Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction (FOLEYEASI)

The University of Alabama at Birmingham

Status: Completed

Conditions: Cervical Ripening; Labor Induction

Treatments: Device: Transcervical Foley Catheter with an EASI; Device: Transcervical Foley Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT00442663

F050629003

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 15 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)