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Vaginal isosorbide mononitrate for ripening of the uterine cervix before induction of labour

Not Applicable
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
Inclusion Criteria

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.

Exclusion Criteria

*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
NameTimeMethod
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
NameTimeMethod
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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