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.: PACTR202404666076601 Date of Approval: 02/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Transcervical Foley Catheter with a 50-mL versus 80-mL Single Balloon Volume for Cervical Ripening in Late and Postterm Nulliparous Women: A Single Center Randomized Clinical Trial.
Official scientific title Transcervical Foley Catheter with a 50-mL versus 80-mL Single Balloon Volume for Cervical Ripening in Late and Postterm Nulliparous Women: A Single Center Randomized Clinical Trial.
Brief summary describing the background and objectives of the trial gVariations in single-balloon FC inflation volumes during clinical practice potentially influence the efficacy of cervical ripening procedures. There is a need for research on the efficacy of an 80 ml single-balloon catheter for cervical ripening, with particular consideration of parity status. This clinical trial was performed to assist in providing greater clinical clarity. The objective of the study was to compare the effectiveness of a transcervical Foley catheter (FC) with that of a 50-mL or 80-mL single balloon volume for preinduction cervical ripening in late and postterm nulliparous women.
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 26/08/2021
Actual trial start date 26/08/2021
Anticipated date of last follow up 15/08/2022
Actual Last follow-up date 25/08/2022
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
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 Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group 50 mL of transcervical Foley Catheter balloon volume 24 hours 50 mL of transcervical Foley Catheter balloon volume was placed in 60 participants for 24 hours 60 Dose Comparison
Experimental Group 80 mL Foley catheter 24 hours 80 mL of transcervical Foley Catheter balloon volume was placed in 60 participants for 24 hours 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Nulliparous women (no prior pregnancy > 20 weeks gestation) Aged ≥ 18 years. Gestational age of 41+0 weeks or beyond, based on the last known monthly period. Carrying a single live intrauterine pregnancy in cephalic presentation, with intact amniotic membranes. Demonstrating a reassuring fetal heart rate pattern on cardiotocograph (CTG) tracing. Nonsignificant contractions (two or more in 10 minutes). Unfavourable cervix (Bishop score < 6). History of antepartum bleeding. Use of another ripening agent before FC placement. Active lower urinary tract infections. known or suspected latex allergy. Placenta previa. Significant fetal anomalies. Contraindications to vaginal delivery. Known or newly diagnosed human immunodeficiency virus (HIV) infection. Adult: 19 Year-44 Year 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 26/08/2021 Moi University and Moi Teaching and Referral Hospital IREC
Ethics Committee Address
Street address City Postal code Country
Nandi road Eldoret 30100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of women who achieved a Bishop score ≥ 6 at 24 hours after catheter placement. 24 hours post intervention
Secondary Outcome Proportion of vaginal deliveries within 24 hours of induction. 24 hours post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Moi Teaching and Referral Hospital Nandi Road Kapsoya Ainabkoi. Eldoret 30100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Franklin Okumu MTRH, Nandi Road. Eldoret 30100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Franklin Okumu MTRH, Nandi Road Eldoret 30100 Kenya Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Franklin Okumu franklinokumu2@gmail.com 00254710308577 MTRH, Nandi Road
City Postal code Country Position/Affiliation
Eldoret Kenya Registrar Reproductive Health
Role Name Email Phone Street address
Public Enquiries Franklin Okumu franklinokumu2@gmail.com 00254710308577 MTRH, Nandi Road
City Postal code Country Position/Affiliation
Eldoret Kenya Registrar Reproductive Health
Role Name Email Phone Street address
Scientific Enquiries Kimbley Omwodo kimbleyasaso@yahoo.com 00254705557929 MRTH, Nandi Road
City Postal code Country Position/Affiliation
Eldoret Kenya Registrar Reproductive Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes This study is committed to promoting transparency and open science by sharing de-identified individual participant data (IPD) in accordance with the World Health Organization's guidelines. The following outlines our IPD sharing plan: Data Sharing Intent: We intend to share de-identified IPD collected during this trial, including demographic information, baseline characteristics, outcome measures, and adverse events. Data Availability: The IPD will be available upon request following the publication of the primary study results and ending five years after the data collection is complete. Data Request Process: Researchers wishing to access the IPD must submit a detailed proposal outlining the objectives, methodology, and intended use of the data. Proposals will be evaluated by an independent data access committee for scientific rigor and ethical considerations. Data Format and Access: Approved researchers will be provided access to the de-identified IPD in a secure, password-protected environment. Data will be shared in a commonly used format, such as CSV or Excel, with accompanying documentation to ensure proper understanding and use. Data Privacy and Ethics: All shared IPD will be de-identified to protect participant privacy. Researchers accessing the data will be required to sign a data use agreement, committing to using the data only for the approved purposes and maintaining confidentiality. Data Use and Publication: Researchers are encouraged to collaborate with the original study team and are expected to acknowledge the source of the data in any publications resulting from the use of the IPD. Informed Consent Form 10 years Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 30/03/2024 08/10/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 30/03/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information