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.: PACTR202211835951582 Date of Approval: 02/11/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title RANDOMIZED CONTROLLED STUDY COMPARING ORAL MISOPROSTOL WITH INTRAMUSCULAR OXYTOCIN IN ACTIVE MANAGEMENT OF THIRD STAGE OF LABOUR.
Official scientific title RANDOMIZED CONTROLLED STUDY COMPARING ORAL MISOPROSTOL WITH INTRAMUSCULAR OXYTOCIN IN ACTIVE MANAGEMENT OF THIRD STAGE OF LABOUR.
Brief summary describing the background and objectives of the trial Objective: To compare the effectiveness and side effects of 600µg of Oral Misoprostol with intramuscular 10 IU Oxytocin in active management of third stage of labour (AMTSL). Method: An open label randomized controlled trial carried out at Federal Medical Centre Bida, Nigeria. Two hundred and sixty consenting low risk women in second stage of labour with anticipated vaginal delivery were randomly assigned using computer generated number to receive in the third stage of labour, either Misoprostol 600µg orally or 1 ml of 10 IU oxytocin intramuscularly. The primary outcome measures were blood loss during delivery and proportion of postpartum haemorrhage. Analysis was by intention to treat. The level of significance was taken as p-values of ≤ 0.05. Results: Baseline characteristics were similar in both groups, PV >0.05 for all groups. Misoprostol group had a significantly lower blood loss at birth than oxytocin group (306.557 ± 176.44 VS 349.37 ± 135.50; RD -12.251 [CI -22.528, -1.575] PV 0.012). No difference in proportion of parturient that had postpartum haemorrhage between the Misoprostol and Oxytocin groups (RR 0.952 [CI 0.543-1.671] PV 0.865). Need for additional oxytocic was similar between the two groups (RR 1.143[CI 0.671-1.947] PV 0.623). Nausea, shivering and mean rise in temperature were significantly more common among the misoprostol than oxytocin parturient group. Conclusion: In this study, 600µg oral misoprostol was more effective in reducing blood loss at birth than intramuscular 10 IU oxytocin but was as effective as oxytocin in preventing postpartum haemorrhage. Misoprostol had more side effects than oxytocin. Keywords: Active management of third stage of labour, Vaginal delivery, Oral Misoprostol, Intramuscular Oxytocin, Effectiveness.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Active management of third stage of labour
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 02/10/2017
Actual trial start date 02/10/2017
Anticipated date of last follow up 30/03/2018
Actual Last follow-up date 30/03/2018
Anticipated target sample size (number of participants) 271
Actual target sample size (number of participants) 260
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Oxytocin group intramuscular 10 I.U Stat In a sealed envelope, instruction to give intramuscular 10 I.U Oxytocin was followed, within one minute after the delivery of the infant for active management of third stage of labour. 130 Active-Treatment of Control Group
Experimental Group Misoprostol group 600μg Oral Misoprostol Stat Stat In a sealed envelope, instruction to give 600μg oral misoprostol was followed, within one minute after the delivery of the infant for active management of third stage of labour. 130
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
No known risk factor for postpartum hemorrhage Booked parturient Gestational age of 37 to 40 weeks Those with haemoglobin concentration ≤ 10gm/dl. Haemoglobinopathies in pregnancy Chronic medical illnesses such as cardiac disease, Hypertensive disease and asthma in pregnancy Hyperthermia of > 37.2ᵒC Those that did not consent Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 35 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 31/07/2017 Health Research Ethics Committee Federal Medical Centre Bida Nigeria
Ethics Committee Address
Street address City Postal code Country
NO 4, Efu Etsu Yisa Bida, Niger State Nigeria Bida 912101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Blood loss after delivery and proportion of participants with PPH (>500ml) Primary outcomes were measured immediately after placenta was delivered to 1 hour postpartum
Secondary Outcome The secondary outcome measures were duration of third stage of labour, changes in maternal haemoglobin concentration , need for the use of additional oxytocic and the occurrences of adverse effects such as nausea, vomiting, diarrhoea, shivering and rise in temperature and retained placenta. Uptill 24 hours postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Bida Nigeria. Number 4 Etsu Efu Yissa street P.M.B 14, Bida, Niger State Nigeria Bida 912101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Sambo Atanda Abdulrasaq 4 Efu Etsu Yisa Street, P.M.B 14 Bida Niger State Nigeria Bida 912101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Sambo Atanda Abdulrasaq 4 Efu Etsu Yisa P.M.B 14 Bida, Niger State Nigeria Bida 912101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdulrasaq Sambo sarasaq@yahoo.com +2348052336310 4 Efu Etsu Yisa P.M.B. 14 Bida, Niger State Nigeria
City Postal code Country Position/Affiliation
Bida 912101 Nigeria Obstetrician and Gynecologist
Role Name Email Phone Street address
Public Enquiries Abdulrasaq Sambo sarasaq@yahoo.com +2348052336310 4 Efu Etsu Yisa , P.M.B 14 Bida, Niger State Nigeria
City Postal code Country Position/Affiliation
Bida 912101 Nigeria Obstetrician and Gynecologist
Role Name Email Phone Street address
Scientific Enquiries Munirdeen Ijaiya munirijaiya@yahoo.com +2348033801565 University of Ilorin Teaching Hospital / University of Ilorin, Ilorin Kwara State
City Postal code Country Position/Affiliation
Ilorin 240003 Nigeria Obstetrician and Gynecologist
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 will be shared Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, no end date. Access to IPD can be done via sarasaq@yahoo.com interested researchers.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 30/10/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 30/10/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information