Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix
1 other identifier
interventional
293
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedFirst Posted
Study publicly available on registry
June 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
October 24, 2016
CompletedOctober 24, 2016
May 1, 2013
2.5 years
May 31, 2008
March 19, 2013
September 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average Time in Hours From Insertion of the Catheter Until Delivery
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
At the end of the study
Study Arms (2)
1
ACTIVE COMPARATORRipening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
2
ACTIVE COMPARATORRipening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
Interventions
Eligibility Criteria
You may qualify if:
- Induction of labor is indicated
- Gestational age between 24 - 42 weeks
- Singleton pregnancy
- Bishop score less than 7
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Ob/Gyn, Ha'Emek Medical Center
Afula, Israel
Related Publications (9)
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.
PMID: 8200466BACKGROUNDManabe 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.
PMID: 7079521BACKGROUNDSciscione 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.
PMID: 9914578BACKGROUNDJames 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.
PMID: 7705527BACKGROUNDSt 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.
PMID: 7856707BACKGROUNDDalui 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.
PMID: 15762966BACKGROUNDAtad 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.
PMID: 1984215BACKGROUNDde 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.
PMID: 36996264DERIVEDSalim 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.
PMID: 21691166DERIVED
Limitations and Caveats
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.
Results Point of Contact
- Title
- Dr. Raed Salim
- Organization
- Hemek Medical center
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 31, 2008
First Posted
June 4, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
October 24, 2016
Results First Posted
October 24, 2016
Record last verified: 2013-05