Home » Trials » SLCTR/2014/025


Induction of multiparous women at term using different methods: Prostaglandin E2 (dinopristone) vaginal gel, intracervical foley catheter insertion and sweeping of membrane: An open-label, randomised controlled trial.

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SLCTR Registration Number

SLCTR/2014/025


Date of Registration

09 Oct 2014

The date of last modification

Apr 30, 2019



Application Summary


Scientific Title of Trial

Induction of multiparous women at term using different methods: Prostaglandin E2 (dinopristone) vaginal gel, intracervical foley catheter insertion and sweeping of membrane: An open-label, randomised controlled trial.


Public Title of Trial

Comparison of different approaches to labour induction among multi parous women at term


Disease or Health Condition(s) Studied

Induction of labour


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

1111-1156-8163


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

None


Trial Details


What is the research question being addressed?

What is the comparative effectiveness of 3 methods, Prostaglandin E2 (dinopristone) vaginal gel, intracervical foley catheter insertion and sweeping of membrane for induction of labour in multiparous women?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Prevention


Study Phase

Not Available


Intervention(s) planned

Consenting participants meeting inclusion/exclusion criteria will be allocated to four arms using block randomization. All the induction methods will be carried out from 40+4 weeks of gestation onwards.

Arm 1 (prostaglandin group): Dinoprostone gel be 2mg will be inserted following initial cervical assessment. If the cervix is unfavourable after six hours a second dose of prostaglandin (2mg) will inserted. Fetal wellbeing will be monitored by CTG at three hours and five hours after insertion of prostaglandin.

Arm 2 (foley catheter group): The foley catheter balloon will inserted through the cervical canal and the catheter bulb dilated with 60 ml of normal saline done. Sufficient cervical dilatation will result in the catheter dropping out. The foley catheter will be kept for a maximum of 48 hours. Fetal well being will be monitored by CTG and daily Doppler assessment.

Arm 3 (membrane sweeping group): The sweeping of membrane will done once daily till 41 weeks. Fetal well being will be monitored by CTG at 3 hours after membrane sweeping and daily Doppler assessment.

Arm 4 (control group): Spontaneous onset of labour will be awaited with fetal monitoring done daily by 20 minutes CTG and daily Doppler assessment.

All the cervical assessments will be done by the first senior house officer (SHO) and introduction of the cervical ripening induction method done by the second senior house officer. Fetal wellbeing (assessment of CTG, Doppler) will be by the third senior house officer.

Patients may exit the trial on their preference and will be excluded on development of dribbling or any life threatening complication to the mother or baby. Such situations will be managed according to standard protocols and unit policy. Grossly unfavourable induction of labour at 48 hours after intervention will be managed according to standard protocols and unit policy.


Inclusion criteria

  1. Multiparous women undergoing induction of labour at the study setting.
  2. Gestation more than 40+4 weeks
  3. Singleton pregnancy with cephalic presentation
  4. Unruptured membrane
  5. Modified Bishop Score (MBS) less than 8

Exclusion criteria

  1. Primiparity
  2. Malpresentation and unstable lie.
  3. Favourable cervix (MBS of 8 or above)
  4. Any contraindication to vaginal birth, with previous uterine surgery (including caesarean section, placenta previa and other placental anomalies)
  5. Age less than 18 years
  6. Lethal fetal congenital anomaly
  7. Known allergy to any of the interventional products


Primary outcome(s)

1.
  1. Time interval between induction of labour to vaginal delivery
  2. Rates of failed induction (needing caesarian section or second induction method)
[

Up to 72 hours after induction of labour .

]

Secondary outcome(s)

1.
  1. Requirement for oxytocin augmentation
  2. Incidence of uterine hyperstimulation
  3. Incidence of intrapartum fetal blood sampling
  4. Mode of delivery
  5. Blood loss at delivery
  6. Incidence of maternal pyrexia (>37.3°C),
  7. Perineal lacerations require suturing,
  8. APGAR score at 1 minute and 5 minutes
  9. Need for admission to a neonatal intensive care unit (NICU).
[

Up to 72 hours after induction of labour

]

Target number/sample size

(http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3564932/)


Countries of recruitment

Sri Lanka


Anticipated start date

2014-10-15


Anticipated end date

2014-11-18


Date of first enrollment


Date of study completion


Recruitment status

Recruiting


Funding source

None


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2013-12-06


Approval number

N/A


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Peradeniya
Institutional Address:Galaha Road, Kandy, Sri Lanka
Telephone:+94-812396361
Email: chairpersonierc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr.P.D.M.Pathiraja
Registrar in Obstetrics and Gynaecology
New unit for Obstetrics and Gynaecology Teaching Hospital ,Peradeniya
0812388261
0772532828

madushan_pathi@yahoo.com

Contact Person for Public Queries

Dr AGSK Ranaraja
Registrar in Obstetrics and Gynaecology
New unit for Obstetrics and Gynaecology Teaching Hospital ,Peradeniya
0812388261
0777802949

sisira2@hotmail.com


Primary study sponsor/organization

New unit for Obstetrics and Gynaecology

Teaching Hospital ,Peradeniya, Kandy, Sri Lanka
Tel: +94 812 222261
Fax: +94 812 233343
info@kandy-hospital.health.gov.lk
http://www.kandy-hospital.health.gov.lk

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

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results