Home » Trials » SLCTR/2013/030
Effectiveness of vaginal isosorbide mononitrate for cervical ripening in uncomplicated singleton pregnancies at 39 weeks gestation in an outpatient setting: A randomized controlled trial
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SLCTR Registration Number
SLCTR/2013/030
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Effectiveness of vaginal isosorbide mononitrate for cervical ripening in uncomplicated singleton pregnancies at 39 weeks gestation in an outpatient setting: A randomized controlled trial
Public Title of Trial
Effectiveness of vaginal isosorbide mononitrate for cervical ripening in uncomplicated singleton pregnancies at 39 weeks gestation in an outpatient setting: A randomized controlled trial
Disease or Health Condition(s) Studied
Induction of labour
Scientific Acronym
None
Public Acronym
None
Brief title
Use of vaginal ISMN in an out patient basis at term
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
What is the acceptability, effectiveness and safety of self administered vaginal isosorbide mononitrate (ISMN) in an outpatient setting to facilitate cervical ripening at term?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 0 (exploratory trials)
Intervention(s) planned
Consenting participants will be randomized into two arms.
The intervention arm will receive 5 doses of ISMN-SR 60mg to be self-administered vaginally at period of gestation (POG) of 39 weeks, 39 weeks & 2 days, 39 weeks & 4 days, 39 weeks & 6 days, 40 weeks & 1 day.
The control group will receive 5 doses of placebo (pyridoxine 10mg) to be self-administered vaginally at POG of 39 weeks, 39 weeks & 2 days, 39 weeks & 4 days, 39 weeks & 6 days, 40 weeks & 1 day.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Spontaneous Onset Labour (SOL) between 39 weeks and 40 weeks + 2 days |
[ POG of 40weeks + 2 days. ] |
|
2.
Mean Modified Bishops Score (MBS) at 40weeks + 2 days |
[ POG of 40weeks + 2 days. ] |
|
3.
Change in mean MBS between 39 weeks and 40 weeks + 2 days. |
[ POG of 40weeks + 2 days. ] |
Secondary outcome(s)
|
1.
Mean MBS at 40 weeks + 6 days. |
[ From 40 week + 2days to post delivery. ] |
|
2.
Requirement of Artificial Separation of Membranes and/or vaginal PGE2 and/or intra cervical Foley catheter at 40 weeks + 6 days. |
[ From 40 week + 2days to post delivery. ] |
|
3.
Requirement of induction of labour with amniotomy and intra venous oxytocin infusion at 41 weeks. |
[ From 40 week + 2days to post delivery. ] |
|
4.
Mean induction delivery interval. |
[ From 40 week + 2days to post delivery. ] |
|
5.
Total dose of oxytocin used. |
[ From 40 week + 2days to post delivery. ] |
|
6.
Mode of delivery |
[ From 40 week + 2days to post delivery. ] |
|
7.
Side effects (headache, pelvic pain, nausea/vomiting, hot flushes, dizziness and palpitations) |
[ From 40 week + 2days to post delivery. ] |
|
8.
Maternal satisfaction (using a questionnaire) |
[ From 40 week + 2days to post delivery. ] |
|
9.
Neonatal outcomes |
[ From the time of delivery up to discharge from the hospital ] |
Target number/sample size
200 (100 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2013-10-01
Anticipated end date
2014-06-30
Date of first enrollment
2013-01-10
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2013-08-27
Approval number
Not available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Professor Malik Goonewardene
Senior Senior Professor & Head of the department
Department of Obstetrics & Gynaecology, Faculty of Medicine,PO box 70, Galle.
091-2246878
091-2222314
malikg@eureka.lk
Contact Person for Public Queries
Professor Malik Goonewardene
Senior Professor & Head of the department
Department of Obstetrics & Gynaecology, Faculty of Medicine, PO box 70,Galle.
091-2246878
091-2222314
malikg@eureka.lk
Primary study sponsor/organization
University of Ruhuna
Department of Obstetrics & Gynaecology, Faculty of Medicine,PO box 70, Galle.
091-2246878
091-2222314
malikg@eureka.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
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
