Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy (FOLOUT)

September 9, 2020 updated by: University Hospital, Lille
15 to 20 % of nulliparous needs an induction at term. None study has evaluated Foley catheter induction at home versus expectative in this population

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France
        • CHU de Caen
      • Lille, France
        • Hôpital Jeanne de Flandre - CHRU
      • Roubaix, France
        • CH Roubaix
      • Rouen, France
        • CHU Rouen
      • Valenciennes, France
        • Ch Valenciennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • prolonged pregnancy (D+4) nulliparous no complication during pregnancy location near th hospital (20 mn by car) Bishop < 6

Exclusion Criteria:

  • medical history small for gestationnal age PROM Live alone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Foley catheter
The patient will have an induction at home after 60 mn of fetal heart rate monitoring.
Device: Foley catheter
The Foley cathter will be inserted at term + 4 days for 24 hours.
SHAM_COMPARATOR: Expectative
The patient in this arm will have the actual care (expectative until the next day befor starting the induction)
Other: expectative
expectative until the next day befor starting the induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bishop score
Time Frame: at term birth +5 days
Measure the evolution of Bishop score,change between the randomization and the return of the patient
at term birth +5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Labour ward
Time Frame: at term birth +5 days
at term birth +5 days
Total dose of prostaglandin used in case of cervical ripening.
Time Frame: During labor
During labor
Utilization rate of oxytocin
Time Frame: During labor
During labor
Total dose of Ocytocin used or not for induction labor
Time Frame: During labor
During labor
number of birth
Time Frame: between the term consultation + 4 days (randomization) and delivery time
between the term consultation + 4 days (randomization) and delivery time
delivery rate
Time Frame: within 24 hours and 48 hours after randomization
within 24 hours and 48 hours after randomization
Caesarean rate
Time Frame: before labor and during labor
before labor and during labor
Maternal complications
Time Frame: through study completion, at 4 day
It's the time between the term consultation + 4 days (randomization) and delivery time (day 4)
through study completion, at 4 day
Fetal complications
Time Frame: through study completion, at 4 day
through study completion, at 4 day
Neonatal complications
Time Frame: through study completion, at 4 day
through study completion, at 4 day
Duration of hospital stay
Time Frame: through study completion, at 4 day
through study completion, at 4 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Charles Garabedian, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 31, 2017

Primary Completion (ACTUAL)

October 23, 2019

Study Completion (ACTUAL)

October 23, 2019

Study Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (ESTIMATE)

October 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015_10
  • PHRCI_2014 (OTHER: PHRC number, DGOS)
  • 2015-A01298-41 (OTHER: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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