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

SLCTR/2007/009


Date of Registration

24 Aug 2007

The date of last modification

Jun 07, 2013


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 of 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


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

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Placebo


Assignment

Parallel


Purpose


Purpose


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


Primary outcome(s) - Time of assessment(s)


Secondary outcome

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


Secondary outcome(s) - Time of assessment(s)



Target number/sample size

156


Countries of recruitment

Sri Lanka


Anticipated start date

2006-01-03


Anticipated end date

2007-04-30


Recruitment status

Complete


State of ethics review approval

Approved by the Ethics Review Committee of the Faculty of Medicine, University of Ruhuna


Funding source

None



Contact & Sponsor Information


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


Primary study sponsor/organization

None





Secondary study sponsor (If any)

None