Clinical trial NCT00442663: Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction
Official title: Randomized Trial of Transcervical Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Induction
Cervical Ripening
Keywords: Labor Induction
Cervical Ripening
Foley Catheter
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2007-03-02
Enrollment: 170
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* 24-42 weeks of gestation
* Cephalic presentation
* Intact membranes
* Bishop score of less than or equal to 6

Exclusion Criteria:

* Contraindications to labor
* Dead or severely anomalous fetus
* Spontaneous labor.

Primary outcomes:
measure: Time from the start of labor induction to delivery
Secondary outcomes:
measure: Secondary maternal outcomes included cesarean delivery, chorioamnionitis and endometritis. Neonatal outcomes included birthweight, Apgar scores and cord blood gas analysis
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Kansas City
country: United States
facility: Truman Medical Center
state: Kansas
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Kansas
city: Greenville
country: United States
facility: Greenville Hospital System, University Medical Center
state: South Carolina
Study officials:
affiliation: University of Alabama at Birmingham
name: Monique G Lin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Obstetrix Medical Group of Kansas City
name: George Lu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Patrick S Ramsey, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guinn DA, Davies JK, Jones RO, Sullivan L, Wolf D. Labor induction in women with an unfavorable Bishop score: randomized controlled trial of intrauterine Foley catheter with concurrent oxytocin infusion versus Foley catheter with extra-amniotic saline infusion with concurrent oxytocin infusion. Am J Obstet Gynecol. 2004 Jul;191(1):225-9. doi: 10.1016/j.ajog.2003.12.039.
citation: Karjane NW, Brock EL, Walsh SW. Induction of labor using a foley balloon, with and without extra-amniotic saline infusion. Obstet Gynecol. 2006 Feb;107(2 Pt 1):234-9. doi: 10.1097/01.AOG.0000198629.44186.c8.
citation: Lin MG, Reid KJ, Treaster MR, Nuthalapaty FS, Ramsey PS, Lu GC. Transcervical Foley catheter with and without extraamniotic saline infusion for labor induction: a randomized controlled trial. Obstet Gynecol. 2007 Sep;110(3):558-65. doi: 10.1097/01.AOG.0000278077.30890.87.