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.: PACTR202407560838827 Date of Approval: 29/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cervical ripening /Labour induction in postdate nulliparas; Comparative study of vaginal misoprostol versus vaginal misoprostol with rectal hyoscine-butylbromide
Official scientific title Cervical ripening /Labour induction in postdate nulliparas; Comparative study of vaginal misoprostol versus vaginal misoprostol with rectal hyoscine-butylbromide
Brief summary describing the background and objectives of the trial Cervical ripening is a method used to soften the cervix and cause effacement to increase the likelihood of a vaginal delivery. Induction of labour is the artificial initiation of uterine contractions after the age of foetal viability and before the spontaneous onset of labour to achieve vaginal delivery. The process of cervical ripening in nulliparous women can involve the use of upto three to four doses of 50mcg of misoprostol before a favourable Bishop's s ore is reached. In some cases a favourable Bishop's score may not be achieved leading to prolonged hospitalisation, failed induction, and increased caesarian delivery rate. Inhibitory impulses in the form of spasms, have been postulated to impair effacement and dilatation of the cervix. Antispasmodic agents such as hyoscine-bromide might overcome such spasms and lead to improvement in cervical ripping and favourability for induction, with resultant reduction of the induction-delivery interval and caesarean delivery rate. This study is to compare the outcome of the combination of vaginal misoprostol and rectal hysoscin butllbromide versus vagianl misprostol alone for cervical ripening/labour induction in postdate nuliparrous women
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CRLIPP
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Postdate pregnancy
Purpose of the trial Education /Training
Anticipated trial start date 25/08/2024
Actual trial start date 25/08/2024
Anticipated date of last follow up 25/02/2025
Actual Last follow-up date 25/04/2025
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Vaginal misoprostol with hyoscine butyl bromide 50mcg of vaginal misoprostol 20mg of rectal hyoscine butyl bromide (RectalHBB) 4 to 6hrs each At the start of the cervical ripening 50mcg of tabs, misoprostol will be inserted into the posterior vaginal fornix which will be followed immediately by the rectalHBB for the intervention group. While for the control group 50mcg of tabs misoprostol will be inserted into the posterior vaginal fornix which will be followed immediately by 10mg of tabs of semi-synthetic fatty acid glyceride as the placebo. After that, the Bishop score will be checked after 6hrs to assess the need for an additional dose of misoprostol and another dose of the trial drug (Vaginal misoprostol/placebo). A maximum of four doses of misoprostol and the trial drug HBB/placebo will be given dependeing on the Bishop's score assessed every six hours. The second, third or fourth dose of misoprostol or trial drug will not be given if a favourable Bishop's score of greater than or equal to seven is achieved only after the first dose was given. 35
Control Group Vaginal Misoprostol with hyoscine Butylbromide 50mcg of vaginal misoprostol 10mg tabs of semi-synthetic fatty acid glyceride 4 to 6hrs At the start of the cervical ripening 50mcg of tabs, misoprostol will be inserted into the posterior vaginal fornix followed immediately with 10mg tabs of semi-synthetic fatty acid glyceride as the placebo. After that, the Bishop score will be checked after 6hrs to assess the need for an additional dose of misoprostol and another dose of the placebo. A maximum of four doses of misoprostol and the placebo will be given dependeing on the Bishop's score assessed every six hours. The second, third or fourth dose of misoprostol and placebo will not be given if a favourable Bishop's score of greater than or equal to seven is achieved only after the first dose was given. 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Those who will give consent to the study. 2. Nulliparous pregnant women. 3. Postdate pregnancy. 4. Selected for cervical ripening and induction of labour. 5 Singleton pregnancy with vertex presentation. 1. maternal co-morbidities like hypertension, diabetes Mellitus, 2. Pregnancy complications like antepartum haemorrhage and severe pre-eclampsia Those allergic to hyoscine Those contraindicated to receive prostaglandins like asthma and glaucoma 5. Previous caesarian scar 6. Contraindication to vaginal delivery Malpresentation 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 08/02/2024 Rivers State University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
6 to 8 Harley Street. Old GRA. Port Harcourt Port Harcourt 500010 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cervical ripening as determined by changes in the Bishops score following insertion After every 6hrs. Outcome is monitored every six hours until a favourable Bishops score of greater than or equal to seven is achieved
Secondary Outcome Induction-delivery interval. Successful vaginal delivery or caesarian section rate. Need for supplemental oxytocin augmentation pre cervical ripening - 6hrs. Post cervical ripening - 6hrs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Rivers State University Teaching Hospital Port Harcourt no 6-8 Harley street old GRA . Port Harcourt 500010 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Augustus Otogwung No 1 Odi Street Old GRA, Port Harcourt Port Harcourt 500010 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Dr Augustus Otogwung No 1 Odi Street, Old GRA Port Harcourt Port Harcourt 500010 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Augustus Magnus OTOGWUNG augom70@yahoo.com +2348034679390 No 1 Odi Street. Old GRA
City Postal code Country Position/Affiliation
Port Harcourt 500010 Nigeria Senior Registrar Obstetrics and Gynaecology Rivers State University Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Peter Awoyesuku pawoyesuku@yahoo.co.uk +2348038997884 Behind Port harcourt primary School. Old GRA
City Postal code Country Position/Affiliation
Port Harcourt 500010 Nigeria Associate Professor of Obstetrics and Gynaecology
Role Name Email Phone Street address
Public Enquiries Auhustus Otogwung augom70@yahoo.com +2348034679390 No 1 Odi Street Old GRA
City Postal code Country Position/Affiliation
Port Harcourt 500010 Nigeria Senior Registrar Obstetrics and Gynaecology Rivers State University Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual data was collected during the trial after de-identification. other documents that will be available include the study protocol, statistical analysis plan, informed consent form, clinical study report, and analytical code. Data will be available immediately following publication and will remain available for up to 36months following publication Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 36 months Open Systemic reviews and meta analysis Principal investigator Qualifications
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