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.: PACTR202311571442229 Date of Approval: 10/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Outpatient versus inpatient cervical ripening with Foley catheter in pregnant women at term at the University of Maiduguri teaching hospital.
Official scientific title Outpatient versus inpatient cervical ripening with Foley catheter in pregnant women at term at the University of Maiduguri teaching hospital. A randomised controlled trial
Brief summary describing the background and objectives of the trial Induction of labour in the setting of unripe cervix is associated with increased induction failure, high caesarean rate and increase risk of chorio-amnionitis. Pre-induction cervical ripening with balloon Foley catheter has been shown to have equal efficacy and better safety margin compared to prostaglandins. Balloon Foley catheter is an effective agent for cervical ripening. Thus, the intervention can be carried out in an outpatient setting. The objective of the study is to determine and compare the effectiveness, safety and maternal satisfaction of outpatient versus inpatient cervical ripening with balloon Foley catheter
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 03/05/2023
Actual trial start date 03/05/2023
Anticipated date of last follow up 03/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 166
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
Crossover: all participants receive all interventions in different sequence 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 Outpatient cervical ripening with Foley catheter Single balloon Foley catheter inflated with 60mls volume 12 hours transcervical single balloon foley catheter would be inserted and the balloon is inflated with 60mls of sterile water for injection. patient would be counsel on danger signs and sign of labour and the need to present to labour ward if there is such. otherwise they should present to labour ward 0600HR for catheter removal and induction of labour 83
Control Group Inpatient cervical ripening with Foley catheter Single balloon foley catheter inflated with 60mls of sterile water for injection 12 hours after randomising to inpatient, transcervical foley catheter would be inserted and the balloon would be inflated with 60mls of sterile water for injection. patient would be on admission and will be reviewed if there is labour or development of danger signs otherwise until 12 hours the catheter will be removed if not fell spontaneously and induction would be commenced. 83 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) All booked and stable pregnant women who are planned for induction of labour at term with singleton pregnancy presenting cephalic with unfavorable cervix (Bishop Score of ≤5). 2) Patients that are informed, counseled, and consented to participate in the study. 1) Bishop score ≥6 2) Contraindication to vaginal delivery 3) Antepartum hemorrhage. 4) Ruptured membrane 5) Multiple pregnancy 6) Patients with intrauterine fetal death, HIV, active hepatitis B infection 7) Previous cervical injury 8) Prematurity 9) Non vertex presentation 10) Medical disorders (excluding Controlled DM, mild hypertension) 11) non consent 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 20/02/2023 University of Maiduguri Teaching Hospital ethical committee
Ethics Committee Address
Street address City Postal code Country
PMB 1414 Bama Road, Maiduguri, Borno State Maiduguri 60004 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean change in Bishop score, clinical chorioamnionitis, overall maternal satisfaction pre induction and at the time of second presentation to labour
Secondary Outcome induction to delivery interval, delivery within 24 hours, total duration of hospital stay, fetal heart rate abnormalities, caesarean rate, admission in SCBU, birth asphyxia, neonatal death, intra and postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Maiduguri teaching hospital PMB 1414 Bama road, Maiduguri Borno State, Nigeria. Maiduguri Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Aliyu Sahabo Gurin Jiddari Polo off Goni Kime Mosque Maiduguri, Borno State Maiduguri Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Aliyu Sahabo Gurin Jiddari Polo off Goni Kime Mosque Maiduguri, Borno State Maiduguri Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aliyu Sahabo draliyugurin@gmail.com +2347033305890 Jiddari Polo off Goni Kime Mosque Maiduguri, Borno State.
City Postal code Country Position/Affiliation
Maiduguri Nigeria Senior registrar
Role Name Email Phone Street address
Public Enquiries Aliyu Sahabo draliyugurin@gmail.com +2347033305890 Jiddari Polo off Goni Kime Mosque Maiduguri, Borno State.
City Postal code Country Position/Affiliation
Maiduguri Nigeria Senior registrar
Role Name Email Phone Street address
Scientific Enquiries Babagana Bako babaganabako@gmail.com +2348035997255 New GRA Maiduguri, Borno State
City Postal code Country Position/Affiliation
Maiduguri Nigeria Prof. Obstetrician and Gynaecologist. University Of Maiduguri Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the data that would be shared is for individual participant data that underlie the results obtained from the trial. the data will be made available immediately after publication. the data would be available for any researcher who wishes to access it. the data could be use for individual participant meta-analysis. the link to access for the data would be made available after publication.. Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 year open access
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