This is a prospective randomized trial comparing two prostaglandin E2 (dinoprostone) agents used for labor induction in pregnant women with term pregnancies and unfavorable cervix.
This prospective randomized trial includes pregnant women with term pregnancies, indication for labor induction and an unfavorable cervix. These women are randomized into two groups: one group is induced using an intracervical prostaglandin E2 (PGE2, dinoprostone) formulation, the other using an intravaginal PGE2 formulation. Main outcome is time period between beginning of labor induction to delivery, and a reduction of four hours is considered clinically significant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
212
0.5mg dinoprostone applied intracervically
2mg dinoprostone applied intravaginally
Clinical Hospital Merkur
Zagreb, Croatia
time period between beginning of labor induction to delivery
hours (difference of 4 hours or more is considered significant)
Time frame: 5 days
number of births within 24h of start of labor induction
N (%)
Time frame: 7 days
number of deliveries by caesarean section or instrumental deliveries
N (%)
Time frame: 7 days
number of uterus hyperstimulation
N (%)
Time frame: 7 days
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