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.: PACTR202407592491170 Date of Approval: 29/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Vaginal misoprostol and intracervical foley catheter for cervical ripening: A comparative study at district hospitals in Abuja
Official scientific title Vaginal misoprostol and intracervical foley catheter for cervical ripening: A comparative study at district hospitals in Abuja
Brief summary describing the background and objectives of the trial BACKGROUND: Cervical ripening is the process of making an unfavourable cervix favourable for induction of labour. Induction of labour is a common obstetric intervention. This procedure is usually unsuccessful in the face of an unfavourable cervix, hence the need for cervical ripening prior to induction of labour. Foley catheter and misoprostol are both cost effective and readily available methods of cervical ripening. Studies have shown that unlike Foley catheter, misoprostol can ripen the cervix and also induce labour but with attendant adverse outcomes especially with high dose. Hence the need to compare the efficacy and safety of low dose misoprostol with foley catheter in cervical ripening prior to oxytocin induction of labour. AIM: the aim of this study is to compare the efficacy and safety of low dose misoprostol with foley’s catheter for cervical ripening. METHODOLOGY: This study is a prospective comparative study at Wuse and Asokoro district hospital, Abuja Nigeria. It will be conducted among 200 pregnant women at term. 100 in each of Foley’s catheter and misoprostol group. The expected outcome was a successful vaginal delivery following cervical ripening and induction of labour. The primary outcome measures were cervical ripening duration, cervical ripening to delivery interval, induction to delivery interval, Apgar scores, caesarean section rate, fresh still birth and uterine rupture. Secondary outcome measures were occurrence of obstetric complications including precipitate labour, primary post-partum haemorrhage, and fetal distress. RESULT: The generated data will be analysed statistically using Statistical package for social sciences (SPSS) version 2021. Mean and proportion will be compared using t-test and chi square test respectively. Significance will be considered on p value of <0.05. CONCLUSION: will be drawn from the findings. KEY WORDS: cervical ripening, foley catheter, misoprostol.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Labour and delivery
Purpose of the trial Cervical ripening
Anticipated trial start date 14/08/2023
Actual trial start date 14/08/2023
Anticipated date of last follow up 30/08/2024
Actual Last follow-up date 07/03/2024
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Misoprostol 25ug every 6 hours 24 hours maximum 25ug of misoprostol is inserted into the posterior fornix and Modified Bishops score assessed every 6 hours 100
Control Group intracervical Foley catheter filled with 50mls of sterile water 12 hours the intracervical 16G Foley catheter will be inserted into the cervix and filled with 50mls of sterile water and strapped to the thigh with plaster under tension 100 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All pregnant women at term(37weeks to 42 weeks) scheduled for induction of labour including those with medical conditions singleton pregnancies post date pre eclampsia pregnancy induced hypertension diabetes mellitus sickle cell disease previous uterine surgeries previous cesarean sections placenta previa oligohydramnios intra uterine fetal death rupture of membranes Adult: 19 Year-44 Year 15 Year(s) 49 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 27/03/2023 Federal capital territory Health research ethics Committee
Ethics Committee Address
Street address City Postal code Country
1, kapital Street, Area 11, Garki, Abuja Abuja 900247 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measures were cervical ripening duration, cervical ripening to delivery interval, induction to delivery interval, Apgar scores, caesarean section rate, fresh still birth and uterine rupture. The Bishops score is assessed at 0 hours, 6 hours and 12 hours. Apgar score and other parameters are assessed at delivery
Secondary Outcome Secondary outcome measures were occurrence of obstetric complications including precipitate labour, primary post-partum haemorrhage, and fetal distress. These parameters are assesed at delivery of the baby
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Asokoro district hospitl 11 Julius Nyerere crescent Abuja Abuja 900001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Personal savings 4 Daura close Area 1 Garki Abuja Abuja 900241 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Ibrahim Belinda Amina 4, Daura close, Area 1 Abuja 900241 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amina Ibrahim belindaibrahim30@yahoo.com +2348099451353 4, Daura close, Area 1
City Postal code Country Position/Affiliation
Abuja 900241 Nigeria senior regisrar
Role Name Email Phone Street address
Scientific Enquiries Francis Alu drfrankalu@yahoo.com +2348037206243 Abubakar avenue Efab
City Postal code Country Position/Affiliation
Abuja 900108 Nigeria chief consultant
Role Name Email Phone Street address
Public Enquiries Abdullahi Anate abdullahianate@gmail.com +2348097794064 Gwarinpa
City Postal code Country Position/Affiliation
Abuja 900108 Nigeria medical director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial after deidentifiacation Informed Consent Form,Study Protocol Immediately following publication. No end date Anyone who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not available 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