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

This study has been completed.
Sponsor:
Collaborator:
National Healthcare Group, Singapore
Information provided by:
KK Women's and Children's Hospital
ClinicalTrials.gov Identifier:
NCT00299754
First received: March 6, 2006
Last updated: NA
Last verified: June 2005
History: No changes posted
  Purpose

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 Intervention Phase
Induction of Labour
Drug: Misoprostol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Randomised-Controlled Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)

Resource links provided by NLM:


Further study details as provided by KK Women's and Children's Hospital:

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

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

Estimated Enrollment: 171
Study Start Date: January 2003
Estimated Study Completion Date: December 2004
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00299754

Locations
Singapore
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00299754     History of Changes
Other Study ID Numbers: TCTan001
Study First Received: March 6, 2006
Last Updated: March 6, 2006
Health Authority: Singapore: Health Sciences Authority

Keywords provided by KK Women's and Children's Hospital:
Low dose misoprostol
dinoprostone
cervical priming

Additional relevant MeSH terms:
Misoprostol
Dinoprostone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on October 16, 2014