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Outpatient Foley Cervix Priming

NCT02842879 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-07-25

No results posted yet for this study

Summary

The aim was to conduct a non-blinded prospective randomized study at a tertiary hospital. Inclusion criteria: term pregnancy with a single fetus in cephalic presentation, Bishop score \< 6, gestational age \> 41 weeks or medical indication for induction of labor.

Patients will be randomized to outpatient or inpatient cervix priming with Foley catheter.

The primary outcome will be to compare the variation of Bishop score (difference between Bishop score before and after application of Foley catheter) between outpatient and inpatient groups. Secondary comparisons include: mode of delivery, Foley catheter application-to-delivery time, inpatient time, sequential use of prostaglandins, infection and maternal pain.

Conditions

  • Outpatient Mechanical Cervix Priming

Interventions

OTHER

Outpatient Foley cervix priming

Outpatient setting for cervix priming with Foley catheter

Sponsors & Collaborators

  • Hospital de Santa Maria, Portugal

    lead OTHER

Principal Investigators

  • Catarina Policiano, MD · Hospital de Santa Maria, Centro Hospitalar Lisboa Norte

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-12-31
Completion
2015-12-31

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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 NCT02842879 on ClinicalTrials.gov