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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00299754
Other study ID # TCTan001
Secondary ID
Status Completed
Phase Phase 3
First received March 6, 2006
Last updated March 6, 2006
Start date January 2003
Est. completion date December 2004

Study information

Verified date June 2005
Source KK Women's and Children's Hospital
Contact n/a
Is FDA regulated No
Health authority Singapore: Health Sciences Authority
Study type Interventional

Clinical Trial 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.


Description:

171 women with singleton term pregnancies and modified Bishop score (mBS) ≤ 5 were recruited and randomized into 3 arms: current dinoprostone regime, double dose misoprostol or single dose misoprostol. The primary outcome was the number of women who achieved favourable mBS>6 or active labour by Day 2. Secondary outcomes were time interval from insert to active labour or delivery, abnormal uterine activity, delivery method and adverse neonatal outcome.


Recruitment information / eligibility

Status Completed
Enrollment 171
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Misoprostol


Locations

Country Name City State
Singapore National University Hospital Singapore

Sponsors (2)

Lead Sponsor Collaborator
KK Women's and Children's Hospital National Healthcare Group, Singapore

Country where clinical trial is conducted

Singapore, 

References & 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome was the number of women who achieved favourable mBS>6 or active labour by Day 2.
Secondary Secondary outcomes were time interval from insert to active labour or delivery, abnormal uterine activity, delivery method and adverse neonatal outcome.
See also
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