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

Efficacy of two different treatment regimens of vaginal nitric oxide donor (Isosorbide mononitrate) used for pre-induction cervical ripening: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2010/009
Enrollment
225
Registered
2010-10-11
Start date
2010-09-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Effects of isosorbide mononitrate for pre-induction cervical ripening

Interventions

Women will be randomly allocated to three groups by using stratified (primi/multi) block randomization and ISMN - SR 60mg will be inserted for 2 days (group 1) and 3 days (group 2) vaginally. Women in

Sponsors

University of Ruhuna, Faculty of Medicine
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Establishment of spontaneous onset of labour within 72 hours [72 hours] Change in mean modified Bishop's score after 72 hours [72 hours] Favorable induction of labour after 72 hours. [72 hours]

Secondary

MeasureTime frame
Induction to delivery interval. [After delivery] Mode of delivery. [After delivery] Side effects of ISMN therapy. [After delivery] Acceptance of outpatient self administration of therapy. [After delivery]

Countries

Sri Lanka

Contacts

Public ContactProf. Malik Goonewardene

Professor and Head

malikg@eureka.lk(091) 2246878, 2234801/3, 2234730 (091) 2222314, Int: (+94)

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Sep 19, 2026