Efficacy and Safety of Titrated Oral Misoprostol Solution for Labor Induction at Term

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01070472

Enrollment

250

Registered

2010-02-18

Start date

2010-03-31

Completion date

2011-06-30

Last updated

2013-12-10

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

Conditions

Labor Induction at Term

Keywords

labor induction at term using a titrated oral misoprostol solution

Brief summary

The purpose of this study is to determine whether a titrated solution of oral Misoprostol is safe and effective at inducing labor at term, regardless of Bishop Score.

Interventions

DRUGMisoprostol

titrated oral misoprostol solution

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 44 Years

Healthy volunteers

Inclusion criteria

1. term, 2. singleton 3. no contraindication to prostaglandins 4. vertex 5. no exposure to vaginal prostaglandins in the index pregnancy

Exclusion criteria

1. parity \> 3 2. severe PIH: BP\> 160/100, abnormal LFT's, proteinuria \>1g/day 3. previous uterine surgery 4. regular uterine contractions 5. maternal age \> 45 6. twins

Design outcomes

Primary

Measure	Time frame
Rate of vaginal delivery within 24 hours	24 hours

Secondary

Measure	Time frame
Uterine hyperstimulation rate	24 hours

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026