NCT00299754

Brief Summary

Most studies of labour induction with misoprostol used doses higher than 25mg and intervals of 3-4 hours. We studied a low-dose regime of 25mg misoprostol and compared its efficacy as single dose or double dose with dosing interval of 6 hours to our current regime of 3 mg dinoprostone pessary.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
171

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2003

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2006

Completed
Last Updated

March 7, 2006

Status Verified

June 1, 2005

First QC Date

March 6, 2006

Last Update Submit

March 6, 2006

Conditions

Induction of Labour

Keywords

Low dose misoprostoldinoprostonecervical priming

Outcome Measures

Primary Outcomes (1)

  • The primary outcome was the number of women who achieved favourable mBS>6 or active labour by Day 2.

Secondary Outcomes (1)

  • Secondary outcomes were time interval from insert to active labour or delivery, abnormal uterine activity, delivery method and adverse neonatal outcome.

Interventions

MisoprostolDRUG

Eligibility Criteria

Age0 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • singleton pregnancy, cephalic presentation, gestation greater than 37 completed weeks, no known contraindication to vaginal delivery, and Bishop score≤5.

You may not qualify if:

  • previous caesarean section or other uterine surgery, significant maternal medical/obstetric complication in pregnancy (such as severe pre-eclampsia, significant antepartum haemorrhage), antepartum evidence of fetal compromise (such as fetal growth restriction), previous attempt at cervical priming, contraindication to receiving prostaglandins, including asthma and glaucoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (1)

  • Rath W. A clinical evaluation of controlled-release dinoprostone for cervical ripening--a review of current evidence in hospital and outpatient settings. J Perinat Med. 2005;33(6):491-9. doi: 10.1515/JPM.2005.087.

    PMID: 16318611RESULT

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Thiam-Chye Tan

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Tseng-Meng Chua

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 6, 2006

First Posted

March 7, 2006

Study Start

January 1, 2003

Study Completion

December 1, 2004

Last Updated

March 7, 2006

Record last verified: 2005-06

Locations

SG(1)