Foley OR MisO for the Management of Induction

Status

Completed

Phase

Not applicable

Enrollment

491 participants (actual)

Sponsor

University of Pennsylvania · Other

Design

Randomized · Single masking

Countries

1 country

United States

Start

May 2013

Primary completion

Jun 2015

Completion

Jun 2015

First posted

6 Aug 2013 (estimated)

Last update posted

18 May 2017

Conditions

Delivery; Prolonged

The percentage of women undergoing an induction of labor (IOL) is estimated to be 20% and continues to rise. Simultaneously, the cesarean delivery (CD) rate has continued to increase (2). Induction is a known risk factor for CD. Despite numerous studies evaluating time periods to define a failed IOL, there are no guidelines or accepted definitions of when to call an IOL failed given the incremental gain in vaginal delivery when IOL is prolonged. While decreasing the CD rate is an important primary focus in obstetrics, attention must also be paid to the overall length of labor given that prolonged labor is associated with adverse maternal and neonatal outcomes. Furthermore, a prolonged labor is associated with an increase in direct hospital costs and healthcare utilization. The use of cervical ripening agents, such as vaginal prostaglandin and mechanical dilators, has been demonstrated to reduce labor time and CD rate. In addition to specific individual agents, certain dosing and regimens for IOL and active labor have been compared to evaluate whether a particular dose or regimen can decrease the length of labor and decrease the CD rate. Most of these regimens; however, focus on individual induction agents and few have compared the efficacy of using more than one agent simultaneously. Given the associated risks of prolonged labor and limited data evaluating the use of combined cervical ripening agents, our objective is to evaluate the difference in time to delivery among women who undergo an IOL with four different methods.

• Experimental

  Cervical foley & Misoprostol

  Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.

• Experimental

  Misoprostol only

  Patients randomized to this arm will receive misoprostol only to induce their labor.

• Experimental

  Cervical foley alone

  Patients randomized to this arm will receive a cervical foley to induce their labor.

• Experimental

  Cervical foley & Pitocin

  Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.

1. Time to Delivery

   Time frame · Hours between start of induction to delivery

   Registry description

   Amount of hours that pass between the start of the induction to delivery.

2. Length of Stay

   Time frame · Days between admit to hospital and discharge

   Registry description

   Total maternal length of stay as defined as days from the day the induction began to the day of discharge

3. Severe RDS

   Time frame · enrollment through neonatal discharge