Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor

May 11, 2016 updated by: Dra Angels Vives Argilagós, Consorci Sanitari de Terrassa

Prospective Randomized Clinical Trial Comparing the Effect of Vaginal Misoprostol Synchronously With Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor

Demonstrate that with concomitant and synchronous use of supracervical balloon and vaginal misoprostol for induction of labour, vaginal delivery is achieved in less time compared with vaginal misoprostol alone.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08227
        • Recruiting
        • Consorci Sanitari de Terrassa
        • Contact:
          • Angels Vives Argilagós, MI
          • Phone Number: 7098 937310007
          • Email: MAVives@cst.cat
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria:

  • Singleton pregnancy
  • Cephalic presentation
  • Reassuring fetal heart rate pattern
  • Intact membranes
  • Bishop score less than 6

Exclusion criteria

  • Severe preeclampsia
  • Prematurity ( < 37 weeks gestation dated by first trimester ultrasound)
  • Previous cesarean section or previous uterine surgery
  • Intrauterine growth restriction
  • Premature rupture of membranes
  • Maternal colonization with Streptococcus Agalactiae at any time during pregnancy
  • Multifetal pregnancy
  • Breech presentation
  • Stillbirth
  • Any contraindication for vaginal delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vaginal misoprostol alone
Women in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol according to local protocols
Drug: Misoprostol
Administration of 25 mcg of vaginal misoprostol every 4 hours up to 5 doses
Other Names:
  • Misofar
Experimental: Vaginal misoprostol + Foley catheter
Women in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. At the same time a 16French Foley catheter will be inserted through the internal os with visualization of the cervix by sterile speculum examination. The catheter balloon will be inflated with 30 ml of sterile normal saline solution and then the catheter will be taped with gentle traction to the inner thigh of the patient until spontaneous expulsion. If this does not occur, the catheter will be deflated and removed after 12 hours. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol.
Drug: Misoprostol
Administration of 25 mcg of vaginal misoprostol every 4 hours up to 5 doses
Other Names:
  • Misofar
Device: Foley catheter
Insertion of a Foley catheter (16French) through the internal os for a maximum of 12 hours
Other Names:
  • Supracervical balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Induction to delivery time
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Bishop score at 12 hours from the onset of induction
Time Frame: 1 year
1 year
Bishop score at 24 hours from the onset of induction
Time Frame: 1 year
1 year
Number of doses of misoprostol required
Time Frame: 1 year
1 year
Percentage of pregnant women requiring oxytocin
Time Frame: 1 year
1 year
Maximum dosage of oxytocin given (mU / min)
Time Frame: 1 year
1 year
Percentage of pregnant women requiring epidural analgesia
Time Frame: 1 year
1 year
Percentage of pregnant women with tachysystole and / or hypertonus with absence of fetal heart rate decelerations
Time Frame: 1 year
1 year
Percentage of pregnant women with tachysystole and / or hypertonus with fetal heart rate decelerations
Time Frame: 1 year
1 year
Percentage of pregnant women with intrapartum fever
Time Frame: 1 year
1 year
Percentage of pregnant women with maternal side effects
Time Frame: 1 year
1 year
Percentage of pregnant women with vaginal delivery within 12 hours from the onset of induction
Time Frame: 1 year
1 year
Percentage of pregnant women with vaginal delivery within 24 hours from the onset of induction
Time Frame: through study completion
through study completion
Total rate of cesarean section
Time Frame: 1 year
1 year
Percentage of cesarean sections for failed induction
Time Frame: 1 year
1 year
Percentage of cesarean sections for nonreassuring fetal status
Time Frame: 1 year
1 year
Neonatal intensive care unit admission
Time Frame: 1 year
1 year
Apgar score at 5 minutes
Time Frame: 1 year
1 year
Umbilical artery ph
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari de Terrassa

Investigators

  • Principal Investigator: Àngels Vives Argilagós, MD, Consorci Sanitari de Terrassa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-002061-29 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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