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The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol

The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00886860
Enrollment
64
Registered
2009-04-23
Start date
2009-05-31
Completion date
2010-03-31
Last updated
2010-07-14

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

Conditions

Cervical Ripening, Labor Induction

Keywords

Efficacy, Cervical ripening/Labor induction, Titrated oral misoprostol/Conventional oral misoprostol, Term pregnancy

Brief summary

The purpose of this study is to compare the efficacy for cervical ripening in labor induction between titrated and conventional oral misoprostol

Interventions

DRUGmisoprostol

misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 cm

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* age 18 years old or more * singleton pregnancy at 37 weeks gestation or more * cephalic presentation * reassuring fetal heart rate pattern * admission for labor induction due to medical or obstetrical conditions * bishop score less than 6 * giving consent and having signed the consent form for this study

Exclusion criteria

* parity more than 3 * estimated fetal weight more than 3,500 grams * non-reassuring fetal heart rate pattern * having contraindication for vaginal delivery * previous uterine scar * suspected abruptio placenta with non-reassuring fetal heart rate pattern * abnormal bleeding per vagina, except bloody show * PROM * having underlying cardiac, hepatic, or renal diseases * having history of allergy to misoprostol or prostaglandin analogues * cervical dilatation 3 centimeters or more * uterine contraction 3 times or more in 10 minute

Design outcomes

Primary

MeasureTime frame
success rate of cervical ripening in labor induction12 hours after intervention

Secondary

MeasureTime frame
number of vaginal delivery24 hours

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026