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Home » Trials » SLCTR/2014/008

Vaginal Prostaglandin E2 versus oxytocin for induction of labour in women with pre-labour rupture of membranes at term

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SLCTR Registration Number

SLCTR/2014/008

Date of Registration

06 Apr 2014

The date of last modification

Mar 03, 2019

Trial Status


Application Summary

Scientific Title of Trial

Vaginal Prostaglandin E2 versus oxytocin for induction of labour in women with pre-labour rupture of membranes at term

Public Title of Trial

Vaginal Prostaglandin E2 versus oxytocin for induction of labour in women with pre-labour rupture of membranes at term

Disease or Health Condition(s) Studied

Induction of labour

Scientific Acronym

none

Public Acronym

None

Brief title

None

Universal Trial Number

U1111-1152-3225

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

P/02/01/2014 (Ethics Review Committee, Faculty of Medicine, University of Kelaniya)


Trial Details

What is the research question being addressed?

What is the effectiveness and acceptability of vaginal prostaglandin E2 for induction of labour in women with pre-labour rupture of membranes (PROM) at term?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Double blinded

Control

Active

Assignment

Parallel

Purpose

Other

Study Phase

Not Applicable

Intervention(s) planned

Computer generated random numbers will be used to allocate participants into the study and control groups by stratified (primiparous, multiparous) block randomization.

Rupture of membranes will be confirmed by speculum examination by the investigator and cervical assessment will be done at the same time. The time at which membrane rupture had occurred will be considered as the starting point of time line and all events will be carried out in relation to that. Study group: Six hours after rupture of membranes, Prostaglandin E2 3mg tablet will be inserted to posterior vaginal fornix and cardio-tocographic (CTG) assessment will be done at 2 hours and 4 hours after prostaglandin E2 insertion. If woman goes in to labour she will be admitted to labour ward and will allow to progress. If labour does not occur after 6 hours of prostaglandin E2 insertion (twelve hours after rupture of membranes) women will be admitted to labour ward and oxytocin infusion will be started. Control group:. If woman goes in to labour she will be admitted to labour ward and will allow to progress. Cardio-tocographic (CTG) assessment will be done after admission. If labout does not occur after 06 hours of membrane rupture, women will be admitted to labour ward and oxytocin infusion will be started.

Oxytocin infusion in both groups will be carried out using infusion pumps according to unit protocol. Progress of labour will be assessed by a medical officer and will be documented on partograms.

Inclusion criteria

  1. Ruptured membranes confirmed by speculum examination
  2. Period of amenorrhoea of 37 weeks or more
  3. Single fetus in cephalic presentation
  4. Unfavorable cervix (Modified Bishops score of 6 or less).

Exclusion criteria

  1. Active labour
  2. Previous caesarian section
  3. Meconium staining of amniotic fluid
  4. Maternal fever

Primary outcome(s)

1.

  1. Caesarean section rate – percentage of caesarean sections out of the total number of inductions for each arm.

  2. Post partum maternal fever – Axillary temperature will be measured four times a day. Temperature rise above 100.4 0F (38 0C) maintained over 24 hours during first 72 hours of delivery will be considered as post partum maternal fever

  3. SCBU admission – Admission and stay for more than 24 hours in SCBU

  4. Neonatal fever – Axillary temperature will be measured four times a day. Temperature rise above 100.4 0F (38 0C) maintained over 24 hours during first 72 hours will be considered as neonatal fever.

  5. Induction to delivery interval – duration from protaglandin insertion to delivery of the baby will be considered as induction to delivery interval for study group. Duration from starting oxytocin to delivery of the baby will be considered as induction to the control group.

[
  1. From recruitment to delivery of the baby
  2. Four times daily for 72 hours after delivery
  3. From delivery of the baby to discharge from hospital
  4. Four times daily for 72 hours after delivery
  5. From point of induction (prostaglandin insertion ) for study group and from starting oxytocin infusion (for control group) until delivery of the baby.
]

Secondary outcome(s)

1.

None

 [

None

]

Target number/sample size

150

Countries of recruitment

Sri Lanka

Anticipated start date

2014-04-15

Anticipated end date

2014-06-05

Date of first enrollment

Date of study completion

Recruitment status

Pending

Funding source

None

Regulatory approvals


State of Ethics Review Approval

Status

Approved

Date of Approval

2014-01-08

Approval number

P/02/01/2014

Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Kelaniya
Institutional Address:PO Box 6, Thalagolla Road, Ragama Sri Lanka
Telephone:+94-11-2961267
Email: erckelaniya@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

D P L Rasanjana
Registrar (Obstetrics & Gynaecology)
Professorial Obstetrics & Gynaecology unit, North Colombo Teaching Hospital, Ragama.

0714822735

lanka.rasanjana@yahoo.com

Contact Person for Public Queries

Prof. P.S. Wijesinghe
Professor in Obstetrics & Gynaecology
Professorial Obstetrics & Gynaecology unit, North Colombo Teaching Hospital, Ragama.

0714739685

prashanthaw@gmail.com

Primary study sponsor/organization

Professorial Obstetrics & Gynaecology Unit,

North Colombo Teaching Hospital, Ragama.



Secondary study sponsor (If any)







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


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