Labor Induction With a Combined Method (Pharmacologic and Mechanical): Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Labor, Induced; Cervical Ripening
• Interventions: Combination Product: Cervical Foley combined with Misoprostol; Drug: Dinoprostone 10mg insert OR; Drug: Misoprostol

• Registration Number: NCT03928600
• Lead Sponsor: Centro Hospitalar De São João, E.P.E.

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-

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-26
• Primary Completion: 2020-01-31
• Study Completion: 2020-02-29
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined method induction group	Cervical Foley combined with Misoprostol	* 25 micrograms misoprostol vaginal applied placed along with cervical Foley (team will repeat misoprostol application each 4 hours till 6 doses of misoprostol) * After 4 hours of last misoprostol initiate oxytocin. * Cervical Foley will be removed after 12h of placement or when fails out.
Current department guidelines group	Dinoprostone 10mg insert OR	* Following current department guidelines, as usual, with the method considered more suitable. * If they opted for vaginal misoprostol, team will insert 25micrograms, repeat application 4/4h, until 150micrograms, after last misoprostol, wait 4 hours before initiating oxytocin. * If option is vaginal dinoprostone the insert of 10mg is removed after 24h in place.
Current department guidelines group	Misoprostol	* Following current department guidelines, as usual, with the method considered more suitable. * If they opted for vaginal misoprostol, team will insert 25micrograms, repeat application 4/4h, until 150micrograms, after last misoprostol, wait 4 hours before initiating oxytocin. * If option is vaginal dinoprostone the insert of 10mg is removed after 24h in place.

Primary Outcome Measures

Name	Time	Method
Time to delivery	3 days	Time to delivery

Secondary Outcome Measures

Name	Time	Method
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
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
mean of maternal length of stay	average 3 days	induction to discharge
cesarean delivery rate	3 days	cesarean delivery rate

Trial Locations

Locations (1)

Centro Hospitalar São João; 🇵🇹 Porto, Portugal