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.: PACTR201707002378458 Date of Registration: 26/06/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A randomized control trial of two regimens of oral misoprostol solution in induction of labour
Official scientific title Hourly titrated oral misoprostol solution and 2 hourly static oral misoprostol solution in induction of labour: A randomized controlled trial
Brief summary describing the background and objectives of the trial The dosage and route of administration of misoprostol have been evaluated in some studies in attempts to determine the appropriate dosing and best route that are compatible with efficacy and safety. In 2012, the International Federation of Gynecology and Obstetrics (FIGO) recommended an oral dose of 25mcg misoprostol solution every 2 hours to induce labor using the 2011 World Health Organization (WHO) recommendation for induction of labour. A 2014 Cochrane review of oral misoprostol for labor induction supported the use of oral regimens over vaginal regimen and that the dose of oral misoprostol should be 20 - 25 mcg given every 2 hours. Few studies have also examined the frequency of administration of misoprostol in the induction of labour. A randomized controlled trial (RCT) by Rouzi et al demonstrated that hourly titrated oral misoprostol can provide an efficacious and safe substitute for the expensive dinoprostone vaginal insert. In another RCT where the hourly titrated oral misoprostol was compared with the 2hourly oral dose of 25µg misoprostol recommended by FIGO, the regimen of static-dose misoprostol solution every 2 hours has similar efficacy as the hourly titrated dose regimen but with fewer side effects and complications. In addition, the static-dose every 2 hours regimen is simpler and would allow more widespread use of oral misoprostol for labor induction. This is the only known RCT to have done this comparison and more trials will be need for meta-analysis or Cochrane review on these regimens. Therefore, this study compared the efficacy and safety of the hourly titrated and two hourly static oral misoprostol solution regimens in the induction of labour at Ekiti State University Teaching Hospital, Ado-Ekiti and its applicability in our setting.
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 Hourly titrated oral misoprostol solution and 2 hourly static oral misoprostol solution
Anticipated trial start date 01/04/2017
Actual trial start date 01/05/2017
Anticipated date of last follow up 31/10/2017
Actual Last follow-up date 30/11/2017
Anticipated target sample size (number of participants) 136
Actual target sample size (number of participants) 150
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a random table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hourly titrated oral misoprostol solution 20mcg - 60mcg 24 hours induction of labour 75
Control Group 2 hourly static oral misoprostol solution 25mcg 24 hours Induction of labour 75 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women with live singleton fetuses with cephalic presentation, intact membranes, reactive non-stress test and unfavorable cervices (Bishop¿s score <6) scheduled to undergo induction of labor at term. Women with pregnancies <37 weeks gestation, intrauterine fetal death, multiple gestations, previous uterine surgery, prelabour rupture of fetal membranes, abnormal non-stress test and any contraindication to vaginal delivery were excluded. Also, women whose parity was greater than 4, who did not give their consent or have prenatal care in this centre were excluded. 20 Year(s) 45 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 04/03/2017 Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
Ekiti State University Teaching Hospital Ado-Ekiti 36001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Rate of successful induction (vaginal delivery within 24 hours) Within 24 hours
Secondary Outcome induction-delivery interval, oxytocin requirements, caesarean delivery rate, Apgar scores, admission into special baby care unit (SCBU), and occurrence of complications of IOL like fetal heart rate abnormalities, uterine rupture etc Within 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ekiti State University Teaching Hospital Adebayo Street Ado-Ekiti 36001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Aduloju Olusola Peter Adebayo Street Ado-Ekiti 36001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ekiti State University Teaching Hospital Adebayo Street, Iworoko road Ado-Ekiti 36001 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Aduloju Tolulpoe Adebayo Street Ado-Ekiti 36001 Nigeria
Ipinnimo Oluwadare Martins Adebayo Street Ado-Ekiti 36001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Peter Aduloju peter.aduloju@yahoo.com 2348033900908 Adebayo Street
City Postal code Country Position/Affiliation
Ekiti State 36001 Nigeria Senior Lecturer/ Ekiti State University
Role Name Email Phone Street address
Public Enquiries Tolulope Aduloju toluy2k200@yahoo.com 2348037254033 Adebayo Street
City Postal code Country Position/Affiliation
Ado-Ekiti 36001 Nigeria Research Nurse/ Social worker
Role Name Email Phone Street address
Scientific Enquiries Oluwadare Ipinnimo ipinnimodare@yahoo.com 2348033748593 Adebayo Street
City Postal code Country Position/Affiliation
Ekiti State 36001 Nigeria Senior Resident, OBGYN
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information