Tension Versus no Tension With Foley Bulb Induction

Hawaii Pacific Health

Status: Enrolling

Conditions: Induction of Labor Affected Fetus / Newborn

Treatments: Procedure: Tension; Procedure: NO TENSION

Study type: Interventional

Funder types: Other

Identifiers

NCT03588585

2017-077

Details and patient eligibility

About

To compare the application of tension versus no tension in Foley transcervical catheters for pre-induction cervical ripening.

Full description

Patients who are scheduled to undergo labor induction will be offered inclusion in the study which will attempt to determine if placing tension on the foley ballon will shorten the interval between induction initiation and delivery.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Nulliparas with singleton live intrauterine pregnancies undergoing labor induction at Kapiolani Medical Center for Women and Children.
• Cephalic presentation
• Intact fetal membranes
• Bishop score less than or equal to 6
• Age greater than or equal to 18 years

Exclusion criteria

• Multiparas
• Multiple gestation
• Previous uterine/cervical surgery
• Ruptured fetal membranes
• Fetal malpresentation
• Any contraindication to vaginal delivery at time of admission

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

Tension

Active Comparator group

Description:

foley balloon will be placed on tension and taped to thigh at 10 cm. Misoprostil will be placed in posterior vaginal vault.

Treatment:

Procedure: Tension

No tension

Active Comparator group

Description:

The foley balloon will be loosely taped without tension to the patient's thigh. Misoprostil will be placed in the posterior vaginal vault.

Treatment:

Procedure: NO TENSION