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

Induction of Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690040
• Other study ID #: 0007-08-EMC
• Status: Completed
• Phase: N/A
• First received: May 31, 2008
• Last updated: May 18, 2011
• Start date: June 2008
• Est. completion date: December 2010

Study information

• Verified date: May 2011
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Induction of Labor

Intervention

Device:
• Foley catheter
Single balloon catheter
• Atad catheter
Double balloon catheter

Locations

Country	Name	City	State
Israel	Department of Ob/Gyn, Ha`Emek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the time duration from insertion of the catheter until delivery		At the end of the study	No
Secondary	To compare mode of delivery, catheter's side effects and woman's satisfaction between the groups		At the end of the study	Yes