NCT00148473

Brief Summary

The purpose of this study is to compare the efficacy between a single dose of oral misoprostol 100 microgram and vaginal misoprostol 50 microgram for induction of labor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2001

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

September 8, 2005

Status Verified

September 1, 2005

First QC Date

September 6, 2005

Last Update Submit

September 6, 2005

Conditions

Termed Pregnancy With Indications for Labor Induction.

Keywords

Cervical ripening.Induction of labor.Misoprostol.

Outcome Measures

Primary Outcomes (1)

  • The time interval from induction to vaginal delivery and vaginal delivery rate within 24 hours.

Secondary Outcomes (6)

  • Rate of vaginal delivery within 24 hours.

  • Cesarean section rate.

  • Uterine tachysystole.

  • Uterine hyperstimulation syndrome.

  • Number of women received oxytocin.

  • +1 more secondary outcomes

Interventions

MisoprostolDRUG

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A live singleton pregnancy at a gestation of \>37 weeks, with obstetric or medical indications for induction, and unfavorable cervix (the initial Bishop score of \<717), vertex presentation, reactive fetal heart rate pattern, absence of labor, and intact membranes without previous stripping. Post-term inductions were considered when gestational age was \>41 weeks.

You may not qualify if:

  • Suspected cephalo-pelvic disproportion, estimated fetal weight of \>4000 grams, maternal age of \<18 years, parity of \>5, previous cesarean delivery or history of uterine incision, any contraindication for vaginal delivery or prostaglandins administration and suspected chorioamnionitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BMA Medical College and Vajira Hospital

Bangkok, Bangkok, 10300, Thailand

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Manit Sripramote, MD

    BMA Medical College and Vajira Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

March 1, 2000

Study Completion

October 1, 2001

Last Updated

September 8, 2005

Record last verified: 2005-09

Locations

TH(1)