Clinical trial NCT00690040: Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix
Official title: Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induction of Labor
Keywords: Induction of labor
Ripening
Single balloon catheter
Double balloon catheter
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2008-06-04
Enrollment: 293
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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, hepatitis C virus

  , hepatitis B virus)
* Allergy to latex

Primary outcomes:
measure: Average Time in Hours From Insertion of the Catheter Until Delivery
timeFrame: At the end of the study
Secondary outcomes:
measure: To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups
timeFrame: At the end of the study
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Department of Ob/Gyn, Ha'Emek Medical Center
Study officials:
affiliation: Department of Ob/Gyn, Ha'Emek Medical Center, Afula, and Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel
name: Raed Salim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/0090-6980(82)90052-1.
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. doi: 10.1016/s0002-9378(99)70149-3.
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. doi: 10.1016/0020-7292(94)90566-5.
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. doi: 10.1016/0002-9378(95)90594-4.
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. doi: 10.1111/j.0001-6349.2005.00662.x.
citation: 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.
citation: 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.