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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202508848595542 Date of Registration: 29/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of Misoprostol With Foley's Catheter Versus Misoprostol Alone for Induction of Labour
Official scientific title Comparison of Misoprostol plus Foley's Catheter versus Misoprostol Alone For Induction Of Labour: A Randomized Controlled Trial In The Gambia
Brief summary describing the background and objectives of the trial Induction of labour (IOL) is one of the common obstetrics interventions, and it is defined as the artificial stimulation or initiation of labour, after the age of viability and before the onset of spontaneous labour, which will lead to uterine contractions and alteration in cervix in order to facilitate vaginal delivery. It is usually performed when the benefit of delivery of the baby surpasses the risk of waiting for spontaneous labour and there are no contraindications to vaginal delivery. OBJECTIVES: 1. To describe the sociodemographic characteristics of patients scheduled for induction of labour 2. To determine the induction delivery interval in each group: the group A (misoprostol only) and group B (combined misoprostol plus foley catheter) 3. To compare the induction to delivery interval between the group A (misoprostol only) and group B (combined misoprostol and foley catheter) 4. To compare the incidence of the common complications risk between those who used misoprostol alone or misoprostol and foleys catheter for induction of labour
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 Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2025
Actual trial start date 07/07/2025
Anticipated date of last follow up 31/12/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 234
Actual target sample size (number of participants) 234
Recruitment status Recruiting
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
Experimental Group Foley catheter plus misoprostol Foley catheter size 18( once) misoprostol 50mcg (4 doses) 6 months The catheter will be inserted in to cervix and inflated with 60ml of normal saline plus 50 mcg of misoprostol given vaginally 6 hourly 117
Control Group misoprostol only misoprostol 50mcg 6 hourly for 24 hours 6 months misoprostol will be given vaginally every 6 hours 117 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• All pregnant women who have indications for induction of labour at a gestational age of at least 34 weeks • Women that are primigravida to para 3 • Patients who are informed, counselled and consented to participate in the study • All patients with multiple gestations • Those who did not consent • Those with previous caesarean section • Those with precious uterine scar • Antepartum haemorrhage • Patients with uncontrolled medical conditions, e.g. hypertension, sickle cell disease, diabetes • Intrauterine foetal death • Prom Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 49 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 05/02/2025 Research Ethics Committee Edward Francis Small Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Independence drive, Banjul Banjul 1515 Gambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1.Induction delivery interval for the intervention and the control group. Success rate of the induction of labour in the two groups pregnant women at 34 weeks of pregnancy to post term
Secondary Outcome 1.Post partum hemorrhage. 2. Birth Asphyxia . Post Partum period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bundung Maternal and Child Hospital Bundunka kunda Banjul Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Postgraduate office of The Gambia at the Edward Francis Small Teaching Hospital Independence drive Banjul Gambia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Postgraduate office Independence drive Banjul Gambia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dado Jabbie jabbiedado29@gmail.com 2207933758 Independence drive
City Postal code Country Position/Affiliation
Banjul Gambia Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Sesan Oluwasola sesanoluwasola@gmail.com +234803334064 Ibandan
City Postal code Country Position/Affiliation
Ibadan Nigeria Consultant
Role Name Email Phone Street address
Public Enquiries Mustapha Bittaye bittaye@yahoo.com +2203113512 Independence drive
City Postal code Country Position/Affiliation
Banjul Gambia Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participants data will be available if requested by a qualified researcher after de-identification. Data will be available 6 months after publication for up to 3 years from the lead investigator. For request contact jabbiedado29@gmail.com Informed Consent Form 3 years controlled
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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 29/08/2025 PACTR Admin Adult: 19 Year-44 Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)