A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter
Summary
Hypothesis: The induction of labor in patients with unfavorable Bishop score is a challenging obstetrical process, and may be influenced or complicated by the cervical ripening method used. We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis.
Description
We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis. The study will include 200 parturients, 100 primiparous and 100 multiparous women. We will randomize each group to induction with the foley catheter or the cervical ripening double balloon. We will compare the failure rates, cesarean section rate, infectious and other postpartum complications, especially endometritis.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Induction of Labor
Intervention
Mechanical induction of labor, Double Balloon, Foley Catheter
Location
Western Galilee Hospital
Nahariya
Israel
22100
Status
Completed
Source
Western Galilee Hospital-Nahariya
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00501033
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Balloon Dilatation
Nonoperative repair of occluded vessels, ducts, or valves by insertion of a balloon catheter. It is used, among other things, to treat varices, torn retinas, renal and biliary calculi, gastric, bronchial and rectal stenoses, and heart valves, and includes catheterization with Fogarty and Foley catheters.
Balloon Dilation
Nonoperative repair of occluded vessels, ducts, or valves by insertion of a balloon catheter. It is used, among other things, to treat varices, torn retinas, renal and biliary calculi, gastric, bronchial and rectal stenoses, and heart valves, and includes catheterization with Fogarty and Foley CATHETERS.
Ovulation Induction
Techniques for the artifical induction of ovulation, the rupture of the follicle and release of the ovum.
Catheterization, Swan-ganz
Placement of a balloon-tipped catheter into the pulmonary artery through the antecubital, subclavian, and sometimes the femoral vein. It is used to measure pulmonary artery pressure and pulmonary artery wedge pressure which reflects left atrial pressure and left ventricular end-diastolic pressure. The catheter is threaded into the right atrium, the balloon is inflated and the catheter follows the blood flow through the tricuspid valve into the right ventricle and out into the pulmonary artery.
Balloon Occlusion
Use of a balloon catheter to block the flow of blood through an artery or vein.
Clinical Trials
Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml
The rate of labor induction is rising throughout the United States for a variety of reasons. Medical conditions that lead to increased risk of prolonging the pregnancy to both mother and f...
Comparison of Foley Balloon With or Without Traction for the Cervical Ripening
We will compare the use of foley bulb catheters placed in the cervix for ripening of the cervix for labor induction, One arm will have the foley balloon placed alone in the cervix. And one...
Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix
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 of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction
The purpose of this study is to compare the efficacy of a transcervical Foley catheter with and without extra-amniotic saline infusion (EASI) for priming the cervix for labor.
The purpose of this study is to specifically investigate the efficacy of an alternative pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an adjunct to F...
PubMed Articles
Objective. The primary aim was to subjectively and objectively assess pain in women during insertion of a Foley catheter for induction of labor. A secondary aim was to assess pain during cervical ripe...
PURPOSE: To compare the outcome of induced labor at term using sequential intracervical Foley catheter with intravaginal misoprostol versus intravaginal misoprostol alone....
Foley catheter versus intra-vaginal misoprostol for induction of labor in post-term gestations.
OBJECTIVE: To investigate whether a fluid filled intra-uterine extra-amniotic Foley catheter is an effective alternative to vaginal misoprostol in inducing labor in primigravid women with post-term ge...
ABSTRACT: INTRODUCTION: Conservative treatment of a heterotopic cervical pregnancy was performed with a modification of the fixation of a Foley catheter at the level of the external cervical os, follo...
PURPOSE: During abdominal myomectomy for removal of multiple fibroids, the uterine cavity may be breached. Repair of the breach is associated with a risk of development of intrauterine adhesions. We c...
