Induction of Birth Clinical Trial
Official title:
Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study
A randomized controlled double blinded study to investigate whether a specially designed
double balloon catheter is more efficient than a foley catheter for cervical ripening and
induction of birth.
160 women with singleton term pregnancies with un ripe cervix and no contraindications for
catheters will be included and randomized to either double og single balloon catheters for
cervical ripening. Efficacy wil be assessed at removal of the catheter, measured by the
amount of women where the cervix has become ripe enough for amniotomy.
Our hypothesis is that double balloon catheters will give a greater amount of women where
amniotomy upon catheter removal is possible. Secondary outcomes as time from induction till
birth, vaginal deliveries and complications during or after birth for the mother or child
will also become recorded.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment