Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442663
Status:
COMPLETED
Last Update Posted:
2007-04-24
First Post:
2007-02-28
Brief Title:
Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Randomized Trial of Transcervical Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOLEYEASI
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None