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Induction of LabourINDOBANCT04163744

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

An observational study of Induction of Labour, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Induction of Labour
What is being tested?
Double balloon catheter
Type of treatment
Medical device
How many people
200 participants
Where
1 siteSpain
Study dates
10 Oct 2019to 2 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Pregnant women

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • >2 foetus pregnancies
  • < 37 or ≧42 weeks of pregnancy
  • Prelabour rupture of membranes
  • Vaginal delivery contraindication
  • Placenta previa (occlusive and not occlusive)
  • Vasa previa
Show all 22Show fewer
  • 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:
  • Positive screening for vaginal / rectum group B streptococcal infection

Trial locations and contacts

1 site in 1 country.

Elisa Llurba, MD, PhD contact

+34935537041

ellurba@santpau.cat

Spain1 site, 1 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

    Elisa Llurba, MD, PhD, +34935537041, ellurba@santpau.cat

    Recruiting

Other trials in Spain

About this study

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.

Read more

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
Being tested
Double balloon catheter
Keywords
Induction of labour, Double balloon catheter, Vaginal delivery rate, Mechanical method, in-patient, out-patient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Double balloon catheterDevice

    Induction of labour with double balloon catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness Vaginal delivery / caesarean section rate

    Measure vaginal delivery and caesarean rate of induction of labour with double balloon catheter

    Measured: 12 months

Secondary outcomes (2)

  1. Safety of patient and foetus

    Measured through complications and adverse effects registered during induction of labour

    Measured: 12 months

  2. Patients satisfaction

    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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2019
  2. Study start10 Oct 2019
  3. Primary completion1 Nov 2020 (estimated)
  4. Study completion2 Feb 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04163744
Sponsor's protocol ID
IIBSP-CRB-2019-70
Acronym
INDOBA
Status last verified
Nov 2019
First submitted
12 Nov 2019
Last updated
15 Nov 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • WHO recommendations: Induction of labour at or beyond term. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK535795/

    PubMed 30629393

  • Chen W, Xue J, Peprah MK, Wen SW, Walker M, Gao Y, Tang Y. A systematic review and network meta-analysis comparing the use of Foley catheters, misoprostol, and dinoprostone for cervical ripening in the induction of labour. BJOG. 2016 Feb;123(3):346-54. doi: 10.1111/1471-0528.13456. Epub 2015 Nov 5.

    PubMed 26538408

  • Ten Eikelder ML, Mast K, van der Velden A, Bloemenkamp KW, Mol BW. Induction of Labor Using a Foley Catheter or Misoprostol: A Systematic Review and Meta-analysis. Obstet Gynecol Surv. 2016 Oct;71(10):620-630. doi: 10.1097/OGX.0000000000000361.

    PubMed 27770132

  • Diederen M, Gommers J, Wilkinson C, Turnbull D, Mol B. Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review. BJOG. 2018 Aug;125(9):1086-1095. doi: 10.1111/1471-0528.15047. Epub 2018 Jan 10.

    PubMed 29211328

  • Vaknin Z, Kurzweil Y, Sherman D. Foley catheter balloon vs locally applied prostaglandins for cervical ripening and labor induction: a systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Nov;203(5):418-29. doi: 10.1016/j.ajog.2010.04.038.

    PubMed 20605133

  • McMaster K, Sanchez-Ramos L, Kaunitz AM. Evaluation of a Transcervical Foley Catheter as a Source of Infection: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015 Sep;126(3):539-551. doi: 10.1097/AOG.0000000000001002.

    PubMed 26244535

Questions about this trial

What is this clinical trial studying?

An observational study of Induction of Labour, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Elisa Llurba, MD, PhD (+34935537041, ellurba@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness Vaginal delivery / caesarean section rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04163744, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.

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