Induction of LabourFOLOUTNCT02932319
Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy
A study testing Foley catheter and expectative in people with Induction of Labour and Prolonged Pregnancy, run by University Hospital, Lille at 5 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labour, Prolonged Pregnancy
- What is being tested?
- Foley catheter and expectative
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 5 sitesFrance
- Study dates
- 31 Mar 2017to 23 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- prolonged pregnancy (D+4) nulliparous no complication during pregnancy location near th hospital (20 mn by car) Bishop < 6
Who cannot join
- medical history small for gestationnal age PROM Live alone
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Caen
Caen
Hôpital Jeanne de Flandre - CHRU
Lille
CH Roubaix
Roubaix
CHU Rouen
Rouen
Ch Valenciennes
Valenciennes
About this study
15 to 20 % of nulliparous needs an induction at term. None study has evaluated Foley catheter induction at home versus expectative in this population
- Conditions
- Induction of Labour, Prolonged Pregnancy
- Being tested
- Foley catheter, expectative
- Keywords
- induction of labour, nulliparous, prolonged pregnancy, foley catheter, vaginal birth
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley catheterDevice
The Foley cathter will be inserted at term + 4 days for 24 hours.
expectativeOther
expectative until the next day befor starting the induction
| Study group | Role | What they receive |
|---|---|---|
| Foley catheter | Active comparator | The patient will have an induction at home after 60 mn of fetal heart rate monitoring. Receives: Device: Foley catheter |
| Expectative | Sham comparator | The patient in this arm will have the actual care (expectative until the next day befor starting the induction) Receives: Other: expectative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bishop score
Measure the evolution of Bishop score,change between the randomization and the return of the patient
Measured: at term birth +5 days
Secondary outcomes (11)
Labour ward
Measured: at term birth +5 days
Total dose of prostaglandin used in case of cervical ripening.
Measured: During labor
Utilization rate of oxytocin
Measured: During labor
Total dose of Ocytocin used or not for induction labor
Measured: During labor
number of birth
Measured: between the term consultation + 4 days (randomization) and delivery time
delivery rate
Measured: within 24 hours and 48 hours after randomization
Caesarean rate
Measured: before labor and during labor
Maternal complications
It's the time between the term consultation + 4 days (randomization) and delivery time (day 4)
Measured: through study completion, at 4 day
Fetal complications
Measured: through study completion, at 4 day
Neonatal complications
Measured: through study completion, at 4 day
Duration of hospital stay
Measured: through study completion, at 4 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start31 Mar 2017
- Primary completion23 Oct 2019
- Study completion23 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Induction of LabourStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Garabedian, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932319
- Sponsor's protocol ID
- 2015_10
- Other IDs
- 2015-A01298-41, PHRCI_2014
- Acronym
- FOLOUT
- Status last verified
- Apr 2026
- First submitted
- 4 Oct 2016
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38997091
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy
- ClinicalTrials.gov ID
- NCT02932319
- Acronym / sponsor ID
- FOLOUT / 2015_10
- Conditions
- Induction of Labour, Prolonged Pregnancy
- Keywords
- induction of labour, nulliparous, prolonged pregnancy, foley catheter, vaginal birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 23 Oct 2019 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foley catheter | Active comparator | Device: Foley catheterThe patient will have an induction at home after 60 mn of fetal heart rate monitoring. |
| Expectative | Sham comparator | Other: expectativeThe patient in this arm will have the actual care (expectative until the next day befor starting the induction) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- prolonged pregnancy (D+4) nulliparous no complication during pregnancy location near th hospital (20 mn by car) Bishop < 6
Key exclusion criteria (1 listed)
- medical history small for gestationnal age PROM Live alone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foley catheterThe Foley cathter will be inserted at term + 4 days for 24 hours. | Device | Foley catheter |
| expectativeexpectative until the next day befor starting the induction | Other | Expectative |
Primary outcome
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
11 secondary outcomes
Labour ward
Time frame: at term birth +5 days
Total dose of prostaglandin used in case of cervical ripening.
Time frame: During labor
Utilization rate of oxytocin
Time frame: During labor
Total dose of Ocytocin used or not for induction labor
Time frame: During labor
number of birth
Time frame: between the term consultation + 4 days (randomization) and delivery time
delivery rate
Time frame: within 24 hours and 48 hours after randomization
Caesarean rate
Time frame: before labor and during labor
Maternal complications
Time frame: through study completion, at 4 day
Fetal complications
Time frame: through study completion, at 4 day
Neonatal complications
Time frame: through study completion, at 4 day
Duration of hospital stay
Time frame: through study completion, at 4 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Results publication: PubMed 38997091Garabedian 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.
- Individual participant dataSharing planned: No
Related trials for Induction of Labour
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Recruiting
The Ophthalmic Artery Doppler Evaluation Prior to Labor Induction and Adverse Intrapartum Fetal Outcomes
Ophthalmic Artery, Labor and Delivery
Active, not recruiting
Calcium Carbonate on Labor Induction
Pregnancy, Uterine Contraction
Not yet recruiting
The WAIT Trial: Waiting Versus Active Induction at Term in Women With A1 Gestational Diabetes Mellitus
Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Garabedian, MD principal investigator
University Hospital, Lille
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foley catheter and expectative in people with Induction of Labour and Prolonged Pregnancy, run by University Hospital, Lille at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bishop score (time frame: at term birth +5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02932319, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.