Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR202001484669907 Date of Approval: 21/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of a modified WHO Safe childbirth checklist (WHO-SCC) in preventing poor childbirth outcomes
Official scientific title Effectiveness of a modified WHO Safe childbirth checklist (WHO-SCC) in preventing poor childbirth outcomes: a matched pair cluster randomized controlled trial
Brief summary describing the background and objectives of the trial The global efforts towards achievement of the 2015 Millennium Development Goals (MDGs) have led to substantial improvement in facility-based child births rates as compared to home deliveries, particularly in sub-Saharan Africa, one of the most affected regions by maternal deaths in the world. Yet, maternal and newborns mortality and morbidity rates remain unacceptably high and far above the expected levels. Poor-quality care at health facilities in low-resource settings is also regarded as a major contributing factor to preventable maternal and newborn deaths and disability, justifying why the shift of childbirths from home to health facilities has not been sufficient to reducing maternal and newborns deaths. Quality of care improvement strategies appear to be important and needed as the health facility utilization is raising. The objectives of the intervention study are: • To measure the effectiveness of a modified WHO-SCC in improving health care providers’ adherence to EBPs during intrapartum and immediate postpartum care; • To assess the effectiveness of modified WHO-SCC in improving the availability of safe childbirth supplies; • To assess the effectiveness of the implementation of a modified WHO-SCC in preventing poor childbirth outcomes in under-resourced settings of SSA
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/03/2020
Actual trial start date
Anticipated date of last follow up 30/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 7590
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard of care. No intervention six months in the control group, only the standard of care will prevail. no modification of childbirth practices is planned 3795 Active-Treatment of Control Group
Experimental Group Modified WHO safe childbirth checklist WHOSCC and refresh trainings of providers six months The intervention will encompass the introduction of a modified WHO-SCC in health facilities and trainings of health care providers on good childbirth practices. The modified Safe Childbirth Checklist (SCC) will be introduced in intervention health facilities following a coaching-based approach. The SCC, as a job aid tool that prompts health workers to remember essential best care practices that a woman and/or her new-born must receive at four critical junctures during intrapartum and immediate postpartum periods, will be adapted from the WHO-SCC to reflect local contexts and align to the national guidelines. The SCC will be introduced in intervention facilities using a combination of two approaches that were identified as the most effective and acceptable ways for its introduction during the formative research. The first way is to reproduce the SCC in a larger format that will be displayed in the delivery room at the bedside of the woman, allowing health care providers to have a glance on it at any time while caring for the mother-new-born pair. Similar approaches are used with the guidelines for the management of post-partum haemorrhage and were found effective by most of the health care providers during the formative phase. This approach, while effective in prompting on EBPs at any time, does not however, allow the utilization of the SCC as a documentation tool of EBPs in addition. To allow the utilization of the SCC as a documentation tool as well, we will combine the displaying in delivery room with the attachment of a copy to the partograph. 3795
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women admitted in the delivery room of participating health facilities for delivery labour during the study recruitment period along with their new-borns - All the women who were admitted in the childbirth room for elective caesarian section (before the labour has begun) - All the women and their newborns that were transferred for additional care after a delivery outside of the participating health facility and those received for any other type of obstetric care not related to childbirth (abortions, miscarriages and antenatal care). - Pregnant women referred to higher level of care upon admission without proper administration of care at the level of the participating health facility will also be excluded. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month 0 Day(s) 45 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 17/02/2020 Comite ethique pour lab recherche en sante
Ethics Committee Address
Street address City Postal code Country
1200 logements Ouagadougou 7009 Burkina Faso
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Composite outcome of poor childbirth outcome: Stillbirths, maternal deaths, early neonatal deaths, Severe postpartum hemorrhage, maternal infections, early neonatal infections, obstructed labor, severe pre-eclampsia, uterine rupture in the health facility, eclampsia and near miss. Any time from admission for childbirth to seven days postpartum
Secondary Outcome Level of adherence to essential best practices during the course of childbirth Admission, Just before pushing, immediate postpartum within 1h, just before discharge from hospital
Secondary Outcome Availability of safe childbirth supplies Zero and six months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institut de Recherche en Sciences de la Sante 03 Wemtenga Ouagadougou 7192 Burkina Faso
Institut National de Sante Publique Abidjan V47 Abidjan 0047 Cote Divoire
Cellule de recherche en sante de la reproduction en Guinee conakry Conakry Guinea
FUNDING SOURCES
Name of source Street address City Postal code Country
World Health Organization Human Reproduction program Avenue Appia 20 Geneva 1211 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor World Health Organization Human Reproduction Program 20, avenue APPIA CH Geneva 1211 Switzerland Funding Agency
COLLABORATORS
Name Street address City Postal code Country
AGBRE MARIE LAURETTE YACE Abidjan V47 Abidjan Cote Divoire
BALDE Mamadou Dioulde Belle vue miniere immeble Hadja Adama Conakry Guinea
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Seni Kouanda senikouanda@gmail.com +22670261462 bureau, wemtenga
City Postal code Country Position/Affiliation
Ouagadougou 0050 Burkina Faso Senior researcher Institut de recherche en sciences de la sant
Role Name Email Phone Street address
Scientific Enquiries Seni kouanda senikouanda@gmail.com +22670261462 rue, wemtenga
City Postal code Country Position/Affiliation
Ouagadougou 0050 Burkina Faso Senior researcher Institut de recherche en sciences de la sante
Role Name Email Phone Street address
Public Enquiries Tieba Millogo millogorod@gmail.com +22671910013 rue St Thomas d Aquin
City Postal code Country Position/Affiliation
Ouagadougou 0199 Burkina Faso Assistant Professor African Institute of Public Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share a summary of key findings of the trial: primary and secondary outcomes Clinical Study Report,Study Protocol within 12 months of the end of the recruitment Publicly available
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 19/01/2020 To correct an inconsistance raise by the revision. CCT RCT
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 19/01/2020 Information on funding source was missing in the previous submission. We are adding the information to address the review comment World Health Organization Human Reproduction program, Avenue Appia 20, Geneva, 1211, Switzerland, Funding Agency,
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 19/01/2020 Information previously missing AGBRE MARIE LAURETTE YACE, Abidjan V47, Abidjan, , Cote Divoire
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 19/01/2020 Information previously missing BALDE Mamadou Dioulde, Belle vue miniere immeble Hadja Adama, Conakry, , Guinea
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 19/01/2020 To address review comments Undecided Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 19/01/2020 To address review comments We will share a summary of key findings of the trial: primary and secondary outcomes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 19/01/2020 To address review comments within 12 months of the end of the recruitment
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 19/01/2020 To address review comments Publicly available
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 19/01/2020 To address review comments Study Protocol, Clinical Study Report