Home » Trials » SLCTR/2007/009
The effects of two different doses of vaginal nitric oxide donor iso sorbide mononitrate used for pre induction cervical ripening on the mother and the fetus
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SLCTR Registration Number
SLCTR/2007/009
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
The effects of two different doses of vaginal nitric oxide donor iso sorbide mononitrate used for pre induction cervical ripening on the mother and the fetus
Public Title of Trial
The use of vaginal iso sorbide mononitrate to make the uterine cervix more favourable for induction of labour
Disease or Health Condition(s) Studied
Effects of vaginal Iso Sorbide Mononitrate (ISMN) 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?
Is vaginal ISMN effective for pre induction cervical ripening and is it safe for the mother and fetus ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Other
Study Phase
Not Available
Intervention(s) planned
Women will be randomly allocated to three groups by using stratified block randomization ISMN 40 mg. 60 mg SR and placebo (Vit.C 100mg) inserted vaginally
Inclusion criteria
Consecutive women with uncomplicated singleton pregnancies with cephalic presentation between 40 weeks + 5 days to 41 weeks of period of amenorrhea where the dates have been confirmed by an early ultrasound scan and having a modified Bishop score 5
Exclusion criteria
Subjects with any medical or obstetric complications or any contraindication for the use of ISMN will be excluded
Primary outcome(s)
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1.
Pulse Rate, Blood Pressure, Resistance Index, Pulsatality Index at 180 & 360 minutes & 48 hrs ,Modified Bishop Score at 375 minutes Cardiotocographs and Fetal Acoustic Stimulation Test results ,proportions establishing Spontaneous labour or becoming favourable for induction of labour or needing caesarean section within 48 hrs of the therapy ,and mode of delivery, interval and the five minute Apgar Scores of babies delivered within 72 hours of initial therapy |
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Secondary outcome(s)
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1.
Side effects of the ISMN ( headache, nausea, palpitations, hot flushes, abdominal pain, pelvic pain ) |
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Target number/sample size
156
Countries of recruitment
Sri Lanka
Anticipated start date
2006-01-03
Anticipated end date
2007-04-30
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2006-01-09
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 & Head, Department of Obstetrics & Gynaecology
Faculty of Medicine, Galle
+94(091)2246878,+94(0)112234801/3
+94(0)91 2222314
malikg@eureka.lk, malikg@med.ruh.ac.lk
Contact Person for Public Queries
Prof. Malik Goonewardene, MBBS(Cey), MS(Col), FSLCOG, FRCOG (Gt.Brit),
Professor & Head, Department of Obstetrics & Gynaecology and Consultant
Teaching hospital Galle.
+94(091)2246878,+94(0)112234801/3
+94(0)91 2222314
malikg@eureka.lk, malikg@med.ruh.ac.lk
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
