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Home » Trials » SLCTR/2014/030

A randomized control trial to compare the effectiveness of intracervical Foley catheter for 24 hours vs three doses of oral misoprostol for preinduction cervical ripening in post dated pregnancies

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SLCTR Registration Number

SLCTR/2014/030

Date of Registration

21 Nov 2014

The date of last modification

Mar 11, 2020

View original TRDS

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Trial Status


Application Summary

Scientific Title of Trial

A randomized control trial to compare the effectiveness of intracervical Foley catheter for 24 hours vs three doses of oral misoprostol for preinduction cervical ripening in post dated pregnancies

Public Title of Trial

Comparison of oral misoprostol vs intracervical Foley catheter for 24 hours for preparation of uterine cervix before induction of labour

Disease or Health Condition(s) Studied

Cervical ripening

Scientific Acronym

none

Public Acronym

none

Brief title

Oral misoprosrol vs Foley catheter for pre induction cervical ripening

Universal Trial Number

None

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

None


Trial Details

What is the research question being addressed?

Are three doses of oral misoprostol 50 micrograms given four hourly better than the insertion of an intracervical Foley catheter for 24 hours, for pre induction cervical ripening in post dated pregnancies?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Single blinded

Control

Standard therapy/practice

Assignment

Parallel

Purpose

Supportive care

Study Phase

Not Available

Intervention(s) planned

Using computer generated random numbers, a stratified (primip/multip) block randomization technique and sequentially numbered sealed opaque envelopes, women fulfilling the inclusion criteria admitted to the antenatal ward will randomized in to the two arms.
Arm 1 - three doses of oral Misoprostol 50 micrograms four hourly Arm 2 - Intra cervical foley catheter for 24 hours.

Inclusion criteria

  1. Women with uncomplicated pregnancies at 40 weeks+ 6 days gestation with a Modified Bishop score (MBS)<5
  2. Having a singleton fetus in a cephalic presentation

Exclusion criteria

  1. Pregnancy Induced Hypertension
  2. Gestational Diabetes Mellitus
  3. Multiple pregnancies
  4. Planned Caesarean section,
  5. Fetal Growth Restriction ,
  6. Scarred uteruses

Primary outcome(s)

1.
  1. Number of women establishing spontaneous onset of labour (SOL) within 24 hours of the interventions.
  2. MBS after 24 hours of the interventions
  3. The change of MBS after 24 hours of the interventions
  4. Number of women with MBS> 7 after 24 hours of the interventions
  5. The induction delivery interval following Induction of labor (IOL) with amniotomy and oxytocin intravenous infusion,24 hours after the interventions, in those favourable for IOL
 [

After 24 hours of the interventions

]

Secondary outcome(s)

1.
  1. Mode of delivery and the reason for operative delivery
  2. Oxytocin use

  3. Maternal morbidity • Post partum blood transfusion and number of packed cells • Tachysystole • Hyperstimulation • Uterine rupture • Maternal infection during labour • Use of intravenous antibiotics

    1. Fetal and Neonatal outcome and morbidity: • Fetal tachycardia • Weight at birth • Meconium-stained liquor • Apgar scores <5 at 1 minute • Admission to the neonatal ward/NICU and its reason
 [

Between 24 to 48 hours after the intervention

]

Target number/sample size

220(110 each arm)

Countries of recruitment

Sri Lanka

Anticipated start date

2014-11-24

Anticipated end date

2015-04-30

Date of first enrollment

2014-11-24

Date of study completion

Recruitment status

Complete: follow up complete

Funding source

Department of Obsterics and Gynecology of the Faculty of Medicine,University of Ruhuna

Regulatory approvals


State of Ethics Review Approval

Status

Approved

Date of Approval

2014-08-19

Approval number

Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Ruhuna
Institutional Address:PO Box 70, Labuduwa Rd, Galle, Sri Lanka
Telephone:+94-91-2234801/803 (Extension: 161)
Email: ethics@med.ruh.ac.lk

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Pofessor Malik Goonewardene
Senior professor & Head
Department of Obstetrics and Gynecology of the Faculty of Medicine,University of Ruhuna, PO Box 70, Galle Sri Lanka.
+94 91 2246878

+94 91 2246878
malkg@ureka.lk

Contact Person for Public Queries

Dr.D.P.Somirathne
Registrar(Obsterics &Gynecology)
Teaching Hospital,Mahamodara,Galle Srilanka.
+94 91 2246878
+94 772 604234

dsomirathne86@gmail.com

Primary study sponsor/organization

Department of Obstetrics & Gynecology

Faculty of Medicine,University of Ruhuna, PO Box 70, Galle Sri Lanka.
+94 91 2246878
+94 91 2246878
malkg@ureka.lk

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


  • Trial Options