Home » Trials » SLCTR/2008/002
A randomised controlled trial comparing intra-vaginal Misoprostol with trans-cervical Foley catheter for the pre-induction cervical ripening
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SLCTR Registration Number
SLCTR/2008/002
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A randomised controlled trial comparing intra-vaginal Misoprostol with trans-cervical Foley catheter for the pre-induction cervical ripening
Public Title of Trial
To compare the effectiveness of trans-cervical foley catheter and intravaginal Misoprostol in making the uterine cervix more favourable for induction of labour
Disease or Health Condition(s) Studied
Effectiveness of trans-cervical foley catheter and intra-vaginal Misoprotol for pre induction cervical ripening
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC/07/094 (Ethics Review Committee of the Faculty of Medicine, University of Colombo)
What is the research question being addressed?
Is intra-vaginal misoprostol a more effective pre induction cervical ripening agent compared to trans-cervical foley catheter ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Other
Study Phase
Not Available
Intervention(s) planned
A patient who will be decided to undergo labour and who meet the criteria for the study will be randomized to receive either trans-cervical foley catheters or intra-vaginal misoprostol as the pre- induction cervical ripening agent.
Inclusion criteria
Consented women with singleton gestation in vertex presentation at greater than 28 weeks gestation with Bishop’s score less than 6
Exclusion criteria
•Rupture of membranes antepartum bleeding •active genital herpes infection •fetal death •placenta praevia •previous induction or pre-induction agent during the pregnancy, and known allergy to misoprostol •Women with history of cesarean deliveries will not be excluded
Primary outcome(s)
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1.
Time to vaginal delivery or vaginal delivery rates within a specified time Operative delivery rates (caesarean section and instrumental vaginal delivery) •Length of labour/incidence of prolonged labour •Measures of effectiveness (oxytocin augmentation rates •epidural usage •cervix unfavorable/unchanged at 12–24 hours) •Serious maternal morbidity or death •Other adverse outcomes (e.g. uterine hypercontractility •Postpartum haemorrhage •Maternal adverse effects) •Measures of maternal satisfaction •Serious neonatal morbidity or perinatal death •Other adverse perinatal outcomes (meconium-stained liquor •Five-minute apgar score of less than seven •Neonatal intensive care unit admission) |
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Secondary outcome(s)
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1.
None |
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Target number/sample size
100 (50 per group)
Countries of recruitment
Sri Lanka
Anticipated start date
2008-01-01
Anticipated end date
2008-06-30
Date of first enrollment
Date of study completion
Recruitment status
Suspended
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2008-01-17
Approval number
EC/07/094
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. T.D. Dias
Senior Registrar
Department of Obstetrics & Gynaecology,Faculty of Medicine, University of Colombo
0773051142
thiran_dias@yahoo.com
Contact Person for Public Queries
Dr. K.M.D.J. Rodrigo
Research Associate
Department of Obstetrics & Gynaecology,Faculty of Medicine,University of Colombo
0776519518
damith_rodrigo@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Avavilable
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
