Effectiveness of vaginal isosorbide mononitrate for cervical ripening in uncomplicated singleton pregnancies at 39 weeks gestation in an outpatient setting: A randomized controlled trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2013/030

Enrollment

Unknown

Registered

2013-09-23

Start date

2013-10-01

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

Induction of labour

Interventions

Consenting participants will be randomized into two arms. The intervention arm will receive 5 doses of ISMN-SR 60mg to be self-administered vaginally at period of gestation (POG) of 39 weeks, 39 wee

Eligibility

Inclusion criteria

Inclusion criteria: 1. Uncomplicated pregnancy at 39 weeks POG 2. Singleton fetus having a cephalic presentation 3. Modified Bishop's Score <5 4. Consenting to self-administer the vaginal tablets every other day for five doses.

Exclusion criteria

Exclusion criteria: 1. Any pregnancy complications e.g. Pregnancy Induced Hypertension, Gestational Diabetes Melitus 2. Multiple pregnancies 3. Planned Caesarean section 4. Fetal Growth Restriction 5. History of hypersensitivity or idiosyncratic reaction to nitrates.

Design outcomes

Primary

Measure	Time frame
Spontaneous Onset Labour (SOL) between 39 weeks and 40 weeks + 2 days [ POG of 40weeks + 2 days.] Mean Modified Bishops Score (MBS) at 40weeks + 2 days [ POG of 40weeks + 2 days.] Change in mean MBS between 39 weeks and 40 weeks + 2 days. [ POG of 40weeks + 2 days.]	—

Secondary

Measure	Time frame
Mean MBS at 40 weeks + 6 days. [From 40 week + 2days to post delivery. ] Requirement of Artificial Separation of Membranes and/or vaginal PGE2 and/or intra cervical Foley catheter at 40 weeks + 6 days. [From 40 week + 2days to post delivery. ] Requirement of induction of labour with amniotomy and intra venous oxytocin infusion at 41 weeks. [From 40 week + 2days to post delivery. ] Mean induction delivery interval. [From 40 week + 2days to post delivery. ] Total dose of oxytocin used. [From 40 week + 2days to post delivery. ] Mode of delivery [From 40 week + 2days to post delivery. ] Side effects (headache, pelvic pain, nausea/vomiting, hot flushes, dizziness and palpitations) [From 40 week + 2days to post delivery. ] Maternal satisfaction (using a questionnaire) [From 40 week + 2days to post delivery. ] Neonatal outcomes [From the time of delivery up to discharge from the hospital]	—

Measure

Time frame

Mean MBS at 40 weeks + 6 days. [From 40 week + 2days to post delivery. ] Requirement of Artificial Separation of Membranes and/or vaginal PGE2 and/or intra cervical Foley catheter at 40 weeks + 6 days. [From 40 week + 2days to post delivery. ] Requirement of induction of labour with amniotomy and intra venous oxytocin infusion at 41 weeks. [From 40 week + 2days to post delivery. ] Mean induction delivery interval. [From 40 week + 2days to post delivery. ] Total dose of oxytocin used. [From 40 week + 2days to post delivery. ] Mode of delivery [From 40 week + 2days to post delivery. ] Side effects (headache, pelvic pain, nausea/vomiting, hot flushes, dizziness and palpitations) [From 40 week + 2days to post delivery. ] Maternal satisfaction (using a questionnaire) [From 40 week + 2days to post delivery. ] Neonatal outcomes [From the time of delivery up to discharge from the hospital]

—

Countries

Sri Lanka

Contacts

Public ContactProfessor Malik Goonewardene

Senior Senior Professor & Head of the department

malikg@eureka.lk091-2246878

Outcome results

None listed

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