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

NCT ID: NCT02932319

Last Updated: 2020-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-31

Study Completion Date

2019-10-23

Brief Summary

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

Detailed Description

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Conditions

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Induction of Labour Prolonged Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Foley catheter

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

Group Type ACTIVE_COMPARATOR

Foley catheter

Intervention Type DEVICE

The Foley cathter will be inserted at term + 4 days for 24 hours.

Expectative

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

Group Type SHAM_COMPARATOR

expectative

Intervention Type OTHER

expectative until the next day befor starting the induction

Interventions

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Foley catheter

The Foley cathter will be inserted at term + 4 days for 24 hours.

Intervention Type DEVICE

expectative

expectative until the next day befor starting the induction

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Garabedian, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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CHU de Caen

Caen, , France

Site Status

Hôpital Jeanne de Flandre - CHRU

Lille, , France

Site Status

CH Roubaix

Roubaix, , France

Site Status

CHU Rouen

Rouen, , France

Site Status

Ch Valenciennes

Valenciennes, , France

Site Status

Countries

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France

References

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Garabedian C, Tillouche N, Drumez E, Labreuche J, Dreyfus M, Deruelle P. Outpatient balloon catheter versus expectant management for post-term labor induction in nulliparous women: A randomized trial. J Gynecol Obstet Hum Reprod. 2024 Nov;53(9):102822. doi: 10.1016/j.jogoh.2024.102822. Epub 2024 Jul 10.

Reference Type DERIVED
PMID: 38997091 (View on PubMed)

Other Identifiers

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2015-A01298-41

Identifier Type: OTHER

Identifier Source: secondary_id

PHRCI_2014

Identifier Type: OTHER

Identifier Source: secondary_id

2015_10

Identifier Type: -

Identifier Source: org_study_id

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