not be feasible for all settings, and the SCC is intentionally not comprehensive. Modification is encouraged to reflect local practice and foster ownership, and may include content changes to specific checklist items or to the qualifying caption boxes. We adapted the pilot edition SCC to the Indonesian context with the help of experts, including paediatricians and gynaecologists, midwives, and more coming from different health facility levels (see Appendix A for the adapted Acehnese pilot edition of SCC).

In treatment sites, the SCC is introduced in the obstetrics unit in the health facilities and is intended for use at four critical junctures in clinical care around the time of birth: on admission of the mother; at the time the mother begins to push (or before caesarean delivery); soon after birth (within one hour); and before discharge. Intervention sites sent their facility representatives to the same information event and participated both in observations and surveys for data collection purposes. Above that, the intervention sites were exposed to four treatment components (i) an introductory event, (ii) provision of the checklist and danger sign information sheets, (iii) inter-facility staff meetings and (iv) monitoring visits. The introductory event consisted of a two hour presentation, explaining the motivation of the checklist and its application, supported by a role play. Moreover, during the event a facility based (non-remunerated) checklist quality coordinator (CQC) was selected, who was responsible for the SCC implementation. Those (iii) CQCs met twice after three and six months after introduction for a two hour focus group discussion including exchange of best practice. (iv) Eleven monitoring visits were carried out over six months, taking each two hours. Those meetings served the provision of new checklists and collection of used checklists, which will ensure adherence to the intervention. Moreover, feedback on previous performance was given and face-to-face interviews with the monitoring team offered the opportunity to ask questions on potential barriers in checklist implementation from both sides.

The control sites participated in an information event, which was designed to inform the facility leadership about the SCC and ask for informed consent. Moreover, for data collection purposes the midwives were exposed to observations as well as the survey on socio-demographic details and perceptions. After selecting comparable sets of facilities via an optimization approach by Schlather & Schneider (2017), comparison facilities were selected via a randomization approach.
Intervention Start Date
2016-10-01
Intervention End Date
2017-06-01

Primary Outcomes

Primary Outcomes (end points)
Our study will primarily focus on the changes in observed behaviour by measuring potential changes in applied essential birth practices between treatment and control group. As we are additionally interested in the interaction with practitioners’ perceptions, further data were collected in individual practitioner surveys addressing the topics (1) quality of care, (2) referral perceptions, (3) working structure, (4) information & communication, (5) knowledge, (6) motivation, (7) empowerment, (8) reminding and (9) the coaching process.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
As the checklist is designed to ultimately reduce mortality and morbidity among mothers and children, we also collect data on health outcomes from facilities and use those to construct comparable rates based on delivery numbers. This data is already reported for governmental usage in the majority of health facilities. Here, the quality of the data collection by each Intervention Unit needs to be ensured. If possible it will be tried to follow-up on patient fatality cases after discharge to be able to report postpartum mortality rates adequately. Another important outcome is birth complications, which can lead to short- and long-term morbidities of mother and child. Many checklist items are aiming at minimizing easily preventable conditions, like birth asphyxia, bacterial sepsis, and hypothermia.
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The study will be designed as a randomized controlled trial. It will comprise health facilities that are offering delivery services in Aceh Province in the North of Sumatra Island. We will randomly start to implement the SCC together with a checklist specific training in about 50% of the health institutions selected for the study. The checklist will be applied by midwives during standard deliveries for six months. This study design allows us to establish two groups of health facilities (treatment and control group) to causally identify the effect of the intervention on the selected outcomes. If the instrument proves to be effective all participating health facilities will gain access to the instrument.
Experimental Design Details
Randomization Method
Using an optimization matching approach by (Schlather & Schneider, 2017), we obtain a counterfactual, which enables a thorough statistical identification of potential treatment effects. Both treatment and control sites contained the same number of facilities. The allocation sequence was randomized at the facility level.
Randomization Unit
We cluster at the unit of the health facility.
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
32 Health Facilities
Sample size: planned number of observations
We plan to interview two thirds of facility staff (~400 persons, based on baseline staffing of around 600 providers) and observe deliveries during one week of facility practice (~240 deliveries, based on a yearly birthload of around 12,000 deliveries).
Sample size (or number of clusters) by treatment arms
We sampled 16 facilities in the treatment group and 16 facilities in the control group.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials

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IRB

Institutional Review Boards (IRBs)

IRB Name
Ethical Clearance Committee of the Medical Faculty of Syiah Kuala University
IRB Approval Date
2016-06-24
IRB Approval Number
08/KE/FK/2016
IRB Name
Ethical Review Board of the University of Göttingen
IRB Approval Date
2016-06-27
IRB Approval Number
NA

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
June 01, 2017, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
February 01, 2018, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
Final Sample Size (or Number of Clusters) by Treatment Arms
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials