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.: PACTR201312000680425 Date of Approval: 17/10/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A randomised controlled trial comparing combined misoprostol-foley's catheter with foley's catheter and low dose misoprostol for cervical ripening.
Official scientific title A randomised controlled trial comparing combined misoprostol-foley's catheter with foley's catheter and low dose misoprostol for cervical ripening
Brief summary describing the background and objectives of the trial To compare the efficacy of misoprostol-foley's catheter combination to foley's catheter or misoprostol alone for pre-induction cervical ripening
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Induction of labour,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/11/2013
Actual trial start date 01/09/2014
Anticipated date of last follow up 31/01/2014
Actual Last follow-up date 31/01/2014
Anticipated target sample size (number of participants) 210
Actual target sample size (number of participants) 210
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Misoprostol-Foley's Catheter group Patients receives 25mcg of vaginal misoprostol and transcervical foley's catheter passed at the same time. The bishop's score is accessed in 12 hours. 70
Control Group Misoprostol alone group 25mcg 6hourly, maximum of 3 doses Patient receives 25mcg of vaginal misoprostol for cervical ripening every 6 hours till a maximum of 3 doses. Cervix is assessed every 6 hours to determine if ripe 70
Control Group Foley's catheter alone Transcervical foley's catheter is passed and bishop's score of the cervix assessed 12 hours later to determine if ripe 70
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Singleton pregnancies for induction of labour for various obstetrics reasons. 1.Previous caesarean section patients 2.Previous history of anaphylactic reaction to misoprostol 3.History of asthmatic attack 4.History of prelabour rupture of membrane 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 10/10/2013 Ekiti State University Teaching Hospital Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
Iworoko road Ado-Ekiti 10001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time interval it takes for ripening of the cervix to be acheived 6hourly 12 hourly
Secondary Outcome Labour and Neonatal outcomes/complications After delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ekiti State University Teaching Hospital, Iworoko road Ado-Ekiti 10001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Adanikin Abiodun
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ekiti State University Teaching Hospital Iworoko road Ado-Ekiti 10001 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr Aduloju O.P. Ekiti State University Teaching Hospital, Ado-Ekiti 10001 Nigeria
Dr Akintayo A.A Ekiti State University Teaching Hospital, Ado-Ekiti 10001 Nigeria
Dr Adanikin A.I Ekiti State University Teaching Hospital, Ado-Ekiti 10001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olusola Peter Aduloju peter.aduloju@yahoo.com 2348033900908
City Postal code Country Position/Affiliation
Ado-Ekiti Nigeria Ekiti State University Teaching Hospital
Role Name Email Phone Street address
Principal Investigator Olusola Peter Aduloju peter.aduloju@yahoo.com 2348033900908 Ule Iya elepo, Oke Bola
City Postal code Country Position/Affiliation
Ado-Ekiti 10001 Nigeria Ekiti State University Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Abiodun Idowu Adanikin adanikinbiodun@yahoo.com 2348034252126 Block1, Shelter view estate
City Postal code Country Position/Affiliation
Ado-Ekiti 10001 Nigeria Ekiti State University Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Abiodun Idowu Adanikin adanikinbiodun@yahoo.com 2348034252126
City Postal code Country Position/Affiliation
Ado-Ekiti Nigeria Ekiti State University Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Akinyemi Akinsoji Akintayo akinyemiakintayo@yahoo.co.uk 2348033767542 5, Nova junction, Bashiri
City Postal code Country Position/Affiliation
Ado-Ekiti 10001 Nigeria Ekiti State University Teaching Hospital
REPORTING
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