Scarred UterusNCT01711060
A Comparison of Balloon Catheter Versus Ocytocin for Cervical Ripening on Scarred Uterus With Unfavorable Cervix
A study testing oxytocin and balloon catheter in people with Scarred Uterus, run by Poitiers University Hospital at 7 sites in France.
Trial summary
Increasing cesarean rate in France is worrying. Different methods are described for ripening labor : the use of prostaglandins is described but maybe dangerous for patients with scarred uterus and is not recommended. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Scarred Uterus
- What is being tested?
- oxytocin and balloon catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 7 sitesFrance
- Study dates
- Dec 2010to Jan 2014
- Phase
- Interventional
- 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 to 45 years
- Women only
- Adult
Who may be able to join
- Pregnancy over 37 weeks
- Singleton pregnancy
- Vertex presentation
- Previous caesarean section with unique Transversal segmentary incision
- Medical indication of induction of labor
- Unfavorable cervix with Bishop score < 4
- No Premature Rupture Of Membranes
- Informed consent
Who cannot join
- Before 18 years old
- Placenta Praevia
- Premature Rupture Of Membranes
- Uterine scar other than transversal segmentary incision
- Cervical infection (except Streptoccoccus Agalactiae carrier) or choriamnionitis
- Multiple pregnancy
Show all 10Show fewer
- Fetal malpresentation
- Cesarean indication
- Latex allergy
- No informed consent
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Service Gynécologie Obstétrique
Angoulême
Service Gynécologie Obstétrique
Bressuire
Service Gynécologie Obstétrique
Châtellerault
Service Gynécologie Obstétrique
Nancy
Service Gynécologie Obstétrique et médecine de la reproduction
Poitiers, 86021
Service Gynécologie Obstétrique
Rennes
Service Gynécologie Obstétrique
Toulouse
About this study
Increasing cesarean rate in France is worrying. Different methods are described for ripening labor : the use of prostaglandins is described but maybe dangerous for patients with scarred uterus and is not recommended.
Intracervical balloon is an efficient alternative methods which as already been tested for unfavorable cervix ripening on nulliparous women.
Read more
But it was rarely tested on women with scared uterus and unfavorable cervix (bishop score <4).
The investigators propose a prospective randomised trial comparing cervix ripening with intracervical balloon inflated by 50 ml sterile water during 12 hours versus ocytocin (reference method).
The investigators expect to demonstrate what it's a safe method to increase vaginal delivery for women with previous cesarean section who need an induction of labour.
- Conditions
- Scarred Uterus
- Being tested
- oxytocin, balloon catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocinDrug
balloon catheterProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| oxytocin | Experimental | Not described Receives: Drug: oxytocin |
| balloon catheter | Experimental | Dufour 1859H18 Receives: Procedure: balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of childbirth by low way
The childbirth by low way being considered as a success of the treatment
Secondary outcomes (1)
Rate of incidence of materno-fœtales morbidity
number
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startDec 2010
- Primary completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scarred UterusStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711060
- Sponsor's protocol ID
- CICATAC
- Status last verified
- Oct 2016
- First submitted
- 23 Aug 2012
- Last updated
- 11 Oct 2016
- Results posted
- No
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Balloon Catheter Versus Ocytocin for Cervical Ripening on Scarred Uterus With Unfavorable Cervix
- ClinicalTrials.gov ID
- NCT01711060
- Acronym / sponsor ID
- CICATAC
- Conditions
- Scarred Uterus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jan 2014 (actual)
- First posted
- 22 Oct 2012 (estimated)
- 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.
Increasing cesarean rate in France is worrying. Different methods are described for ripening labor : the use of prostaglandins is described but maybe dangerous for patients with scarred uterus and is not recommended.
Intracervical balloon is an efficient alternative methods which as already been tested for unfavorable cervix ripening on nulliparous women.
But it was rarely tested on women with scared uterus and unfavorable cervix (bishop score <4).
The investigators propose a prospective randomised trial comparing cervix ripening with intracervical balloon inflated by 50 ml sterile water during 12 hours versus ocytocin (reference method).
The investigators expect to demonstrate what it's a safe method to increase vaginal delivery for women with previous cesarean section who need an induction of labour.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin | Experimental | Drug: oxytocin |
| balloon catheter | Experimental | Procedure: balloon catheterDufour 1859H18 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Pregnancy over 37 weeks
- Singleton pregnancy
- Vertex presentation
- Previous caesarean section with unique Transversal segmentary incision
- Medical indication of induction of labor
Key exclusion criteria (10 listed)
- Before 18 years old
- Placenta Praevia
- Premature Rupture Of Membranes
- Uterine scar other than transversal segmentary incision
- Cervical infection (except Streptoccoccus Agalactiae carrier) or choriamnionitis
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 |
|---|---|---|
| oxytocin | Drug | oxytocin |
| balloon catheter | Procedure or surgery | balloon catheter |
Primary outcome
Rate of childbirth by low way
The childbirth by low way being considered as a success of the treatment
1 secondary outcome
Rate of incidence of materno-fœtales morbidity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxytocin and balloon catheter in people with Scarred Uterus, run by Poitiers University Hospital at 7 sites in France.
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 8 inclusion and 10 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: finished, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of childbirth by low way. 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 NCT01711060, which also lists 1 linked publication.
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 11 Oct 2016.