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

Primary Purpose

Induction of Labour, Prolonged Pregnancy

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Foley catheter
expectative
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Induction of Labour focused on measuring induction of labour, nulliparous, prolonged pregnancy, foley catheter, vaginal birth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Foley catheter

Expectative

Arm Description

The patient will have an induction at home after 60 mn of fetal heart rate monitoring.

The patient in this arm will have the actual care (expectative until the next day befor starting the induction)

Outcomes

Primary Outcome Measures

Bishop score
Measure the evolution of Bishop score,change between the randomization and the return of the patient

Secondary Outcome Measures

Labour ward
Total dose of prostaglandin used in case of cervical ripening.
Utilization rate of oxytocin
Total dose of Ocytocin used or not for induction labor
number of birth
delivery rate
Caesarean rate
Maternal complications
It's the time between the term consultation + 4 days (randomization) and delivery time (day 4)
Fetal complications
Neonatal complications
Duration of hospital stay

Full Information

First Posted
October 4, 2016
Last Updated
September 9, 2020
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT02932319
Brief Title
Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy
Acronym
FOLOUT
Official Title
Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Deficient Inclusions
Study Start Date
March 31, 2017 (Actual)
Primary Completion Date
October 23, 2019 (Actual)
Study Completion Date
October 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
15 to 20 % of nulliparous needs an induction at term. None study has evaluated Foley catheter induction at home versus expectative in this population

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Induction of Labour, Prolonged Pregnancy
Keywords
induction of labour, nulliparous, prolonged pregnancy, foley catheter, vaginal birth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Foley catheter
Arm Type
Active Comparator
Arm Description
The patient will have an induction at home after 60 mn of fetal heart rate monitoring.
Arm Title
Expectative
Arm Type
Sham Comparator
Arm Description
The patient in this arm will have the actual care (expectative until the next day befor starting the induction)
Intervention Type
Device
Intervention Name(s)
Foley catheter
Intervention Description
The Foley cathter will be inserted at term + 4 days for 24 hours.
Intervention Type
Other
Intervention Name(s)
expectative
Intervention Description
expectative until the next day befor starting the induction
Primary Outcome Measure Information:
Title
Bishop score
Description
Measure the evolution of Bishop score,change between the randomization and the return of the patient
Time Frame
at term birth +5 days
Secondary Outcome Measure Information:
Title
Labour ward
Time Frame
at term birth +5 days
Title
Total dose of prostaglandin used in case of cervical ripening.
Time Frame
During labor
Title
Utilization rate of oxytocin
Time Frame
During labor
Title
Total dose of Ocytocin used or not for induction labor
Time Frame
During labor
Title
number of birth
Time Frame
between the term consultation + 4 days (randomization) and delivery time
Title
delivery rate
Time Frame
within 24 hours and 48 hours after randomization
Title
Caesarean rate
Time Frame
before labor and during labor
Title
Maternal complications
Description
It's the time between the term consultation + 4 days (randomization) and delivery time (day 4)
Time Frame
through study completion, at 4 day
Title
Fetal complications
Time Frame
through study completion, at 4 day
Title
Neonatal complications
Time Frame
through study completion, at 4 day
Title
Duration of hospital stay
Time Frame
through study completion, at 4 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Garabedian, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Caen
City
Caen
Country
France
Facility Name
Hôpital Jeanne de Flandre - CHRU
City
Lille
Country
France
Facility Name
CH Roubaix
City
Roubaix
Country
France
Facility Name
CHU Rouen
City
Rouen
Country
France
Facility Name
Ch Valenciennes
City
Valenciennes
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy

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