Cervical Foley Plus Vaginal Misoprostol for Labor Induction

Induction of Labor Clinical Trial

Official title:

Cervical Foley Plus Vaginal Misoprostol Versus Vaginal Misoprostol for Cervical Ripening and Labor Induction: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279343
• Other study ID #: 10-1135-201107249
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: March 2014

Study information

• Verified date: May 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy of the combination of the supracervical foley bulb and vaginal misoprostol to vaginal misoprostol alone for labor induction. We hypothesize that use of the foley bulb plus vaginal misoprostol will result in shorter induction to delivery time.

Description:

More than 22% of all gravid women undergo induction of labor in the United States for various indications. Although there are several techniques and methods for induction of labor, the best agent and method still remains uncertain. To date, there has been no randomized trial comparing foley bulb plus vaginal misoprostol versus vaginal misoprostol alone. The combination of a mechanical device (foley bulb) and synthetic prostaglandin may have an additive or synergistic effect, resulting in greater degree of cervical ripening and shorter induction to delivery time (IDT). The addition of a synthetic prostaglandin to the foley bulb may also overcome the frequent observation of cervical dilation to 4cm by the foley bulb without effacement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

Inclusion Criteria:

• singleton pregnancy

• vertex presentation

• unfavorable cervix(Bishop's score less than or equal to 6)

• greater than 24 weeks gestation

Exclusion Criteria:

• fetal malpresentation

• multifetal gestation

• spontaneous labor

• more than 5 uterine contractions in 10 minutes

• contraindication to prostaglandins

• non-reassuring fetal heart rate tracing

• intrauterine growth restriction

• anomalous fetus

• fetal demise

• previous cesarean delivery or other significant uterine surgery

Related Conditions & MeSH terms

• Induction of Labor

Intervention

Device:
• Foley bulb
This is a randomized trial comparing foley bulb with the use of misoprostol versus use of misoprostol alone for cervical ripening and labor induction.

Locations

Country	Name	City	State
United States	Barnes Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time From Start of Labor Induction to Vaginal Delivery		72 hours
Secondary	Successful Number of Vaginal and Cesarean Deliveries	To compare the number of vaginal deliveries to failed inductions requiring cesarean deliveries.	72 hours
Secondary	Number of Participants Experiencing Tachysystole With Deceleration		72 hours
Secondary	Number of Participants With Post-partum Hemorrhage		96 hours
Secondary	Chorioamnionitis		96 hours
Secondary	Neonatal APGAR Scores	APGAR scores will be recorded at 1 and 5 minutes after birth. In the test, five things are used to check a baby's health. Each is scored on a scale of 0 to 2, with 2 being the best score: Appearance (skin color) Pulse (heart rate) Grimace response (reflexes) Activity (muscle tone) Respiration (breathing rate and effort)	5 minutes
Secondary	NICU Admission		96 hours
Secondary	Time to Complete Cervical Dilation	We will record the start time of induction until the patient's cervix is 10cm dilated	72 hours
Secondary	Delivery Within 24 Hours		Delivery within 24 hours of induction
Secondary	Admission to NICU or Special Care Nursery		birth to 96 hours of age