Skip to main content
OpenTrials
Completed

NCT Number: NCT02932319

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Induction of Labour Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Pregnancy, Prolonged Prolonged Pregnancy Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Caen, Caen, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

foley catheter

Device

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

expectative

Other

expectative until the next day befor starting the induction

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: FOLOUT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 13, 2016
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.