Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor

Induction of Labor Clinical Trial

Official title:

A Randomized Comparison of Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150954
• Other study ID #: Pro00001312
• Status: Completed
• Phase: Phase 4
• Start date: December 2007
• Est. completion date: March 2009

Study information

• Verified date: June 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to compare induction of labor using a foley catheter bulb with a low dose of oxytocin versus a foley catheter bulb with an increasing dose of oxytocin. A foley catheter bulb with or without oxytocin is a common method of labor induction in patients whose cervix is not significantly dilated or thinned out (effaced). Oxytocin (pitocin) is a medicine used to increase the number and strength of the womb's contractions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with a singleton pregnancy

2. Term pregnancy (> 37 weeks gestation)

3. Age = 18 years

4. Bishop score < 5

5. Contractions < 6/hr

6. Reassuring fetal heart tracing

Exclusion Criteria:

1. Rupture of membranes

2. Antepartum bleeding

3. Fetal death

4. Placenta previa or low lying placenta

5. Active genital herpes infection

6. Previous use of an induction or preinduction agent during the current pregnancy

7. EFW >4500 grams

8. Non reassuring fetal testing

9. Inability to pass foley through cervix

10. Prior cesarean section

Related Conditions & MeSH terms

• Induction of Labor

Intervention

Drug:
• pitocin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to the Second Stage of Labor	The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus.	foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)
Primary	Time to Delivery	Time from foley balloon placement until neonate delivery	foley bulb placement until delivery (during admission for delivery, up to approximately 4 days)
Secondary	Rate of Cesarean Delivery	Number of participants having a cesarean delivery	during admission for delivery, up to approximately 4 days
Secondary	Time to Active Labor	Active labor was defined as the presence of regular, painful contractions and a minimum of 2 cm cervical dilation and complete effacement in nulliparous women or a minimum of 4 cm cervical dilation in multiparous women.	during admission for delivery, up to approximately 4 days
Secondary	Time to Foley Expulsion or Removal	Time from foley balloon placement until the expulsion or removal of the foley balloon.	foley bulb placement until removal, up to 10 hours
Secondary	Incidence of Uterine Hyperstimulation	Uterine hyperstimulation (tachysystole) was defined as uterine contractions occurring greater than 12 in 20 minutes.	during admission for delivery, up to approximately 4 days
Secondary	Neonatal Outcome: Birthweight		at time of birth (0 to 1 hour)
Secondary	Neonatal Outcome: Placental Abruption	number of participants with placental abruption	during admission for delivery, up to approximately 4 days
Secondary	Neonatal Outcome: Late Fetal Heart Rate Decelerations	Late fetal heart rate decelerations were defined as a gradual decrease in the fetal heart rate associated with uterine contraction with the nadir of the deceleration occurring after the peak of the contraction.	during admission for delivery, up to approximately 4 days