Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix - Full Text View

Sponsored by:	HaEmek Medical Center, Israel
Information provided by:	HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT00690040

Purpose

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.

Condition	Intervention
Induction of Labor	Device: Foley catheter Device: Atad catheter

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:

To compare the time duration from insertion of the catheter until delivery [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare mode of delivery, catheter's side effects and woman's satisfaction between the groups [ Time Frame: At the end of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	290
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)	Device: Foley catheter Single balloon catheter
2: Active Comparator Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)	Device: Atad catheter Double balloon catheter

Eligibility

Ages Eligible for Study:	18 Years to 48 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Any contraindication for vaginal delivery
Previous cesarean delivery
Low lying placenta
Rupture of membranes
Fetal malformations incompatible with life
intrauterine fetal death
Amnionitis
Genital viral infection (HIV, HCV, HBV)
Allergy to latex

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690040

Contacts

Contact: Raed Salim, MD	972-4-649-4035	salim_ra@clalit.org.il
Contact: Eliezer Shalev, MD	972-4-649-4031	shaleve@tx.technion.ac.il

Locations

Israel
Department of Ob/Gyn, Ha`Emek Medical Center	Recruiting
Afula, Israel
Principal Investigator: Raed Salim, MD

Sponsors and Collaborators

HaEmek Medical Center, Israel

Investigators

Principal Investigator:

Raed Salim, MD

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

More Information

Publications:

Lyndrup J, Nickelsen C, Weber T, Mølnitz 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.

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.

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.

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.

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.

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.

Lyndrup J, Nickelsen C, Weber T, Mølnitz 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.

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.

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.

Responsible Party:	HaEmek Medical Center ( Department of OB/GYN )
Study ID Numbers:	0007-08-EMC
Study First Received:	May 31, 2008
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00690040
Health Authority:	Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:

Induction of labor
Ripening
Single balloon catheter
Double balloon catheter

ClinicalTrials.gov processed this record on January 15, 2009