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.: PACTR202201742377791 Date of Approval: 21/01/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A COMPARISON OF OXYTOCIN -MISOPROSTOL COMBINATION AND CARBETOCIN IN REDUCING BLOOD LOSS AT CAESAREAN SECTION: A RANDOMISED CONTROLLED STUDY
Official scientific title A comparison of oxytocin -misoprostol combination and carbetocin in reducing blood loss at caesarean section: a randomised controlled study
Brief summary describing the background and objectives of the trial Obstetric haemorrhage still accounts for an estimated 25% of global maternal deaths despite considerable scientific advances made at discerning its causation, prevention and effective treatment. Caesarean section is a common obstetric procedure performed worldwide and haemorrhage at Caesarean section is a significant contributor to the burden of obstetric haemorrhage in sub-Saharan Africa Several efforts have been made for reducing blood loss at Caesarean section among which is the use of oxytocic to improve uterine contractility. Despite all of these interventions, haemorrhage is still a major concern.
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 Education /Training
Anticipated trial start date 05/07/2021
Actual trial start date
Anticipated date of last follow up 31/08/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants)
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group carbetocin carbetocijn 100mcg single dose two months 100 mcg of carbetocin given at Caesarean section after the delivery of the fetus 80 Active-Treatment of Control Group
Experimental Group Oxytocin misoprostol combination Intravenous oxytocin 10 iu Sublingual misoprostol 600mcg 2 month Intravenous oxytocin 10 iu and sublingual misoprostol 600mcg is given after the delivery of the fetus at Caesrean section 80
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. All consenting pregnant women undergoing elective or emergency Caesarean section 2. Failed induction of labour 3. Pregnant women with obstructed labour 4. Pregnant women with antepartum haemorrhage secondary to placenta previae 5. Two or more Caesarean section 6. Grand multiparous women 1. Those who were not counselled because of the emergency nature of their surgery 2. Pregnant women with uterine rupture 3. Pregnant women with bleeding disorders 4. Women receiving general anaesthesia for surgery Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 28/09/2021 university of benin teaching hospital
Ethics Committee Address
Street address City Postal code Country
ugbowo benin 1111 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To determine Efficacy of use of oxytocin-misoprostol combination and carbetocin in reducing blood loss at Caesarean section. To determine the average blood loss at surgery between the two study group. To determine the need for additional uterotonic agents between the two study group. After the Caesarean section
Secondary Outcome To compare the rate of postpartum haemorrhage between both groups and need for blood transfusion, to determine the differences in haematocrit concentration 12hours before and 48hours after surgery, to compare the adverse effects of the medication between the two group 12 hours before surgery, immediate post surgery and 48 hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
university of benin teaching hospital ugbowo benin city Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
sofiat ayobami yusuf block e flat 4 dentistry quaters ugbowo benin city Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sofiat ayobami yusuf block e flat 4 dentistry quaters benin Nigeria self sponsorship
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator sofiat ayobami yusuf sofiat_yusuf@yahoo.com +2348032031560 block e flat 4 dentistry quaters, ugbowo
City Postal code Country Position/Affiliation
benin city Nigeria specialist obstetrician gynaecologist
Role Name Email Phone Street address
Public Enquiries Adedapo Ande tundeande@gmail.com +2348023522257 department of obstetrics and gynaecology, university of benin teaching hospital
City Postal code Country Position/Affiliation
benin Nigeria professor of obstetrics and gynaecology
Role Name Email Phone Street address
Scientific Enquiries Ignis Iribhogbe droseihie@gmail.com +2348033787700 department of obstetrics and gynaecology, university of benin teaching hospital
City Postal code Country Position/Affiliation
benin city Nigeria consultant obstetrician gynaecologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participants data will be available Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol two years 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