Labor, induced
Conditions
Interventions
This is a randomized clinical trial with 4 open arms. Randomization will be stratified by Robson groups (1-4 and 5.1), considering nulliparous and multiparous patients, with or without a history of pr
group 2 receiving only the Foley catheter, with the possibility of using misoprostol later based on cervical conditions
group 3 receiving Foley catheter + oxytocin simultaneously
and group 4 receiving Foley catheter followed by oxytocin after removal of the Foley catheter. The sample size of 492 patients was estimated to compare the four induction methods, with groups of equal
Sponsors
Hospital da Mulher Professor Doutor José Aristodemo Pinotti da Universidade Estadual de Campinas
Universidade Estadual de Campinas
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women above 18 years old; nulliparous and multiparous women; gestational age of 37 weeks or more; single pregnancy; cephalic presentation; intact membranes; bishop score of 6 or less; and cervical dilation of 2 centimeters or less
Exclusion criteria
Exclusion criteria: Patients who have any contraindication to vaginal birth; category 3 fetal heart rate tracking; presence of hemolysis; elevated liver enzymes and low platelet syndrome (HELLP); eclampsia; growth restriction below the 10th percentile (Hadlock growth curves) with reversed flow in doppler studies of the umbilical artery; restriction below the 5th percentile with elevated, absent, or reversed flow on doppler studies of the umbilical artery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that labor induction using combined methods will be associated with a shorter time between the start of induction and delivery, as well as a higher success rate for vaginal delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the rate of vaginal deliveries between the groups receiving combined parallel intervention versus serial intervention;Expand knowledge on labor induction and the factors associated with the success and satisfaction of the procedure | — |
Countries
Brazil
Contacts
Public ContactAdriana Luz
Universidade Estadual de Campinas
Outcome results
None listed