Effectiveness and Safety of Induction of Labour Using a Double Balloon Catheter (INDOBA) (INDOBA)

November 12, 2019 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

The goal of induction of labor is to achieve vaginal delivery by stimulating uterine contractions before the spontaneous onset of labor. Generally, induction of labor has merit as a therapeutic option when the benefits of expeditious delivery outweigh the risks of continuing the pregnancy.

The first part of this process is called cervical ripening. The goal is to facilitate the process of cervical softening, thinning, and dilating with resultant reduction in the rate of failed induction and induction to delivery time. Cervical remodeling is a critical component of normal parturition.

Effective methods for cervical ripening include the use of mechanical and pharmacological methods.

There are many induction methods: pharmacological and mechanical.

Nowadays, induction of labour is one of the most frequent obstetric interventions, performed in 25% of pregnancies. Generally, better maternal and neonatal outcomes are achieved if the risks of continuing pregnancy outweigh the benefits.

Cervical ripening is the first part of the induction process, which consists in relaxing and softening the uterine cervix prior to the onset of uterine dynamics.

For this purpose, there are available pharmacological (mainly prostaglandin) and mechanical methods (including the balloon probes: Foley catheter or double cervical balloon). Despite being equally effective in vaginal delivery and caesarean section rate, there has been registered an increased risk of uterine hyperdynamic with the use of prostaglandin in contrast to the use of balloon probes, which may lead to an increased risk of fetal distress.

Concerning balloon probes, various published studies conclude that it is an effective and safe cervical ripening method, without increasing the risk of maternal infection (chorioamnionitis / endometritis) or neonatal infection.

The use of balloon probes could be established as first-choice method of induction of labour, reducing the risk of uterine hyperdynamic and the likelihood of intrauterine fetal distress derived from the use of prostaglandin.

The balloon probe safety makes it an ideal method for performing cervical ripening at home (out-patient) in low-risk pregnancies, increasing the satisfaction of women who desire it and reducing the economic cost for the hospital.

The purpose of this study is to assess the effectiveness and safety of double balloon catheter (CRB-Cook®) in induction of labour.

The main objective is to provide evidence that there are no differences in caesarean section rate between induction of labour performed with Cook double balloon catheter in out-patient and in-patient compared with a cohort of induction of labour with pharmacological methods (dinoprostone and misoprostol).

Two clinical studies will be carried out for this purpose:

  1. Prospective cohort observational study
  2. Historical case-control study

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

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, Spain, 08025
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women

Description

Inclusion Criteria:

  • Pregnant women
  • Age: ≧ 18 years
  • Ability to read and understand informed consent
  • Unique or multiple pregnancies (monochorionic or dichorionic twins)
  • ≧37 weeks of pregnancy
  • Unfavourable cervix (Bishop test: < 7)

Exclusion Criteria:

  • >2 foetus pregnancies
  • < 37 or ≧42 weeks of pregnancy
  • Prelabour rupture of membranes

  • Vaginal delivery contraindication

    • Placenta previa (occlusive and not occlusive)
    • Vasa previa
    • Transverse or oblique lie
    • Umbilical cord procubitus or prolapse
    • Corporal uterine surgery with entrance into the uterine cavity
    • Antecedent of ≧ 2 caesarean section
    • Antecedent of inverted T caesarean section
    • Antecedent of uterine rupture
    • Active genital herpes infection
    • Cervical carcinoma
    • Severe maternal pathology
  • Breech lie
  • ≥ 7 Bishop score
  • Non-reassuring fetal cardiotocographic registration
  • Indication of immediate delivery
  • Stillbirth of malformed foetus

Also, patients to be included in the out-patient group should comply with the following criteria:

Inclusion criteria:

  • Low-risk pregnancies
  • ≤ 2 previous deliveries
  • Patient acceptation and good comprehension of the instructions
  • Maximum 30 minutes of distance to the hospital.
  • Possibility of telephone communication at any moment
  • To be accompanied by someone during the entire process at home

Exclusion criteria:

- Positive screening for vaginal / rectum group B streptococcal infection

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness Vaginal delivery / caesarean section rate
Time Frame: 12 months
Measure vaginal delivery and caesarean rate of induction of labour with double balloon catheter
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of patient and foetus
Time Frame: 12 months
Measured through complications and adverse effects registered during induction of labour
12 months
Patients satisfaction
Time Frame: 12 months
Measured as global satisfaction with the use of double balloon catheter as induction of labour method with an analog visual scale from 0 to 10
12 months

Collaborators and Investigators

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

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

  • Principal Investigator: Elisa Llurba, MD, PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

Helpful Links

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 (Actual)

October 10, 2019

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

February 2, 2021

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Actual)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIBSP-CRB-2019-70

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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