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


SLCTR Registration Number


Date of Registration

24 Aug 2007

The date of last modification

Mar 03, 2019

Trial Status

Application Summary

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


Public Acronym


Brief title


Universal Trial Number


Any other number(s) assigned to the trial and issuing authority


Trial Details

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


Study design


Randomized controlled trial


Double blinded







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)


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


Secondary outcome(s)


Side effects of the ISMN ( headache, nausea, palpitations, hot flushes, abdominal pain, pelvic pain )


Target number/sample size


Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status

Complete: follow up complete

Funding source


Regulatory approvals

State of Ethics Review Approval



Date of Approval


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 & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Prof. Malik Goonewardene,
Professor & Head, Department of Obstetrics & Gynaecology
Faculty of Medicine, Galle

+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(0)91 2222314
malikg@eureka.lk, malikg@med.ruh.ac.lk

Primary study sponsor/organization


Secondary study sponsor (If any)


Trial Completion details

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


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results