Home » Trials » SLCTR/2016/024


Oral misoprostol for 48 hours versus an intracervical Foley catheter for 48 hours for induction of labour in post dated pregnancies : a randomized control trial -

SLCTR Registration Number

SLCTR/2016/024


Date of Registration

12 Oct 2016

The date of last modification

Oct 12, 2016



Application Summary


Scientific Title of Trial

Oral misoprostol for 48 hours versus an intracervical Foley catheter for 48 hours for induction of labour in post dated pregnancies : a randomized control trial


Public Title of Trial

Oral misoprostol compared to intracervical Foley catheter for induction of labour


Disease or Health Condition(s) Studied

Induction of labour


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

None


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

30.08.2016:3.10 (ERC: Ruhuna)


Trial Details


What is the research question being addressed?

Are three doses of oral Misoprostol 50 micrograms given four hours apart per day for 48 hours (maximum 6 doses) more effective than the insertion of an intracervical Foley catheter for 48 hours, for induction of labour in post dated pregnancies?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded


Control

Active


Assignment

Parallel


Purpose

Treatment


Phase

Phase 3


Intervention(s) planned

Study setting: Antenatal ward of Academic Obstetric Unit, Teaching Hospital, Mahamodera Galle.

Stratified (primiparous / multiparous) block randomisation, using computer generated random numbers and sequential allocation using sealed opaque envelopes will be used to allocate participants into the two arms of the trial.

Arm 1 will be administered three doses of oral Misoprostol 50 micrograms, given four hours apart per day for 48 hours (maximum 6 doses).

Arm 2 will have insertion of an intracervical Foley catheter for 48 hours.

Single blinding will be ensured as the investigator assessing the outcomes will be blinded to the interventional status.


Inclusion criteria

  1. Women with uncomplicated pregnancies
  2. 40 weeks + 5 days gestation
  3. Modified Bishop score (MBS) of < 6
  4. Singleton pregnancy
  5. Cephalic presentation
  6. Intact membranes

Exclusion criteria

  1. Pregnancy induced hypertension
  2. Gestational diabetes mellitus
  3. Fetal growth restriction
  4. Previous caesarean delivery
  5. Scarred uterus
  6. Hypersensitivity to misoprostol
  7. Contraindication for a vaginal delivery


Primary outcome(s)

    1. Number of women establishing labour or becoming favorable for induction of labour (IOL) with Modified Bishop’s Score (MBS) > 6 within 48 hours

    2. Change in MBS after 48 hours of the intervention

    3. Intervention to delivery time in those who established labour following intervention at 40 weeks + 5 days of gestation

    4. The induction delivery interval (IDI),following IOL with antimony and oxytocin 48 hours after the interventions, in those favorable for IOL

    [

    After 48 hours of the intervention

    ]

Secondary outcome(s)

    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 • Uterine Hyperstimulation • Uterine rupture • Maternal infection during labour • Use of intravenous antibiotics

    4. Fetal and Neonatal outcome and morbidity: • Suspicious cardiotocogram (CTG) • Pathological CTG • Birth weight • Meconium-stained liquor • APGAR scores < 5 at 1 minute • Admission to the neonatal ward / NICU and its reason

    [

    At the time of discharge of the mother and the baby from the hospital

    ]

Target number/sample size

144 (72 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2016-10-17


Anticipated end date

2016-10-17


Date of first enrollment


Date of study completion


Recruitment status

Pending


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

Professor Malik Goonewardene
Senior Professor & Chair
Department of Obstetrics and Gynecology, Faculty of Medicine, University of Ruhuna, PO Box 70, Galle, Sri Lanka.
Tel: +94 91 2246878
Mob: +94 0777 921051
Fax: +94 91 2222314
malikg@eureka.lk

Contact Person for Public Queries

Dr. J.P.B.Asela Amarasena
Registrar
Teaching Hospital, Mahamodara, Galle, Sri Lanka
Tel: +94 91 2246878
Mob: +94 071 6156893

amarasenaasela@gmail.com


Primary study sponsor/organization

Department of Obstetrics and Gynecology Faculty of Medicine, University of Ruhuna

PO Box 70, Galle, Sri Lanka.
Tel: +94 91 2246878
Fax: +94 91 2222314
malikg@eureka.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


Protocol URL


Results summary available


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results