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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00299754
First Posted: March 7, 2006
Last Update Posted: March 7, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Healthcare Group, Singapore
Information provided by:
KK Women's and Children's Hospital
  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
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)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: March 6, 2006
First Posted: March 7, 2006
Last Update Posted: March 7, 2006
Last Verified: June 2005

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
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics