Induction of Labor Affected Fetus / Newborn, Prostaglandins Causing Adverse Effects in Therapeutic Use
Conditions
Keywords
dinoprostone, Bishop score, labor induction, term pregnancy
Brief summary
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.
Detailed description
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.
Interventions
DRUGDinoprostone 0.5 MG
0.5mg dinoprostone applied intracervically
DRUGDinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly
2mg dinoprostone applied intravaginally
Sponsors
Clinical Hospital Merkur
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
two dinoprostone agents are randomly applied and compared - one in patient's cervix and the other in vagina without the patient knowing which agent is applied
Intervention model description
212 pregnant women are randomly assigned into 2 groups for application of one of two dinoprostone agents used for labor induction (intravaginal or intracervical dinoprostone)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* term pregnancies (\> 37 weeks gestation) * unfavourable cervix (Bishop score \<6) * indication for labor induction * absence of uterine contractions * reassuring cardiotocography
Exclusion criteria
* ruptured membranes * scar uterus (previous caesarean section or uterus surgery) * pregnancy complications: intrauterine growth restriction; oligohydramnios, pre-eclampsia, non-reassuring/pathological cardiotocography, cholestasis in pregnancy, diabetes mellitus, multifetal pregnancy, breech presentation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time period between beginning of labor induction to delivery | 5 days | hours (difference of 4 hours or more is considered significant) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of births within 24h of start of labor induction | 7 days | N (%) |
| number of deliveries by caesarean section or instrumental deliveries | 7 days | N (%) |
| number of uterus hyperstimulation | 7 days | N (%) |
Countries
Croatia
Outcome results
None listed