Induction of LaborNCT00690040

Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix

A study testing Foley catheter and Atad catheter in people with Induction of Labor, run by HaEmek Medical Center, Israel at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare between single balloon catheter and double balloon catheter for ripening the cervix among pregnant with unfavorable cervix. Read more about this study

Who is it for?: Ages 18 to 48 years, women only
Conditions the study is for: Induction of Labor
What is being tested?: Foley catheter and Atad catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 293 participants
Where: 1 siteIsrael
Study dates: Jun 2008to Dec 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 48 years
Women only
No healthy volunteers
Adult

Who may be able to join

Induction of labor is indicated
Gestational age between 24 - 42 weeks
Singleton pregnancy
Bishop score less than 7

Who cannot join

Any contraindication for vaginal delivery
Previous cesarean delivery
Low lying placenta
Rupture of membranes
Fetal malformations incompatible with life
intrauterine fetal death

Show all 10Show fewer

Amnionitis
Genital viral infection (HIV, hepatitis C virus
, hepatitis B virus)
Allergy to latex

Trial locations and contacts

1 site in 1 country.

Israel1 site

Department of Ob/Gyn, Ha'Emek Medical Center
Afula

Other trials in Israel

About this study

The purpose of this study is to compare between single balloon catheter and double balloon catheter for ripening the cervix among pregnant with unfavorable cervix.

Conditions: Induction of Labor
Being tested: Foley catheter, Atad catheter
Keywords: Induction of labor, Ripening, Single balloon catheter, Double balloon catheter

What participants receive

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

Foley catheterDevice
Single balloon catheter
Atad catheterDevice
Double balloon catheter

Study groups in NCT00690040
Study group	Role	What they receive
1	Active comparator	Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter) Receives: Device: Foley catheter
2	Active comparator	Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter) Receives: Device: Atad catheter

What is being measured

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

Average Time in Hours From Insertion of the Catheter Until Delivery
Measured: At the end of the study

Secondary outcomes (1)

To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups
Measured: At the end of the study

Timeline

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

Jun 2008Dec 2010

First posted4 Jun 2008 (estimated)
Study startJun 2008
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Induction of LaborStudies of the same condition, open and under way.
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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 293 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00690040
Sponsor's protocol ID: 0007-08-EMC
Status last verified: May 2013
First submitted: 31 May 2008
Last updated: 24 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lyndrup J, Nickelsen C, Weber T, Molnitz E, Guldbaek E. Induction of labour by balloon catheter with extra-amniotic saline infusion (BCEAS): a randomised comparison with PGE2 vaginal pessaries. Eur J Obstet Gynecol Reprod Biol. 1994 Mar 15;53(3):189-97. doi: 10.1016/0028-2243(94)90118-x.
PubMed 8200466
Manabe Y, Manabe A, Takahashi A. F prostaglandin levels in amniotic fluid during balloon-induced cervical softening and labor at term. Prostaglandins. 1982 Feb;23(2):247-56. doi: 10.1016/0090-6980(82)90052-1.
PubMed 7079521
Sciscione AC, McCullough H, Manley JS, Shlossman PA, Pollock M, Colmorgen GH. A prospective, randomized comparison of Foley catheter insertion versus intracervical prostaglandin E2 gel for preinduction cervical ripening. Am J Obstet Gynecol. 1999 Jan;180(1 Pt 1):55-60. doi: 10.1016/s0002-9378(99)70149-3.
PubMed 9914578
James C, Peedicayil A, Seshadri L. Use of the Foley catheter as a cervical ripening agent prior to induction of labor. Int J Gynaecol Obstet. 1994 Dec;47(3):229-32. doi: 10.1016/0020-7292(94)90566-5.
PubMed 7705527
St Onge RD, Connors GT. Preinduction cervical ripening: a comparison of intracervical prostaglandin E2 gel versus the Foley catheter. Am J Obstet Gynecol. 1995 Feb;172(2 Pt 1):687-90. doi: 10.1016/0002-9378(95)90594-4.
PubMed 7856707
Dalui R, Suri V, Ray P, Gupta I. Comparison of extraamniotic Foley catheter and intracervical prostaglandin E gel for preinduction cervical ripening. Acta Obstet Gynecol Scand. 2005 Apr;84(4):362-7. doi: 10.1111/j.0001-6349.2005.00662.x.
PubMed 15762966
Atad J, Bornstein J, Calderon I, Petrikovsky BM, Sorokin Y, Abramovici H. Nonpharmaceutical ripening of the unfavorable cervix and induction of labor by a novel double balloon device. Obstet Gynecol. 1991 Jan;77(1):146-52.
PubMed 1984215
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
Salim R, Zafran N, Nachum Z, Garmi G, Kraiem N, Shalev E. Single-balloon compared with double-balloon catheters for induction of labor: a randomized controlled trial. Obstet Gynecol. 2011 Jul;118(1):79-86. doi: 10.1097/AOG.0b013e318220e4b7.
PubMed 21691166

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Implementation of a Disparities in Labor Outcomes Dashboard
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Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety

All Induction of Labor trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix
ClinicalTrials.gov ID: NCT00690040
Acronym / sponsor ID: 0007-08-EMC
Conditions: Induction of Labor
Keywords: Induction of labor, Ripening, Single balloon catheter, Double balloon catheter
Study type: Interventional
Recruitment status: Completed
Enrolment: 293 participants (actual)
Lead sponsor: HaEmek Medical Center, IsraelUniversity, hospital or other
Study start: Jun 2008
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 4 Jun 2008 (estimated)
Results: Posted 24 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare between single balloon catheter and double balloon catheter for ripening the cervix among pregnant with unfavorable cervix.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Device: Foley catheterRipening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
2	Active comparator	Device: Atad catheterRipening of the unfavorable cervix is done with double balloon catheter (Atad catheter)

Who may qualify

Ages: 18 to 48 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Induction of labor is indicated
Gestational age between 24 - 42 weeks
Singleton pregnancy
Bishop score less than 7

Key exclusion criteria (10 listed)

Any contraindication for vaginal delivery
Previous cesarean delivery
Low lying placenta
Rupture of membranes
Fetal malformations incompatible with life

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
Foley catheterSingle balloon catheter	Device	1
Atad catheterDouble balloon catheter	Device	2

Primary outcome

Average Time in Hours From Insertion of the Catheter Until Delivery
Time frame: At the end of the study

1 secondary outcome

To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups
Time frame: At the end of the study

Results and safety

Results posted to the registry on 24 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Balloon Catheter	145	145
Double Balloon Catheter	148	148

Primary outcome: Average Time in Hours From Insertion of the Catheter Until Delivery

Time frame: At the end of the study. Mean (Standard Deviation). Unit: HOURS

Measure	Single Balloon Catheter n = 145	Double Balloon Catheter n = 148
Value	19.4 (6.0)	19.1 (6.8)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Balloon Catheter	0 of 145 (0%)	0 of 145 (0%)	Not reported
Double Balloon Catheter	0 of 148 (0%)	0 of 148 (0%)	Not reported

Limitations and caveats (from the sponsor): Blinding was not performed among patients and providers. However, other than the catheter type, management was standardized. Accordingly,such unblinding is not expected to affect the objectively measured outcomeS.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8200466Lyndrup J, Nickelsen C, Weber T, Molnitz E, Guldbaek E. Induction of labour by balloon catheter with extra-amniotic saline infusion (BCEAS): a randomised comparison with PGE2 vaginal pessaries. Eur J Obstet Gynecol Reprod Biol. 1994 Mar 15;53(3):189-97. doi: 10.1016/0028-2243(94)90118-x.
Background: PubMed 7079521Manabe Y, Manabe A, Takahashi A. F prostaglandin levels in amniotic fluid during balloon-induced cervical softening and labor at term. Prostaglandins. 1982 Feb;23(2):247-56. doi: 10.1016/0090-6980(82)90052-1.
Background: PubMed 9914578Sciscione AC, McCullough H, Manley JS, Shlossman PA, Pollock M, Colmorgen GH. A prospective, randomized comparison of Foley catheter insertion versus intracervical prostaglandin E2 gel for preinduction cervical ripening. Am J Obstet Gynecol. 1999 Jan;180(1 Pt 1):55-60. doi: 10.1016/s0002-9378(99)70149-3.
Background: PubMed 7705527James C, Peedicayil A, Seshadri L. Use of the Foley catheter as a cervical ripening agent prior to induction of labor. Int J Gynaecol Obstet. 1994 Dec;47(3):229-32. doi: 10.1016/0020-7292(94)90566-5.
Background: PubMed 7856707St Onge RD, Connors GT. Preinduction cervical ripening: a comparison of intracervical prostaglandin E2 gel versus the Foley catheter. Am J Obstet Gynecol. 1995 Feb;172(2 Pt 1):687-90. doi: 10.1016/0002-9378(95)90594-4.
Background: PubMed 15762966Dalui R, Suri V, Ray P, Gupta I. Comparison of extraamniotic Foley catheter and intracervical prostaglandin E gel for preinduction cervical ripening. Acta Obstet Gynecol Scand. 2005 Apr;84(4):362-7. doi: 10.1111/j.0001-6349.2005.00662.x.
Background: PubMed 1984215Atad J, Bornstein J, Calderon I, Petrikovsky BM, Sorokin Y, Abramovici H. Nonpharmaceutical ripening of the unfavorable cervix and induction of labor by a novel double balloon device. Obstet Gynecol. 1991 Jan;77(1):146-52.
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.
Derived from this study: PubMed 21691166Salim R, Zafran N, Nachum Z, Garmi G, Kraiem N, Shalev E. Single-balloon compared with double-balloon catheters for induction of labor: a randomized controlled trial. Obstet Gynecol. 2011 Jul;118(1):79-86. doi: 10.1097/AOG.0b013e318220e4b7.

Related trials for Induction of Labor

Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety

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.

Raed Salim, MD principal investigator

Department of Ob/Gyn, Ha'Emek Medical Center, Afula, and Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Foley catheter and Atad catheter in people with Induction of Labor, run by HaEmek Medical Center, Israel at 1 site in Israel.

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 4 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 24 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 1 site in Israel. 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?

Yes. Results are posted in the registry (first posted 24 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Average Time in Hours From Insertion of the Catheter Until Delivery (time frame: At the end of the study). 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 NCT00690040, which also lists 9 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 24 Oct 2016.