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.: PACTR202512871635509 Date of Registration: 15/12/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title OSSAI'S TRIAL
Official scientific title A comparison of the effect of intracervical Foley catheter balloon volumes 30ml versus 60ml on cervical ripening among pregnant women planned for induction of labour at term: a triple blind randomized controlled trial.
Brief summary describing the background and objectives of the trial Induction of labour and the demand for a safe method for induction of labour will remain dominant issues in obstetrics practice for a long time. Cervical ripening is one of the most important determinants of a successful labour induction process. The placement of a transcervical Foley catheter is a safe and very effective method for cervical ripening. Studies done to determine the effect of using different inflatable catheter balloon volumes on the success rate of achieving pre-induction cervical ripening have yielded mixed results. Aim: To determine and compare the effect of the use of different Foley catheter balloon volumes (30 and 60-mL) on cervical ripening at the 12th hour post insertion or spontaneous expulsion, among pregnant women at term undergoing cervical ripening for labour induction using the 30 ml balloon volume as control. Study Design: A Triple blind randomized controlled trial Research Methods: This study will be conducted in the department of Obstetrics and Gynaecology, of the Federal Medical Centre Asaba, Delta State. A total of 192 consenting pregnant women admitted for induction of labour at term with a singleton gestation will be recruited. They will be randomly assigned into 2 groups (group A and B) for cervical ripening using a single balloon 18-French Foley catheter which will be inflated either with 30-mL or 60-mL of sterile saline and will be retained for a maximum duration of 12 hours. Randomization will be by simple random technique using a research randomizer application software. The sample size will be estimated by assuming a 5% type I error and 90% power (α=0.05) to detect a 20% difference between the study arms. The primary outcome measure will be the proportion of women that achieve favourable cervix at the 12th hour post Foley catheter balloon insertion or spontaneous expulsion. The secondary outcome measures will include; Foley catheter insertion to expulsion interval, Induction to delivery interval, change in bishop score, catheter balloon rupture, iatrogenic membrane rupture, need for additional ripening agent, Vaginal delivery rate, cesarean section rate and participants’ satisfaction with the use of the various inflatable catheter balloon volumes among pregnant women at term who had their Foley catheter balloon inflated to 30 and 60ml respectively for pre-induction cervical ripening. Data will be collated and analyzed with Statistical Product and Service Solutions (SPSS) version 26.0 (SPSS Inc., Chicago, USA). An intention to treat method of analysis will be employed. Comparison of study participants’ baseline characteristics, primary and secondary outcome measures will be conducted using the Chi-Square tests for categorical variables, and the Student’s t-test for continuous variables. Statistical significance was set as p = 0.05. The results will be displayed using flow charts and tables.
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: Devices
Anticipated trial start date 17/01/2024
Actual trial start date
Anticipated date of last follow up 17/06/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 192
Actual target sample size (number of participants)
Recruitment status Not yet 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 Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group 30mL Foley catheter balloon maximum of 12hours for participants who met the criteria for cervical ripening and induction of labour and has been allocated to the 30mL study arm(control), intracervical extra-amniotic Foley catheter will be passed and then inflated with 30mL of normal saline 96 Historical
Experimental Group 60mL Foley catheter balloon maximum of 12hours for participants who met the criteria for cervical ripening and induction of labour at term and has been allocated to the 60mL study arm(experimental arm), an intracervical extra-amniotic Foley catheter will be passed and then inflated with 60mls of normal saline. 96
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Singleton pregnancy • Cephalic presentation • Intact fetal membrane • Gestational age ≥37weeks • Bishop score ≤ 5 • Reactive non-stress test • All consenting patients • Multiple pregnancy • Abnormal fetal presentation • Ruptured fetal membrane • Gestational age < 37 weeks • Intra-uterine fetal death • Previous extensive uterine surgery • Contra-indication to vaginal delivery • Non-reactive non-stress test(NST) • Bishop score ≥6 • Patient’s refusal • HIV positive status • Fetal structural anomaly. 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) 50 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 25/09/2023 Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Federal Medical Centre, Asaba Asaba 320242 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure will be the proportion of women that achieve favourable cervix at the 12th hour post Foley catheter balloon insertion or spontaneous expulsion 12th hour post Foley catheter insertion or spontaneous expulsion
Secondary Outcome The secondary outcome measures will include; Foley catheter insertion to expulsion interval, Induction to delivery interval, catheter balloon rupture, iatrogenic membrane rupture, need for additional ripening agent, Vaginal delivery rate, cesarean section rate and participants’ satisfaction with the use of the various inflatable catheter balloon volumes among pregnant women at term, who had their Foley catheter balloon inflated to 30 and 60ml respectively for pre-induction cervical ripening at term 12th hour post Foley catheter insertion or spontaneous expulsion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical centre Asaba Federal Medical Centre, Nnebisi Road Asaba Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
OSSAI CHUKWUMA ANTHONY Department of obstetrics and gynaecology, federal medical centre, Nnebisi Road Asaba Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor OSSAI CHUKWUMA ANTHONY Department of Obstetrics and Gynaecology, Federal Medical centre, Nnebisi Road Asaba Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof. Peter Ndidi Ebeigbe Delta State University Teaching Hospital, Oghara Oghara Delta state Nigeria
Dr Ufuoma Eyeregba Federal Medical Centre, Asaba Asaba Delta State Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator CHUKWUMA ANTHONY chuksanexcels@gmail.com +2347030082557 Department of Obstetrics and Gynaecology, Fedreal Medical Centre, Nnebisi Road
City Postal code Country Position/Affiliation
Asaba Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries UFUOMA EYEREGBA itsufuoma2000@yahoo.com +2348038794901 Federal Medical Centre, Nnebisi Road
City Postal code Country Position/Affiliation
Asaba Nigeria Consultant Obstetrician
Role Name Email Phone Street address
Scientific Enquiries PETER EBEIGBE peternebeigbe@gmail.com +2348035649146 Federal Medical Centre, Nnebisi Road
City Postal code Country Position/Affiliation
Asaba Nigeria Visiting Consultant Obstetrician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant Data (IPD) summary results of all the individual participant data collected during the trial after deidentification Informed Consent Form,Study Protocol July 2024 - December 2024 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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 01/12/2025 Initial title was mistakenly entered in CAPS A COMPARISON OF THE EFFECT OF INTRACERVICAL FOLEY CATHETER BALLOON VOLUMES 30MLS VERSUS 60MLS ON CERVICAL RIPENING IN PREGNANT WOMEN PLANNED FOR INDUCTION OF LABOUR AT TERM: A TRIPLE-BLIND RANDOMIZED CONTROLLED TRIAL. A comparison of the effect of intracervical Foley catheter balloon volumes 30ml versus 60ml on cervical ripening among pregnant women planned for induction of labour at term: a triple blind randomized controlled trial.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 01/12/2025 Nil 22 Jan 2024
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 08/12/2025 Age ranges not completely ticked Adult: 19 Year-44 Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 01/12/2025 There was misspelling in the ethical approval TRUE, Research and Ethics Committee, Federal Medical Centre, Asaba, Asaba, 320242, Nigeria, , 25 Sep 2023, +2348136450385, info@fmcasaba.org, 27154_28163_4737.pdf TRUE, Research and Ethics Committee, Federal Medical Centre, Asaba, Asaba, 320242, Nigeria, , 25 Sep 2023, +2348136450385, info@fmcasaba.org, 27154_28163_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 08/12/2025 There was misspelling in the ethical approval TRUE, Research and Ethics Committee, Federal Medical Centre, Asaba, Asaba, 320242, Nigeria, , 25 Sep 2023, +2348136450385, info@fmcasaba.org, 27154_28163_4737.pdf TRUE, Research and Ethics Committee, Federal Medical Centre, Asaba, Asaba, 320242, Nigeria, , 25 Sep 2023, +2348136450385, info@fmcasaba.org, 27154_28163_4737.pdf