Vaginal isosorbide mononitrate for ripening of the uterine cervix before induction of labour
- Conditions
- Effects of isosorbide mononitrate for pre-induction cervical ripening
- Registration Number
- SLCTR/2010/009
- Lead Sponsor
- niversity of Ruhuna, Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow up complete
- Sex
- Not specified
- Target Recruitment
- 225
Consecutive women with uncomplicated singleton pregnancies having a cephalic presentation at period of gestation of 40 weeks and 3 days and having modified Bishop's score < 6.
*Complicated pregnancies – both maternal or fetal complications
*Pregnancies with uncertain dates not confirmed by early scan, even though clinically considered as 41 weeks. Multiple pregnancies
*Pregnancies with contraindication for normal vaginal delivery
*Pregnancies with previous caesarean section. Any contraindication for the use of ISMN.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Establishment of spontaneous onset of labour within 72 hours<br> [72 hours]<br>Change in mean modified Bishop's score after 72 hours [72 hours]<br>Favorable induction of labour after 72 hours. [72 hours]<br>
- Secondary Outcome Measures
Name Time Method Induction to delivery interval. [After delivery]<br>Mode of delivery. [After delivery]<br> Side effects of ISMN therapy. [After delivery]<br>Acceptance of outpatient self administration of therapy. [After delivery]<br>
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