Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)

• Sponsor: KK Women's and Children's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00299754
• Collaborator: National Healthcare Group, Singapore (Other)
• Enrollment: 171
• Location: 1
• Duration (Months): 23
• Patients Per Site Per Month: 7.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Induction of Labour	Drug: Misoprostol	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: The Randomised-Controlled Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)
• Study Start Date: Jan 1, 2003
• Study Completion Date: Dec 1, 2004

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National University Hospital	Singapore		Singapore	119074

Sponsors and Collaborators

• KK Women's and Children's Hospital
• National Healthcare Group, Singapore

Investigators

• Principal Investigator: Thiam-Chye Tan, KK Women's and Children's Hospital
• Principal Investigator: Tseng-Meng Chua, National University Hospital, Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00299754
• Other Study ID Numbers: TCTan001
• First Posted: Mar 7, 2006
• Last Update Posted: Mar 7, 2006
• Last Verified: Jun 1, 2005

• Keywords provided by , ,: Low dose misoprostol; dinoprostone; cervical priming
• Additional relevant MeSH terms: Misoprostol

Study Results

No Results Posted as of Mar 7, 2006