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

NCT03928600 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-01-23

No results posted yet for this study

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

Conditions

  • Labor, Induced
  • Cervical Ripening

Interventions

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

Sponsors & Collaborators

  • Centro Hospitalar De São João, E.P.E.

    lead OTHER

Principal Investigators

  • Rita P Valente, MD · Centro Hospitalar São João, Porto

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2020-01-31
Completion
2020-02-29

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03928600 on ClinicalTrials.gov