Cervical Ripening, Labor, Induced
Conditions
Keywords
induction of labor, cervical ripening, combined methods
Brief summary
Labor induction is a common pregnancy procedure worldwide. Both mechanical and pharmacologic agents are used for induction of labor. These agents reduce the incidence of cesarean delivery in women undergoing induction. Opposite to old studies of cervical ripening, some recent studies have shown promise in reducing labor time and risk of cesarean delivery with combination methods. The effectiveness of this procedure is of major clinical importance and has a large impact in our quotidian practice. The objective is to compare the effectiveness of a combined new method to current guidelines of our department
Detailed description
We designed a randomized trial that will compare two groups: misoprostol-cervical Foley simultaneously and the current department guidelines (misoprostol alone/dinoprostone alone). Inclusion criteria: full-term (≥ 37 weeks of gestation), singleton, vertex-
Interventions
COMBINATION_PRODUCTCervical Foley combined with Misoprostol
Placement of cervical Foley catheter along with application of vaginal misoprostol 25ug that will be repeated 4/4h until 150ug
DRUGDinoprostone 10mg insert OR
Application for 24h of Dinoprostone 10mg insert
DRUGMisoprostol
Application of vaginal misoprostol 25ug 4/4h until 150ug
Sponsors
Centro Hospitalar De São João, E.P.E.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* full-term (≥ 37 weeks of gestation) * singleton * vertex-presenting gestations * with no contraindication to vaginal delivery * intact membranes * Bishop score \< 7 and cervical dilation ≤2 cm
Exclusion criteria
* contraindication for misoprostol * history of previous caesarean * rupture of membranes, * fetal or maternal morbidities (fetal major abnormalities, FIGO definition of pathological CTG, HELLP syndrome, preeclampsia or hypertension with severe features, fetal growth restriction)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to delivery | 3 days | Time to delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to active labor | 3 days | defined as dilation of 6 cm or greater |
| rate of delivery within 12 hours | 12 hours | rate of delivery within 12 hours |
| rate of delivery within 24 hours | 24 hours | rate of delivery within 24 hours |
| cesarean delivery rate | 3 days | cesarean delivery rate |
| indication for cesarean delivery | 3 days | indication for cesarean delivery |
| composite maternal morbidity outcome | 6 weeks | third- or fourth-degree perineal laceration, blood transfusion, chorioamnionitis, endometritis, wound infection, venous thromboembolism, hysterectomy, intensive care unit admission or death. |
| composite of neonatal morbidities | 30 days | SDR, neonatal sepsis, blood transfusion, encephalopathy hypoxic-ischemic, intraventricular hemorrhage of grade III/IV |
| mean of maternal length of stay | average 3 days | induction to discharge |
Countries
Portugal
Outcome results
None listed