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.
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.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Elisa Llurba, MD, PhD, +34935537041, ellurba@santpau.cat
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:
- Prospective cohort observational study
- Historical case-control study
- Conditions
- Induction of Labour
- 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.
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)
Safety of patient and foetus
Measured through complications and adverse effects registered during induction of labour
Measured: 12 months
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.
- First posted15 Nov 2019
- Study start10 Oct 2019
- Primary completion1 Nov 2020 (estimated)
- Study completion2 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Induction of LabourStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa Llurba, MD, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 30629393Chen 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 26538408Ten 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 27770132Diederen 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 29211328Vaknin 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 20605133McMaster 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Induction of Labour Using a Double Balloon Catheter (INDOBA)
- ClinicalTrials.gov ID
- NCT04163744
- Acronym / sponsor ID
- INDOBA / IIBSP-CRB-2019-70
- Conditions
- Induction of Labour
- Keywords
- Induction of labour, Double balloon catheter, Vaginal delivery rate, Mechanical method, in-patient, out-patient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 2 Feb 2021 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Prospective cohort observational study
- Historical case-control study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (12 listed)
- Pregnant women
- Age: ≧ 18 years
- Ability to read and understand informed consent
- Unique or multiple pregnancies (monochorionic or dichorionic twins)
- ≧37 weeks of pregnancy
Key exclusion criteria (22 listed)
- >2 foetus pregnancies
- < 37 or ≧42 weeks of pregnancy
- Prelabour rupture of membranes
- Vaginal delivery contraindication
- Breech lie
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double balloon catheterInduction of labour with double balloon catheter | Device | – |
Primary outcome
Effectiveness Vaginal delivery / caesarean section rate
Time frame: 12 months
Measure vaginal delivery and caesarean rate of induction of labour with double balloon catheter
2 secondary outcomes
Safety of patient and foetus
Time frame: 12 months
Patients satisfaction
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Results publication: PubMed 30629393WHO recommendations: Induction of labour at or beyond term. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK535795/
- Results publication: PubMed 26538408Chen 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.
- Results publication: PubMed 27770132Ten 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.
- Results publication: PubMed 29211328Diederen 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.
- Results publication: PubMed 20605133Vaknin 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.
- Results publication: PubMed 26244535McMaster 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa Llurba, MD, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 7 Nov 2026.