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.: PACTR202306488956692 Date of Approval: 05/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A comparison of the efficacy of concurrent use of intracervical foley catheter balloon and mifepristone to intracervical foley catheter alone for cervical ripening at term: a triple-blind randomized control trial
Official scientific title A comparison of the efficacy of concurrent use of intracervical foley catheter balloon and mifepristone to intracervical foley catheter alone for cervical ripening at term: a triple-blind randomized control trial
Brief summary describing the background and objectives of the trial Background: Induction of labour in the presence of an unripe cervix can lead to prolonged induction, chorioamnionitis, failed induction or increased caesarean section rate. Intracervical Foley catheter balloon is one of the methods of cervical ripening, however, its use often time requires need for repeat insertion or use of additional cervical ripening agents. Few recent studies have suggested that combination of Mifepristone and Foley catheter balloon improves the outcome of cervical ripening. However, available evidence is limited. Aim: To determine the efficacy of concurrent use of intracervical Foley catheter balloon insertion and oral Mifepristone versus intracervical Foley catheter balloon alone for cervical ripening in women with live foetus and unfavourable cervix scheduled for cervical ripening and induction of labour at term at Federal Medical Centre Asaba. Methodology: This will be a triple-blind randomized controlled trial among pregnant women at term scheduled for cervical ripening and induction of labour at Federal Medical Centre, Asaba. One hundred and twelve eligible and consented participants who meet the inclusion criteria will be randomized into two groups of concurrent Intracervical Foley catheter balloon and Placebo (group I) and concurrent Intracervical Foley catheter balloon and oral Mifepristone (group II) using computer randomizer application. Result: The raw data collected will be analyzed using the SPSS version 26 windows. Categorical data will be expressed as absolute numbers and percentages while continuous data will be expressed as mean ± standard deviation. Test of statistical hypothesis will be used for appropriate variables. Strengths and limitations: The study will be a triple-blind randomized controlled trial to minimize the effects of possible confounders and bias. Anticipated limitations are that the balloon may be expelled into the vaginam without the woman being aware of it as well as interobserver and intraobserver variabil
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 Treatment: Drugs
Anticipated trial start date 01/06/2022
Actual trial start date 29/06/2022
Anticipated date of last follow up 31/01/2023
Actual Last follow-up date 31/05/2023
Anticipated target sample size (number of participants) 112
Actual target sample size (number of participants) 112
Recruitment status Completed
Publication URL ANY ACCEPTED JOURNAL
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group THE EFFICACY OF CONCURRENT USE OF INTRACERVICAL FOLEY CATHETER BALLOON AND MIFEPRISTONE 200MG MIFEPRISTONE ONCE (SINGLE DOSE) CONCURRENT INTRACERVICAL FOLEY CATHETER BALLOON AND 200MG ORAL MIFEPRISTONE / CONCURRENT INTRACERVICAL FOLEY CATHETER BALLOON AND ORAL PLACEBO 56
Control Group EFFICACY OF INTRACERVICAL FOLEY CATHETRE BALLOON AND ORAL PLACEBO SINGLE DOSE ONCE DOSING AND INSERTION BALLOON CONCURRENT ADMINISTRATION OF INTRACERVICAL FOLEY CATHETER BALLOON AND ORAL PLACEBO 56 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All Consented pregnant women with the following: 1. Term pregnancy 2. Singleton foetus in cephalic presentation 3. Intact foetal membrane 4. Normal non stress test 5. Bishop Score of < 6 6. No contraindication to vaginal delivery 7. No known allergy or contraindication to Mifepristone. 1. Preterm pregnancy 2. Prolonged pregnancy (≥42 weeks gestation) 3. Prelabour rupture of foetal membrane 4. Previous caesarean section or major uterine surgery 5. Bishop score ≥ 6 at admission 6. Foetal malpresentation 7. Multiple pregnancy 8. Intrauterine foetal death, 9. Severe intrauterine growth restriction 10. Severe oligohydramnios 11. Major congenital anomalies 12. Allergy or contraindication to use of Mifepristone 13. Abnormal or non-reassuring non stress test 14. Contraindication to vaginal delivery Adult: 19 Year-44 Year 18 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 25/01/2022 HOSPITAL RESEARCH AND ETHIC COMMITTEE
Ethics Committee Address
Street address City Postal code Country
NNEBISI ROAD FEDERAL MEDICAL CENTRE ASABA, DELTA STATE ASABA 320104 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The Primary outcome measure will be proportion of women that will have favourable Bishop’s Score within 12 hours AT BALLOON EXPULSION, SPONTANOUES ONSET OF LABOUR AND AT 12 HOURS POST INSERTION
Secondary Outcome secondary outcomes will be balloon expulsion time, spontaneous onset of labour, need for oxytocin, vaginal delivery rate, cervical ripening-delivery interval, caesarean section rate and fetomaternal outcomes such as APGAR score < 7 at 1 minutes and 5 minutes, NICU admission and maternal drug side effects. AT BALLOON EXPULSION, SPONTANOEUS ONSET OF LABOUR ANT AT 12 HOURS POST INSERTION
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FEDERAL MEDICAL CENTRE ASABA NNEBISI ROAD, ASABA ASABA 320104 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
ESE ADIGBA ONODJOHWOYOVWE FEDERAL MEDICAL CENYTRE, ASABA ASABA 320104 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ESE ADIGBA ONODJOHWOYOVWE FEDERAL MEDICAL CENTRE ASABA 320104 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ESE ADIGBA ONODJOHWOYOVWE adigbaese@gmail.com 2348068115905 Federal Medical Centre
City Postal code Country Position/Affiliation
Asaba 320104 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Ese Adigba Onodjohwoyovwe adigbaese@gmail.com 2348068115905 Nnebisi road
City Postal code Country Position/Affiliation
Asaba 320104 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Peter Ndidi Ebeigbe peternebeigbe@gmail.com 2348035649146 Ugbowo road Benin
City Postal code Country Position/Affiliation
Benin 300283 Nigeria Professor and Chief consultant Delta State University Teaching Hospital Oghara
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual patient data (IPD) will be shared after deidentification of all data collected Informed Consent Form,Statistical Analysis Plan,Study Protocol February 2024 to May2024 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