Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix

HaEmek Medical Center, Israel

Status: Completed

Conditions: Induction of Labor

Treatments: Device: Foley catheter; Device: Atad catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT00690040

0007-08-EMC

Details and patient eligibility

About

The purpose of this study is to compare between single balloon catheter and double balloon catheter for ripening the cervix among pregnant with unfavorable cervix.

Enrollment: 293 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Induction of labor is indicated
• Gestational age between 24 - 42 weeks
• Singleton pregnancy
• Bishop score less than 7

Exclusion criteria

• Any contraindication for vaginal delivery

• Previous cesarean delivery

• Low lying placenta

• Rupture of membranes

• Fetal malformations incompatible with life

• intrauterine fetal death

• Amnionitis

• Genital viral infection (HIV, hepatitis C virus

  , hepatitis B virus)

• Allergy to latex

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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293 participants in 2 patient groups

1

Active Comparator group

Description:

Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)

Treatment:

Device: Foley catheter

2

Active Comparator group

Description:

Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)

Treatment:

Device: Atad catheter