NCT03928600

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Centro Hospitalar De São João, E.P.E. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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-

Conditions

• Labor, Induced
• Cervical Ripening

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Cervical Foley combined with Misoprostol	Placement of cervical Foley catheter along with application of vaginal misoprostol 25ug that will be repeated 4/4h until 150ug
DRUG	Dinoprostone 10mg insert OR	Application for 24h of Dinoprostone 10mg insert
DRUG	Misoprostol	Application of vaginal misoprostol 25ug 4/4h until 150ug

Timeline

• Start date: 2018-02-01
• Primary completion: 2020-01-31
• Completion: 2020-02-29
• First posted: 2019-04-26
• Last updated: 2023-01-23

Locations

1 site across 1 country: Portugal