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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2007/009

Enrollment

156

Registered

2007-08-24

Start date

2006-01-03

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Inclusion 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

Exclusion criteria: Subjects with any medical or obstetric complications or any contraindication for the use of ISMN will be excluded

Design outcomes

Primary

Measure	Time frame
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 []	—

Measure

Time frame

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

Measure	Time frame
Side effects of the ISMN ( headache, nausea, palpitations, hot flushes, abdominal pain, pelvic pain ) []	—

Countries

Sri Lanka

Contacts

Public ContactProf. Malik Goonewardene,

Professor & Head, Department of Obstetrics & Gynaecology

malikg@eureka.lk, malikg@med.ruh.ac.lk+94(091)2246878,+94(0)112234801/3

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026