The use of vaginal iso sorbide mononitrate to make the uterine cervix more favourable for induction of labour

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2007/009
• Date of registration: 24/08/2007
• Primary sponsor: Nil
• Public title: The use of vaginal iso sorbide mononitrate to make the uterine cervix more favourable for induction of labour
• Scientific title: 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
• Date of first enrolment: 3/1/2006
• Target sample size: 156
• Recruitment status: Completed
• URL: http://www.slctr.lk/trial_details.asp?reg_id={A7B733C0-4CEB-4809-B0FF-864034F7845C}
• Study type: Interventional
• Study design: Double Blind Randomized Controlled Trial

Countries of recruitment

Sri Lanka

Contacts

• Name: Prof. Malik Goonewardene
• Affiliation: Professor and Head, Department of Obstetrics and Gynaecology

• Name: Prof. Malik Goonewardene
• Affiliation: MBBS(Cey), MS(Col), FSLCOG, FRCOG (Gt.Brit),

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Effects of vaginal Iso Sorbide Mononitrate (ISMN) for pre induction cervical ripening

Intervention(s)

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

Primary Outcome(s)

Pulse Rate, Blood Pressure, Resistance Index, Pulsatality Index at 180 andamp; 360 minutes andamp; 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 )

Secondary ID(s)

Nil

Source(s) of Monetary Support

Nil