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: pactr.samrc.ac.za
Trial no.: PACTR202302476608339 Date of Approval: 10/02/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Heat-stable carbetocin and tranexamic acid for postpartum hemorrhage prevention and treatment in basic emergency obstetric care facilities in fragile and humanitarian settings in South Sudan and Uganda
Official scientific title Heat-stable carbetocin and tranexamic acid for postpartum hemorrhage prevention and treatment in basic emergency obstetric care facilities: protocol for a complex mixed-method study in fragile and humanitarian settings in South Sudan and Uganda
Brief summary describing the background and objectives of the trial Background: in hospital-based settings, heat-stable carbetocin (HSC) is shown to be effective for postpartum hemorrhage (PPH) prevention, and tranexamic acid (TXA) for PPH treatment. Neither HSC nor TXA require cold chain systems and could play a critical role in resource-constrained settings. There is limited documentation of how these medications are implemented in such settings. Objectives: this implementation research aims to identify a package of HSC- and TXA-inclusive PPH interventions designed to strengthen existing basic obstetric services in humanitarian settings and evaluate trends in the use of HSC and TXA.
Type of trial CCT
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 Intervention research on HSC for PPH prevention and TXA for PPH treatment
Anticipated trial start date 01/01/2022
Actual trial start date 01/02/2022
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 1008
Actual target sample size (number of participants)
Recruitment status 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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Routine PPH prevention and treatment care 2 months Routine care based on: - National guidance for PPH prevention - National guidance for PPH treatment 252 Historical
Experimental Group Package of intervention without HSC or TXA 2 months Refresher course on PPH prevention and treatment Pre-positioned medication, products and instruments for PPH treatment 252
Experimental Group Package of intervention with HSC but without TXA 2 months As in previous phase but with the introduction of HSC 252
Experimental Group Package of intervention with HSC and TXA 2 months As in previous phase, but with the addition of TXA 252
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A woman will be eligible to participate in the study after she has (1) given birth at the facility and (2) provided informed consent (which will be done during the postpartum period before her discharge from the facility). Adult participants will give their informed consent. Non-adult participants will give their informed assent and their respective parents or guardians their informed consent. (1) has not given birth at the facility (2) has not provided informed consent Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 13 Year(s) 49 Year(s) Female
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
Yes 25/07/2022 MOH RERB
Ethics Committee Address
Street address City Postal code Country
Ministerial Complex, Ministries Road Juba -- Sudan
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/10/2022 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road, Ntinda Kampala n/a Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1) proportion of birthing women receiving a uterotonic for PPH prevention. This overall proportion will be broken down by type of uterotonics that are available (e.g., oxytocin, misoprostol) or will be made available (HSC) in facilities; At 2, 4, 6 months
Primary Outcome (2) proportion of women with clinical PPH receiving a uterotonic for PPH treatment (e.g., oxytocin, misoprostol); At 2, 4, 6 months
Secondary Outcome (3) proportion of women with clinical PPH receiving TXA for PPH treatment. At 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bentiu BEmONC center Sector 4, Block II Bentiu South Sud Sudan
Bentiu II BEmONC center Bentiu Rubkona Bentiu South Sud Sudan
Malakal BEmONC center n/a Malakal South Sud Sudan
Mingkaman BEmONC center Lake State, Awarial Mingkaman South Sud Sudan
Wau BEmONC center W Bahr El Ghazal Wau South Sud Sudan
Juba BEmONC Center Juba POC III Juba South Sud Sudan
Barakala Health centre III Bidibidi Refugee Settlement Aringa East West Nile Uganda
Bidibidi Health Centre III Bidibidi Refugee Settlement Aringa East West Nile Uganda
Ucea Health centre II Imvepi Refugee settlement Madi Okollo West Nile Uganda
Uriama Health Centre III Rhino Camp Refugee settlement Terego Uganda
Yinga Health Centre III Imvepi Refugee settlement. Odupi Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Ferring Chem. de la Vergognausaz 50 Saint Prex 1162 Switzerland
UNFPA 605 Third Avenue New York United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UNFPA Humanitarian Division rue de Varembe 7 Geneva Switzerland United Nations
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nguyen Toan Tran nguyentoan.tran@uts.edu.au +41795358374 235 Jones St
City Postal code Country Position/Affiliation
Ultimo Australia Adjunct Professor
Role Name Email Phone Street address
Public Enquiries Catrin Schulte Hillen schulte-hillen@unfpa.org +33631367376 7 rue de Varembe
City Postal code Country Position/Affiliation
Geneva Switzerland Technical Advisor
Role Name Email Phone Street address
Scientific Enquiries Catrin Schulte Hillen schulte-hillen@unfpa.org +33631367376 7 rue de Varembe
City Postal code Country Position/Affiliation
Geneva Switzerland Technical Advisor
Role Name Email Phone Street address
Public Enquiries Raphael Okpwoku sukere sukere@unfpa.org +211929257248 UN House, Building 4, Yei Road
City Postal code Country Position/Affiliation
Juba South Sud Sudan UNFPA study coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share all deidentified individual trial participant data. The data will be available in an open source repository. Study Protocol It will be available to all researchers at the time of the main results publication. There will be no time limitation. Open
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