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.: PACTR202310568262804 Date of Approval: 12/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of combined misoprostol and oxytocin with oxytocin alone in the control of blood loss during elective caesarean section.
Official scientific title Comparison of combined misoprostol and oxytocin with oxytocin alone in the control of blood loss during elective caesarean section.
Brief summary describing the background and objectives of the trial BACKGROUND: Increasing Caesarean section rate is a source of concern to obstetricians due to the attendant increased health risk. The commonest complication is postpartum haemorrhage, which can be life-threatening. The current World Health Organization (WHO) recommendation for preventing PPH is 10 IU (international units) of intramuscular or intravenous oxytocin. Despite these, PPH has continued to be the leading cause of morbidity and mortality during Caesarean section. There are several uterotonic agents for preventing PPH; however, there is still uncertainty about which agent is most effective with the least side effects. OBJECTIVE: To compare the use of combined misoprostol-oxytocin with that of oxytocin alone in the control of blood loss during elective caesarean section at the Federal Medical Centre, Keffi.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/06/2022
Actual trial start date 29/06/2022
Anticipated date of last follow up 29/12/2022
Actual Last follow-up date 23/01/2023
Anticipated target sample size (number of participants) 174
Actual target sample size (number of participants) 171
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Combined misoprostol and oxytocin 200 µg of misoprostol sublingually and 5 IU oxytocin bolus intravenously immediately after delivery of the neonate This was a double-blind randomised controlled study, conducted within 7 months. Participants were randomised into two groups: Group A received 200 µg of misoprostol sublingually and 5 IU oxytocin bolus intravenously immediately after delivery of the neonate. The primary outcome measure was blood loss (intra-operative and postpartum within 24 hours of delivery) estimated in millilitres. The secondary outcome measures included; a significant change in pre- and post-delivery haematocrit, the need for additional uterotonic interventions in the 24 hours following delivery to maintain proper uterine tone, the need for blood transfusion, and medication side effects such as fever, headache, shivering, nausea, vomiting, and hypotension. 86
Control Group Oxytocin plus placebo 10 IU oxytocin bolus intravenously and one tablet of placebo (vitamin C) sublingually immediately after delivery of the neonate This was a double-blind randomised controlled study, conducted within 7 months. Participants were randomised into two groups: Those in the oxytocin + placebo group (Group B) received 10 IU oxytocin bolus intravenously and one tablet of placebo (vitamin C) sublingually, also immediately after delivery of the neonate. The primary outcome measure was blood loss (intra-operative and postpartum within 24 hours of delivery) estimated in millilitres. The secondary outcome measures included; a significant change in pre- and post-delivery haematocrit, the need for additional uterotonic interventions in the 24 hours following delivery to maintain proper uterine tone, the need for blood transfusion, and medication side effects such as fever, headache, shivering, nausea, vomiting, and hypotension. 85 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consenting women with term pregnancies undergoing elective lower segment caesarean delivery under spinal anaesthesia. Women with predisposing factors for PPH, such as; Multiple gestations, Placenta praevia, Undiagnosed vaginal bleeding, were excluded from the study. Patients who had general anaesthesia Patients with surgical indications requiring general anaesthesia, cardiovascular, renal, or hepatic dysfunction. Patients who presented with fever or refused to give consent were excluded. Adult: 19 Year-44 Year 19 Year(s) 40 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 20/12/2021 Federal Medical Centre Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Along Old Akwanga Road, Keffi Nasarawa State Keffi 961101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure was blood loss (intra-operative and postpartum within 24 hours of delivery) estimated in millilitres. within 24 hours of delivery
Secondary Outcome The secondary outcome measures included; a significant change in pre- and post-delivery haematocrit, the need for additional uterotonic interventions in the 24 hours following delivery to maintain proper uterine tone, the need for blood transfusion, and medication side effects such as fever, headache, shivering, nausea, vomiting, and hypotension. within 24 hours of delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Keffi Along Old Akwanga Road, Keffi Nasarawa State Keffi Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Victoria Felix Fom No 2 Anthony Olatuoye Crescent, Old Karu Road Mararaba Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Federal Government of Nigeria Abuja Abuja Nigeria Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Victoria Felix Fom fomverita@yahoo.com +2348056090580 No 2 Anthony Olatuoye Crescent Old Karu Road
City Postal code Country Position/Affiliation
Mararaba Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Olubunmi Tunde Olatunji olubunmiolatunji@gmail.com +2348035863359 Keffi
City Postal code Country Position/Affiliation
Keffi Nasarawa Nigeria Medical Consultant
Role Name Email Phone Street address
Scientific Enquiries Samuel Pam sampbet2@yahoo.com +2348034521843 Keffi Nasarawa
City Postal code Country Position/Affiliation
Keffi Nigeria Medical Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 9 months and ending 36 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose
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