Home » Trials » SLCTR/2010/009
Efficacy of two different treatment regimens of vaginal nitric oxide donor (Isosorbide mononitrate) used for pre-induction cervical ripening: A randomized controlled trial
-
SLCTR Registration Number
SLCTR/2010/009
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Efficacy of two different treatment regimens of vaginal nitric oxide donor (Isosorbide mononitrate) used for pre-induction cervical ripening: A randomized controlled trial
Public Title of Trial
Vaginal isosorbide mononitrate for ripening of the uterine cervix before induction of labour
Disease or Health Condition(s) Studied
Effects of isosorbide mononitrate 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
None
What is the research question being addressed?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Women will be randomly allocated to three groups by using stratified (primi/multi) block randomization and ISMN - SR 60mg will be inserted for 2 days (group 1) and 3 days (group 2) vaginally. Women in group 3 will be advised to self administer ISMN - SR 60mg vaginally for 3 days as an outpatient procedure.
Inclusion criteria
Consecutive women with uncomplicated singleton pregnancies having a cephalic presentation at period of gestation of 40 weeks and 3 days and having modified Bishop's score < 6.
Exclusion criteria
*Complicated pregnancies – both maternal or fetal complications *Pregnancies with uncertain dates not confirmed by early scan, even though clinically considered as 41 weeks. Multiple pregnancies *Pregnancies with contraindication for normal vaginal delivery *Pregnancies with previous caesarean section. Any contraindication for the use of ISMN.
Primary outcome(s)
|
1.
Establishment of spontaneous onset of labour within 72 hours |
[ 72 hours ] |
|
2.
Change in mean modified Bishop's score after 72 hours |
[ 72 hours ] |
|
3.
Favorable induction of labour after 72 hours. |
[ 72 hours ] |
Secondary outcome(s)
|
1.
Induction to delivery interval. |
[ After delivery ] |
|
2.
Mode of delivery. |
[ After delivery ] |
|
3.
Side effects of ISMN therapy. |
[ After delivery ] |
|
4.
Acceptance of outpatient self administration of therapy. |
[ After delivery ] |
Target number/sample size
225
Countries of recruitment
Sri Lanka
Anticipated start date
2010-09-01
Anticipated end date
2011-03-31
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2010-08-17
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
Prof. Malik Goonewardene
Professor and Head
Dept. of Obstetric and Gynaecology, Faculty of Medicine, Galle
(091) 2246878, 2234801/3, 2234730 (091) 2222314, Int: (+94)
malikg@eureka.lk
Contact Person for Public Queries
Prof. Malik Goonewardene
Professor and Head
Dept. of Obstetric and Gynaecology, Faculty of Medicine, Galle
(091) 2246878, 2234801/3, 2234730 (091) 2222314, Int: (+94)
malikg@eureka.lk
Primary study sponsor/organization
University of Ruhuna, Faculty of Medicine
P.O. Box 70, Galle, Sri Lanka
091) 2246878, 2234801/3, 2234730 94 91 2222314
malikg@eureka.lk
malikg@eureka.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
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
