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

University of Manitoba

Status: Completed

Conditions: Labor Induction at Term

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01070472

B2009:149

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)