Foley OR MisO for the Management of Induction

Completed · Not applicable

Conditions studied: Delivery; Prolonged

In brief

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.

Key facts

Study ID

NCT01916681

Run by

University of Pennsylvania

People needed

491

Starts

2013-05-01

Expected to finish

2015-06-01

Last updated by the study team

2017-05-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• All women 18 years of age or greater
• singleton gestation
• vertex presentation
• 37 weeks gestational age or greater
• undergoing an IOL
• bishop score less than or equal to 6
• cervical dilation less than or equal to 2cm

You may not qualify if…

• All women less than 18 years of age
• Contraindication for vaginal delivery
• Prior cesarean delivery
• Multiple gestation
• Intrauterine fetal demise
• Fetal anomaly
• HIV
• Unable to consent/ non-English speaking
• Non-reassuring fetal heart rate
• Patients with hemolysis elevated liver enzymes and low platelets
• Eclampsia
• Intrauterine growth restriction (IUGR) 5th percentile with abnormal dopplers
• IUGR less than 10th percentile with reversed end diastolic flow
• Recurrent late decelerations w
• Continuous contractions more than 3 times in 10 minutes at onset of IOL (given that this is a contraindication to misoprostol use at our institution)
• Bishop score is greater than 6
• Cervical dilation greater than or equal to 2cm
• Confirmed ruptured membranes

Where it is running

• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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