Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study) - Full Text View

Sponsor:	KK Women's and Children's Hospital
Collaborator:	National Healthcare Group, Singapore
Information provided by:	KK Women's and Children's Hospital
ClinicalTrials.gov Identifier:	NCT00299754

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Dose Comparison 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:

Drug Information available for: Misoprostol Dinoprostone

U.S. FDA Resources

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

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:

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.

Study ID Numbers:	TCTan001
Study First Received:	March 6, 2006
Last Updated:	March 6, 2006
ClinicalTrials.gov Identifier:	NCT00299754 History of Changes
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:

Dinoprostone
Oxytocics
Therapeutic Uses
Anti-Ulcer Agents
Abortifacient Agents
Physiological Effects of Drugs

Misoprostol
Gastrointestinal Agents
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 18, 2010