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.: PACTR202310744034060 Date of Approval: 03/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety And Efficacy Sublingual Misoprostol Versus Vaginal Misoprostol.
Official scientific title Safety And Efficacy Of Sublingual Versus Vaginal Misoprostol For Labour Induction Among Primigravida At Term: A Randomised Controlled Trial
Brief summary describing the background and objectives of the trial Background: Planned induction of labour for a variety of reasons has become a common procedure in contemporary obstetric practice. Although the effectiveness of misoprostol, a prostaglandin E1 analog, as a cervical ripening and labour induction agent has been demonstrated, research continues to be conducted to determine the best route and dosage. This study is expected to boost the already existing evidence on use of misoprostol and provide local based data and guidance to take appropriate decision on route of administration of prostaglandin E1 agent often used for cervical ripening and induction of labour among primigravida at term. Objectives: The aim of this study is to determine the safety and efficacy of 25mcg sublingual versus 50mcg vaginal misoprostol for induction of labour among primigravida at term. Methodology: This study will be a randomized open-labeled parallel non-inferiority clinical trial involving eighty-two (82) women who have met the inclusion criteria and have consented to be part of the study. The women will be divided into two equal groups (sublingual and vaginal) and given either 25mcg of misoprostol sublingually or 50mcg of misoprostol vaginally, from a table of random numbers using simple random sampling technique. The study's two arms' efficacy and safety results will be compared. Proposed Analysis: The study will analyze respondents' sociodemographic characteristics, determine the fetomaternal outcome, compare the maternal outcome in the two different groups, compare the perinatal outcome in the two different groups, and determine participants' level of satisfaction. Data will be analyzed using IBM SPSS version 24.0 software, and the test of statistics will be done with Chi-square, Fisher’s exact test and student T-test. A p-value <0.05 will be significant. The variables which will be categorical and continuous will be presented in frequency tables and charts, and their means and standard deviations will be calculated where applicable. The expected outcome of this study is to demonstrate if, 25mcg sublingual misoprostol for induction of labour in primigravida at term with appropriate indication is as effective and safe as well as more satisfactory than the use of 50mcg vaginal misoprostol.
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 Labour induction outcome
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2023
Actual trial start date
Anticipated date of last follow up 31/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 82
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL Not applicable
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
Experimental Group sublingual misoprostol arm 25 micro gram every four hours (maximum of 6 doses) 24 hours All the participants who received sublingual misoprostol will be asked to keep the tablet under the tongue and not to swallow the tablet for 20 minutes to enable it dissolve and get absorbed, this will be by directly observed therapy. 41
Control Group Vaginal misoprostol arm as standard treatment arm 50 microgram misoprostol every 4 hours (maximum of 6 doses) 24 hours The patients who received vaginal misoprostol will be asked not to stand up or move around after the insertion of the vaginal tablet for about 30mins from insertion to prevent displacement of the tablet from the posterior fornix. 41 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Prigravida Gestational age ≥37 to 42 weeks. Participants who have indication for induction of Labour. Cervical assessment with Modified Bishops score value of less than 6. Singleton gestation. Cephalic presentation. Optimal biophysical profile. Participants who gave written consent to participate in the study. Teenage pregnancy. Participants who withdraw consent even after being enrolled into the sudy. All indications for Cesarean section. Participants with relative or absolute contraindications to misoprostol use (e.g.; misoprostol allergies, Acute Cerebrovascular Disease, Coronary Artery Disease, epileptics). A history of extensive uterine surgery. Abnormal vaginal bleeding. An unconscious patient. Adult: 19 Year-44 Year 20 Year(s) 45 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 28/08/2023 IRRUA SPECIALIST TEACHING HOSPITAL HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
KM 87 BENIN-AUCHI ROAD, IRRUA, EDO STATE IRRUA P.M.B 8 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean interval from the first dose of misoprostol to onset of adequate uterine contraction in both groups and mean induction of labour - delivery interval. Intrapartum
Secondary Outcome Mean doses of misoprostol required for IOL in both groups. Proportion of women who require oxytocin augmentation in both groups. Proportion of women who achieve vaginal delivery in both groups. Proportion of women who required caesarean delivery in both groups. Intrapartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
IRRUA SPECIALIST TEACHING HOSPITAL Km 87, BENIN-AUCHI EXPRESS ROAD, IRRUA, EDO STATE IRRUA P.M.B 8 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Out of pocket KM 87 Benin-Auchi express road, Irrua, Edo State. Irrua P.M.B 8 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Aituma Lewis Osadebamwen KM 87, Benin - Auchi express road, Irrua, Edo State Irrua P.M.B 8 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Osadebamwen Aituma aitumalewis@gmail.com 08131999547 KM 87, Benin-Auchi express road, Irrua, Edo State
City Postal code Country Position/Affiliation
Irrua P.M.B 8 Nigeria Senior Resident at Irrua specialist Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Yemihan Ogbetere yemihanogbetere@gmail.com +2348030770741 KM 87, Benin-Auchi express road, Irrua, Edo State
City Postal code Country Position/Affiliation
Irrua P.M.B 8 Nigeria ISTH HREC Administrator and Consultant Public Health Physician
Role Name Email Phone Street address
Scientific Enquiries Osadebamwen Aituma aitumalewis@gmail.com +2348131999547 KM 87, Benin-Auchi express road, Irrua, Edo State
City Postal code Country Position/Affiliation
Irrua P.M.B 8 Nigeria Senior Resident at Irrua Specialist Teaching Hospital
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). Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication. No end date Investigators whose proposed use of the data has been approved by an independent review committee(“learned intermediary”)identified for this purpose. For Individual participant data meta-analysis.
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