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.: PACTR201911698481916 Date of Approval: 19/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Cervical ripening for induction of labour using 30ml versus 60ml Foley's balloon catheter in Ebonyi State, Nigeria: A randomized controlled trial
Official scientific title Cervical ripening for induction of labour using 30ml versus 60ml Foley's balloon catheter in Ebonyi State, Nigeria: A randomized controlled trial
Brief summary describing the background and objectives of the trial Background: The ripeness of the cervix is an important prerequisite to a successful labour induction. The use of extra-amniotic Foley catheter is one of the mechanical methods of cervical ripening and has been proven to be effective and safe. There is controversy, however, on difference in efficacy of this method when different volumes of water are used to inflate the catheter balloon. The ideal volume of water to use for inflation of the catheter balloon for optimal efficacy and patent’s satisfaction has not been ascertained. Objectives: To compare the difference in efficacy between 30ml and 60ml of water for inflation of Foley catheter balloon when used for cervical ripening during induction of labour.
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 10/07/2019
Actual trial start date 01/08/2019
Anticipated date of last follow up 31/01/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 260
Actual target sample size (number of participants)
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 Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group A Foleys catheter to be inflated with 30ml of sterile water for cervical ripening 30 ml 12 Hours Group A will have cervical ripening using extra-amniotic Foley's catheter inflated with 30 ml of sterile water, 130 Dose Comparison
Experimental Group Group B Foleys catheter to beinflated with 60ml of sterile water for cervical ripening 60 ml 12 Hours Group B will have cervical ripening using extra-amniotic Foley's catheter inflated with 60 ml of sterile water. 130
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Term pregnancy (37 - 41+6 weeks’ gestational age) singleton fetus vertex presenting fetus intact fetal membranes unfavorable cervix selected for cervical ripening with extra-amniotic Foley’s catheter. • Ruptured fetal membranes • Previous uterine surgery • Low lying placenta • Multiple pregnancy • HIV positive mothers • Malpresenting fetuses • Presence of painful, regular uterine contractions • Patients that opted for use of epidural analgesia in labour • Parturients presenting with favourable cervix • Fetal anomaly • Patients who do not consent to the study. Adult: 19 Year-44 Year 19 Year(s) 44 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 10/07/2019 Human Research and Ethics Committee of Alex Ekwueme Federal University Teaching Hospital Abakaliki
Ethics Committee Address
Street address City Postal code Country
FMC Hospital road, Abakaliki Abakaliki 480231 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Time taken to achieve favorable Bishop Score 2. Time taken for patient to attain active phase parameter 3. Induction-delivery interval Before induction of labour, in labour and after delivery
Secondary Outcome 1. Mode of delivery (vaginal or caesarean section) 2. Maternal complications ( cervical laceration, postpartum hemorrhage) 3. Maternal satisfaction 4. Fetal outcome ( Apgar score in 1st and 5th minutes, neonatal intensive care admission, seizures, stillbirth or neonatal death) 5. Number of times the procedure was done before favorable cervix was attained After delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi state Nigeria FMC Hospital Road, Udensi Abakaliki, Ebonyi State. Abakaliki 480231 Nigeria
Mile 4 Hospital Abakaliki Enugu- Abakaliki Road, Azuiyi Udene Ishieke Abakaliki 480211 Nigeria
Mater Misericordiae Hospital Afikpo Hospital Road Afikpo Afikpo Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nnabugwu Adiele FMC Hospital road, Abakaliki Abakaliki 480231 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NNABUGWU ALFRED ADIELE Doctors Quarters Alex Ekwueme Federal University Teaching Hospital, Abakaliki Abakaliki 480231 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr LUcky O. Lawani FMC Hospital road Abakaliki 480231 Nigeria
Dr Christian C. Mgbafulu FMC Hospital road Abakaliki 480231 Nigeria
Dr Chidebe C. Anikwe FMC Hospital road Abakaliki 480231 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nnabugwu Adiele nadiele2001@gmail.com +2348039397529 FMC Hospital road
City Postal code Country Position/Affiliation
Abakaliki 480231 Nigeria Principal investogator
Role Name Email Phone Street address
Public Enquiries Chidebe Anikwe drchideanikwechristian@gmail.com +2348064165965 FMC Hospital road
City Postal code Country Position/Affiliation
Abakaliki 480231 Nigeria Public Enquires
Role Name Email Phone Street address
Scientific Enquiries Lucky Lawani lawkins2020@gmail.com +2348036691209 FMC Hospital road
City Postal code Country Position/Affiliation
Abakaliki 480231 Nigeria Scientific Enquires
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Information will recorded in details in a proforma. This will contain all the necessary events occurring during the research.This will be reported according to the CONSORT guideline. The data will be will preserved in save place and i am willing to share available data anytime this is required of me. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 5 years Open access (unrestricted)
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