Induction of Birth
Conditions
Brief summary
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.
Interventions
DEVICEFoley Catheter
Foley Catheter 16-19 H
DEVICEDouble Balloon Catheter
Double Balloon Catheter for 16-19H
Sponsors
Haukeland University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Singleton pregnancy above week 37 * Indication to induce birth * Unripe cervix * Term date set by US before week 21
Exclusion criteria
* Ripe cervix * Prematurity (\<37w) * IUFD * Letal malformations * Low lying placenta * Multiple pregnancies * Breakage of amniotic fluid * The woman does not understand norwegian
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervix dilatation >= 3cm | At cather removal | Cervix dilatation is assessed by vaginally examination at Catheter removal. |
Countries
Norway
Outcome results
None listed