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.: PACTR202205688707819 Date of Approval: 04/05/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title CARBETOCIN COMPARED TO OXYTOCIN IN ACTIVE MANAGEMENT OF THIRD STAGE OF LABOUR IN AMINU KANO TEACHING HOSPITAL: A DOUBLE BLINDED RANDOMIZED CONTROLLED TRIAL
Official scientific title CARBETOCIN COMPARED TO OXYTOCIN IN ACTIVE MANAGEMENT OF THIRD STAGE OF LABOUR IN AMINU KANO TEACHING HOSPITAL: A DOUBLE BLINDED RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Postpartum hemorrhage (PPH) is a major contributor of maternal morbidity and the commonest cause of maternal mortality globally with sub-Saharan Africa contributing to a significant proportion of worldwide cases and deaths. The use of uterotonic agents has been recommended by health bodies like World Health Organization (WHO) in active management of third stage of labour to prevent PPH and its complications. The first line oxytocic (Oxytocin), however, has been fraught with some challenges in the prevention of PPH. Heat stable Carbetocin, being recommended as an alternative in low- and middle-income countries, may be more effective than Oxytocin in preventing PPH in such countries. The aim of the study is to compare the effectiveness of Carbetocin with Oxytocin in preventing postpartum haemorrhage in active management of third stage of labor (AMTSL) at Aminu Kano Teaching Hospital, Kano State. The Objectives of the study are: 1. To determine the proportion of women with blood loss >/= 500mls following vaginal delivery with use of Carbetocin versus Oxytocin 2. To estimate and compare amount of blood loss following vaginal delivery when Carbetocin is used compared to Oxytocin in AMTSL 3. To assess and compare the adverse effects, if any, of Carbetocin versus Oxytocin when used in AMTSL 4. To determine the cost effectiveness of Carbetocin in AMTSL
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Postpartum Haemorrhage
Purpose of the trial Prevention
Anticipated trial start date 01/08/2021
Actual trial start date 01/12/2021
Anticipated date of last follow up 01/10/2021
Actual Last follow-up date 01/04/2022
Anticipated target sample size (number of participants) 214
Actual target sample size (number of participants) 214
Recruitment status Completed
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Heat stable Carbetocin IM 100micrograms stat once It is a synthetic analogue of oxytocin with additional advantage of being heat stable. It has a longer duration of action. 107
Control Group Oxytocin IM 10IU stat Once It is a uterotonic agent which acts by binding to G protein-coupled receptors on the myometrium to cause uterine contractions. It is however heat labile and needs to be maintained in a cold chain between 2-8 degrees centigrades. 107 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All pregnant women • with singleton gestation • at term • at low risk of having PPH • in early active phase of first stage of labour who were to have spontaneous vaginal delivery 1. Pregnant women with medical disorders such as hepatic, cardiovascular, renal diseases, epilepsy, uncontrolled diabetes mellitus, sickle cell disease. 2. Gestational age <37 weeks. 3. Pregnant women with a previous caesarean scar, grandmultiparous women, multiple gestation, fetal macrosomia, previous PPH, anaemia, induction of labour, antepartum haemorrhage. 4. All pregnant women undergoing caesarean delivery. 5. Pregnant women in advanced labour and too distressed to provide informed consent. 6. Pregnant women in whom Oxytocin or Carbetocin are contraindicated: allergies to Oxytocin and its homologues. Adult: 19 Year-44 Year 19 Year(s) 44 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 18/03/2021 Research Ethics Committee Aminu Kano Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Aminu Kano Teaching Hospital Kano PMB 3452 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of women with blood loss >/=500mls in each group 1 hour after vaginal delivery
Secondary Outcome Mean blood loss at delivery (in mls) in each group 1 hour after vaginal delivery
Secondary Outcome Proportion of women receiving additional uterotonics within 1 hour of vaginal delivery
Secondary Outcome Proportion of women requiring additional surgical procedures (manual removal of placenta, uterine compression sutures, uterine or internal iliac artery ligation or hysterectomy) after vaginal delivery
Secondary Outcome Proportion of women needing blood transfusion after vaginal delivery
Secondary Outcome Side effects of drugs within 1 hour of vaginal delivery
Secondary Outcome Cost effectiveness ratio after data collection
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aminu Kano Teaching Hospital Zaria road, Kano Kano State Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Faiza Lawan Mohammed No 2 NNDC road, NNDC quarters, Kano Kano Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faiza Lawan Mohammed No 2 NNDC road NNDC quarters Kano Kano Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof Hadiza S. Galadanci Department of Obstetrics and Gynaecology, Aminu Kano Teaching Hospital Kano Nigeria
Dr Idris Usman Takai Department of Obstetrics and Gynaecology, Aminu Kano Teaching Hospital Kano Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faiza Lawan Mohammed muhdfaizalawan@gmail.com +2348033980709 No 2 NNDC road, NNDC quarters Kano
City Postal code Country Position/Affiliation
Kano Nigeria Resident Doctor
Role Name Email Phone Street address
Scientific Enquiries Hadiza Shehu Galadanci hgaladanci@yahoo.com +2348033210047 Aminu Kano Teaching Hospital
City Postal code Country Position/Affiliation
Kano Nigeria Professor of Obstetrics and Gynaecology
Role Name Email Phone Street address
Public Enquiries Maryam Bashir bashirmaryam@hotmail.com +971501741284 Institute of Public Health, CMHS
City Postal code Country Position/Affiliation
UAE United Arab Emirates Resaerch clinician
Role Name Email Phone Street address
Public Enquiries Idris Usman Takai takaiidris@yahoo.co.uk +2348035994552 Aminu Kano Teaching Hospital
City Postal code Country Position/Affiliation
Kano Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in active management of third stage of labour. Data shared will be coded. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party Clinical Study Report,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers that are engaged in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
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