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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02932319
Recruitment Status : Terminated (Deficient Inclusions)
First Posted : October 13, 2016
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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

Condition or disease Intervention/treatment Phase
Induction of Labour Prolonged Pregnancy Device: Foley catheter Other: expectative Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy
Actual Study Start Date : March 31, 2017
Actual Primary Completion Date : October 23, 2019
Actual Study Completion Date : October 23, 2019

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Labour ward [ Time Frame: at term birth +5 days ]
  2. Total dose of prostaglandin used in case of cervical ripening. [ Time Frame: During labor ]
  3. Utilization rate of oxytocin [ Time Frame: During labor ]
  4. Total dose of Ocytocin used or not for induction labor [ Time Frame: During labor ]
  5. number of birth [ Time Frame: between the term consultation + 4 days (randomization) and delivery time ]
  6. delivery rate [ Time Frame: within 24 hours and 48 hours after randomization ]
  7. Caesarean rate [ Time Frame: before labor and during labor ]
  8. 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)

  9. Fetal complications [ Time Frame: through study completion, at 4 day ]
  10. Neonatal complications [ Time Frame: through study completion, at 4 day ]
  11. Duration of hospital stay [ Time Frame: through study completion, at 4 day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932319


Locations
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France
CHU de Caen
Caen, France
Hôpital Jeanne de Flandre - CHRU
Lille, France
CH Roubaix
Roubaix, France
CHU Rouen
Rouen, France
Ch Valenciennes
Valenciennes, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Charles Garabedian, MD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02932319    
Other Study ID Numbers: 2015_10
2015-A01298-41 ( Other Identifier: ID-RCB number, ANSM )
PHRCI_2014 ( Other Identifier: PHRC number, DGOS )
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
induction of labour
nulliparous
prolonged pregnancy
foley catheter
vaginal birth
Additional relevant MeSH terms:
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Pregnancy, Prolonged
Pregnancy Complications