Induction of Labor in Patients With Unfavorable Cervical Conditions

February 18, 2016 updated by: elad mei-dan, Hillel Yaffe Medical Center
Artificial ripening of the cervix and induction of labor remain as one of the therapeutic challenges in Obstetrics. The method widely used, the intravenous administration of Oxytocin, is associated with prolonged induction periods, a significant failure rate, and considerable patient discomfort. Therefore, over the years, a variety of locally applied pharmacological and physical ripening agents were evaluated. Currently, the commonly utilised local ripening agent is a Prostaglandin (PG) preparation. Although PG is being applied vaginally or extra-amniotically, systemic absorption of this agent is common, sometimes resulting in uterine hypertonicity, nausea and vomiting. In addition, both induction methods are associated with the initiation of uterine contractions, sometimes lasting for prolonged periods. Therefore a preferred induction method may be a mechanical one which will lead to cervical ripening without causing uterine contractions. Furthermore, there are additional potential advantages of mechanical methods compared to pharmacologic methods such as, ease of storage, low cost and less side effects. A folly catheter, inserted through the cervix, combined with continuous extra-amniotic NS instillation is being used for this purpose for many years. However this method although effective may cause uncomfortable traction of the balloon to the women's leg. Furthermore, dripping of saline through the cervix and vagina, occasionally occurs, may be annoying, and may be confused with rupture of membrane. We have recently introduced a newly developed balloon device (Atad Ripener Device), which was designed with one balloon located at the distal end of the device (the uterine balloon, U), while the other balloon is located 1.5 cm proximal to the first one (the cervicovaginal balloon, CV). Both balloons are expandable with Saline. The balloon inflated in the vagina provides the traction action and seals the cervix from saline leakage. Another balloon the AID (Atad double balloon Instillation Device) is identical to the ARD but has an additional long tip for instillation of normal to the extra-amniotic space. To the best of our knowledge, no comparison was performed between the use of the double balloon ripener device and folly catheter for induction of labor. Furthermore, there are no published data regarding the use of the double balloon instillation device (AID) combined with continuous extra-amniotic NS instillation. This study is designed to compare the efficacy, safety and side effects of mechanical methods of cervical ripening and labor induction by the double balloon device (ARD), the double balloon instillation device (AID) combined with continuous extra-amniotic instillation of normal saline and the folly catheter combined with continuous extra-amniotic normal saline instillation. The study aims at the accrual of 300 women (100 randomised in each arm).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

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

  • Israel
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center

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

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients 15 years of age or older.
  • Diagnosed to be pregnant with an indication for induction of labor.
  • Having a Bishop score of 4 points or less.
  • Diagnosed as having a singleton pregnancy in a vertex presentation, with intact membranes, and no significant regular uterine contraction at gestational age of >28 weeks.
  • Willingness to comply with the protocol for the duration of the study.
  • Have signed an informed consent.

Exclusion Criteria:

  • Any contraindication for a vaginal delivery (i.e. placenta previa, non vertex presentation).
  • Ruptured membranes.
  • Previous cesarean section or any uterine scar.
  • Documented labor.
  • Suspected fetal distress necessitating immediate intervention.
  • Proven malignancy of the cervix.
  • Active inflammatory or purulent condition of the lower genital tract.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Insertion of the Atad double balloon ripener device (100 ml NS in each balloon).
Device: ARD (Atad Ripener Device)
Atad double balloon ripener device
ACTIVE_COMPARATOR: 2
Insertion of the double balloon instillation device (100 ml NS in each balloon) and continuous extra-amniotic instillation of NS 50 Ml/hour
Device: AID (Atad double balloon Instillation Device)
Double balloon instillation device and continuous extra-amniotic instillation of NS 50 Ml/hour
ACTIVE_COMPARATOR: 3
Insertion of the folly catheter (40 ml NS in the balloon) and continuous extra-amniotic instillation of NS 50 Ml/hour
Device: folly catheter
folly catheter (40 ml NS in the balloon) and continuous extra-amniotic instillation of NS 50 Ml/hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate and compare the efficacy of the Atad Ripening Device (ARD), of the double balloon instillation device (AID) with concomitant continuous extra-amniotic NS instillation - 50 Ml/hour and of the folly catheter combined with continuous extra-a
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the safety of the induction methods.
Time Frame: 2 years
2 years
To assess the women's experience and satisfaction with the induction methods.
Time Frame: 2 years
2 years
To compare the different cervical scoring systems available for predicting a successful induction.
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Mordechai Hallak, M.D., Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2008

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

January 29, 2008

First Posted (ESTIMATE)

January 30, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • inductionCTIL
  • No grant

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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