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Sponsored by: |
University of Alabama at Birmingham |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00442663 |
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.
Condition | Intervention |
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Labor Induction Cervical Ripening |
Device: Transcervical Foley Catheter Device: Transcervical Foley Catheter with an EASI |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Randomized Trial of Transcervical Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction |
Estimated Enrollment: | 170 |
Study Start Date: | June 2003 |
Study Completion Date: | December 2005 |
In the United States, labor inductions have increased from 11% of all pregnancies in 1989 to 21% in 2004. Although the indications for labor induction vary, labor inductions as an obstetrical practice are associated with an increased risk of Cesarean delivery. As such, the rise in labor inductions has been paralleled by a rise in the cesarean rate to an all time high of 30%. The risk of cesarean can be mitigated with the use of cervical ripening agents in the setting of an unfavorable cervix. Both pharmacological ripening agents and mechanical methods are currently available for cervical priming. Methods available for mechanical dilation include, but are not limited to transcervical foley catheter alone and transcervical foley catheter with an extra-amniotic saline infusion or EASI. The potential advantage of EASI to transcervical foley catheter alone is the promotion of endogenous prostaglandin release by membrane stripping and supplying additional mechanical force. It may be disadvantageous by increasing the risk of chorioamnionitis or by diluting the prostaglandins that are released by membrane stripping. There have been two randomized trials comparing foley alone to foley with EASI. Because the results of these two trials are conflicting, we chose to conduct a randomized clinical trial of foley catheter compared to foley catheter with an EASI for labor induction and cervical ripening in women with an unfavorable cervix.
Ages Eligible for Study: | 15 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35249 | |
United States, Kansas | |
Saint Luke's Hospital | |
Kansas City, Kansas, United States, 64111 | |
Truman Medical Center | |
Kansas City, Kansas, United States, 64108 | |
United States, South Carolina | |
Greenville Hospital System, University Medical Center | |
Greenville, South Carolina, United States, 29605 |
Principal Investigator: | Monique G Lin, MD | University of Alabama at Birmingham |
Principal Investigator: | George Lu, MD | Obstetrix Medical Group of Kansas City |
Principal Investigator: | Patrick S Ramsey, MD, MSPH | University of Alabama at Birmingham |
Study ID Numbers: | F050629003 |
Study First Received: | February 28, 2007 |
Last Updated: | April 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00442663 |
Health Authority: | United States: Institutional Review Board |
Labor Induction Cervical Ripening Foley Catheter |