Status:
COMPLETED
The Balloon Project for Birth Induction
Lead Sponsor:
Glostrup University Hospital, Copenhagen
Conditions:
Induction Time
Apgar Score
Eligibility:
FEMALE
Phase:
PHASE4
Brief Summary
The use of prostaglandin E2 (PGE2) for induction of labour in women with unfavourable cervices is well-established1. There are, however, potential side effects to prostaglandins, in particular the ris...
Detailed Description
The study was a multicenter randomized study conducted at 7 labour yards in Denmark (Glostrup, Hillerød, Svendborg, Rigshospitalet, Næstved, Frederiksberg and Hvidovre). Participants were included fro...
Eligibility Criteria
Inclusion
- pregnancies with intact fetal membranes
- vertex position
- unripe cervix Bishop score \< 6)
- usual indications for induction of labour, i.e. prolonged pregnancy, pre-eclampsia/ hyper-tension, placental insufficiency, diabetes mellitus and twins
Exclusion
- Spontaneous labour or rupture of membranes
- placenta previa
- acute fetal distress
- specific infections vagina/cervix (GBS, condyloma, acute herpes)
- asthma
- glaucoma
- allergy to latex
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
825 Patients enrolled
Trial Details
Trial ID
NCT01255839
Start Date
December 1 2002
End Date
December 1 2010
Last Update
December 8 2010
Active Locations (1)
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1
Glostrup University Hospital
Glostrup Municipality, Glostrup, Denmark, 2600