Foley OR MisO for the Management of Induction

Summary

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.

Conditions

• Delivery; Prolonged

Interventions

DEVICE

Cervical Foley & Misoprostol

A cervical foley combined with misoprostol will be used to induce the patient.

DRUG

Misoprostol Alone

Misoprostol will be used alone to induce the patient

DEVICE

Cervical Foley Alone

A cervical foley alone will be used to induce the patient

DEVICE

Cervical Foley & Pitocin

A cervical foley combined with pitocin will be used to induce the patient

Sponsors & Collaborators

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Lisa D Levine, MD · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2015-06-30

Completion

2015-06-30

Countries

• United States

Study Locations