Home » Trials » SLCTR/2008/002


A randomised controlled trial comparing intra-vaginal Misoprostol with trans-cervical Foley catheter for the pre-induction cervical ripening -

SLCTR Registration Number

SLCTR/2008/002


Date of Registration

28 Mar 2008

The date of last modification

Nov 21, 2017


Trial Status



Application Summary


Scientific Title of Trial

A randomised controlled trial comparing intra-vaginal Misoprostol with trans-cervical Foley catheter for the pre-induction cervical ripening


Public Title of Trial

To compare the effectiveness of trans-cervical foley catheter and intravaginal Misoprostol in making the uterine cervix more favourable for induction of labour


Disease or Health Condition(s) Studied

Effectiveness of trans-cervical foley catheter and intra-vaginal Misoprotol for pre induction cervical ripening


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

None


Any other number(s) assigned to the trial and issuing authority

EC/07/094 (Ethics Review Committee of the Faculty of Medicine, University of Colombo)


Trial Details


What is the research question being addressed?

Is intra-vaginal misoprostol a more effective pre induction cervical ripening agent compared to trans-cervical foley catheter ?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Active


Assignment

Parallel


Purpose


Phase


Intervention(s) planned

A patient who will be decided to undergo labour and who meet the criteria for the study will be randomized to receive either trans-cervical foley catheters or intra-vaginal misoprostol as the pre- induction cervical ripening agent.


Inclusion criteria

Consented women with singleton gestation in vertex presentation at greater than 28 weeks gestation with Bishop’s score less than 6


Exclusion criteria

•Rupture of membranes antepartum bleeding •active genital herpes infection •fetal death •placenta praevia •previous induction or pre-induction agent during the pregnancy, and known allergy to misoprostol •Women with history of cesarean deliveries will not be excluded



Primary outcome(s)

  1. Time to vaginal delivery or vaginal delivery rates within a specified time Operative delivery rates (caesarean section and instrumental vaginal delivery) •Length of labour/incidence of prolonged labour •Measures of effectiveness (oxytocin augmentation rates •epidural usage •cervix unfavorable/unchanged at 12–24 hours) •Serious maternal morbidity or death •Other adverse outcomes (e.g. uterine hypercontractility •Postpartum haemorrhage •Maternal adverse effects) •Measures of maternal satisfaction •Serious neonatal morbidity or perinatal death •Other adverse perinatal outcomes (meconium-stained liquor •Five-minute apgar score of less than seven •Neonatal intensive care unit admission)

    []

Secondary outcome(s)

  1. None

    []

Target number/sample size

100 (50 per group)


Countries of recruitment

Sri Lanka


Anticipated start date

2008-01-01


Anticipated end date

2008-01-01


Date of first enrollment


Date of study completion


Recruitment status

Suspended


Funding source

None



State of Ethics Review Approval


Status


Date of Approval


Approval number


Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:


Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. T.D. Dias
Senior Registrar
Department of Obstetrics & Gynaecology,Faculty of Medicine, University of Colombo

0773051142

thiran_dias@yahoo.com

Contact Person for Public Queries

Dr. K.M.D.J. Rodrigo
Research Associate
Department of Obstetrics & Gynaecology,Faculty of Medicine,University of Colombo

0776519518

damith_rodrigo@yahoo.com


Primary study sponsor/organization

None





Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description


Study protocol available


Protocol version and date


Protocol URL


Results summary available


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results