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.: PACTR202101825071744 Date of Approval: 05/01/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A COMPARISON OF TWO DOSING REGIMENS OF MISOPROSTOL IN LABOUR INDUCTION: A RANDOMIZED CONTROLLED TRIAL.
Official scientific title A COMPARISON OF TWO DOSING REGIMENS OF MISOPROSTOL IN LABOUR INDUCTION: A RANDOMIZED CONTROLLED TRIAL.
Brief summary describing the background and objectives of the trial Misoprostol, a prostaglandin E1 analogue, is deemed more effective than the other conventional methods used for IOL. While lower-dose formulations of misoprostol are available in some parts of the world, in most low-resource settings including Ghana, it is available as a 200µg scored tablet which often is broken into pieces to provide approximate 50 and 100µg doses. Fifty micrograms of misoprostol administered vaginally in a four-hourly interval is a common IOL protocol in Sub-Saharan Africa and other low-resource settings. Sublingual administration of this regimen, although effective, has significantly more incidence of fetal distress, meconium-stained liquor, low Apgar score at the fifth-minute and neonatal admission into NICU. In the same sublingual administration, the rate of uterine tachysystole appears to decrease with increasing dosing interval.In practice, the sublingual regimen is easy to administer, more acceptable to women and remains the most practical option in certain clinical contexts such as PROM. Perhaps, increasing the dosing interval from four (4) to six (6) hours using the sublingual route will reduce the uterine tachysystole or hyperstimulation and yet maintain the effectiveness of the regimen. We compare the effectiveness and safety of 50μg of sublingual misoprostol administered six (6) hourly to the same dose administered vaginally in four (4) hourly intervals.
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 INDUCTION OF LABOUR IN LOW-RESOURCE SETTING
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2014
Actual trial start date 01/10/2014
Anticipated date of last follow up 31/12/2014
Actual Last follow-up date 31/12/2014
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants) 160
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 sublingual misoprostol 50ug of misoprostol administered every 6 hour interval until establishment of labour effectiveness and safety of 50μg of sublingual misoprostol administered six (6) hourly 80
Control Group vaginal misoprostol 50ug every 6 hours 50ug of misoprostol administered every 4 hours 80 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Live singleton gestations at 28 weeks and above with indication for IOL. Previous Caesarean section Previous Myomectomy Intrauterine fetal death Multiple gestation Breech presentation Known allergy to misoprostol Adult: 19 Year-44 Year 18 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 19/09/2014 CHRPE
Ethics Committee Address
Street address City Postal code Country
Room 7, Block J, School of Medical Science, Kwame Nkrumah University of Science and Technology, University Post Office, Kumasi Ghana Kumasi 2330 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome rate of vaginal delivery and uterine tachysystole/hyperstimulation n/a
Secondary Outcome Induction-delivery interval (IDI), need for oxytocin augmentation, passage of meconium, blood loss at vaginal delivery, 5-minute Apgar score <7, and neonatal intensive care unit (NICU) admissions were secondary outcome. n/a
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Komfo Anokye Teaching Hospital P.O.Box 1934 Kumasi Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Kwabena Amo Antwi Box 1934 Kumasi Kumasi Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kwabena Amo Antwi P.O. Box 1934 Kumasi Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
Prof Baafuor Kofi Opoku Faculty of Obstetrics and Gynaecology, School of Medicine and Dentistry, Kwame Nkrumah University of Science And Technology Kumasi 233 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kwabena Amo Antwi amoantwikwabena@yahoo.com +233206300633 P.O.Box 1937
City Postal code Country Position/Affiliation
Kumasi 2330 Ghana Senior Specialist Obstetrician Gynaecologist
Role Name Email Phone Street address
Public Enquiries Ramatu Agambire ragambire@yahoo.com +233244582016 Dept of Nursing, Faculty of Health Science, Garden City University College
City Postal code Country Position/Affiliation
Kumasi 2330 Ghana Lecturer
Role Name Email Phone Street address
Scientific Enquiries Edward Tieru Dassah edidassah@yahoo.com +233206300657 Dept Of Obstetrics and Gynaecology, Komfo Anokye Teaching Hospital
City Postal code Country Position/Affiliation
Kumasi 2330 Ghana Senior Specialist Obstetrician Gynaecologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes For data protection the data set is not publicly accessible. However, data can be accessed from the primary or corresponding author upon reasonable request with a signature of data privacy form. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data are available indefinitely at amoantwikwabena@yahoo.com open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 21/10/2020
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