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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter) |
|
| 2 | Active Comparator | Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foley catheter | Device | Single balloon catheter |
| |
| Atad catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Average Time in Hours From Insertion of the Catheter Until Delivery | At the end of the study |
| Measure | Description | Time Frame |
|---|---|---|
| To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups | At the end of the study |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Raed Salim, MD | Department of Ob/Gyn, Ha'Emek Medical Center, Afula, and Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ob/Gyn, Ha'Emek Medical Center | Afula | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8200466 | Background | 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. | |
| 7079521 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Balloon Catheter | Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter) |
| FG001 | Double Balloon Catheter | Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Balloon Catheter | Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter) |
| BG001 | Double Balloon Catheter | Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Time in Hours From Insertion of the Catheter Until Delivery | Posted | Mean | Standard Deviation | HOURS | At the end of the study |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Balloon Catheter | Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter) |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Raed Salim | Hemek Medical center | 97246494031 | salim_ra@clalit.org.il |
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| Device |
Double balloon catheter |
|
| 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. |
| 9914578 | Background | 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. |
| 7705527 | Background | 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. |
| 7856707 | Background | 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. |
| 15762966 | Background | 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. |
| 1984215 | Background | 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. |
| 36996264 | Derived | de 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. |
| 21691166 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups | Not Posted | At the end of the study |
| 0 |
| 145 |
| 0 |
| 145 |
| EG001 | Double Balloon Catheter | Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter) | 0 | 148 | 0 | 148 |
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