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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

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

Locations

Israel
Department of Ob/Gyn, Ha`Emek Medical Center
Afula, Israel

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Department of OB/GYN, HaEmek Medical Center
ClinicalTrials.gov Identifier:	NCT00690040 History of Changes
Other Study ID Numbers:	0007-08-EMC
Study First Received:	May 31, 2008
Last Updated:	May 18, 2011
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 May 16, 2013