Pregnant WomenOutCRIBNCT07265518
Outpatient Induction of Labour Using a Double Balloon Transcervical Catheter in Low-risk Pregnant Women: a Two-centre Open Prospective Randomised Controlled Trial - OutCRIB
A study testing Outpatient and Inpatient in people with Pregnant Women, run by Nantes University Hospital at 2 sites in France.
Trial summary
The aim goal of this study is to compare the duration of induction and labor between outpatient and inpatient care in low-risk pregnant women. The secondary objectives are to compare between the two groups the maternal satisfaction from induction to delivery, the maternal and neonatal morbidity and mortality, impact… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Outpatient and Inpatient
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Apr 2026to 15 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant woman with singleton pregnancy in cephalic presentation
- Term ≥ 37SA+0d
- Age ≥ 18 years
- Affiliated or beneficiary of a social security scheme
- No severe maternal/neonatal pathology (severe pre-eclampsia, intra-uterine growth retardation, etc.)
- Indication for balloon induction
Show all 9Show fewer
- Bishop score <6
- Home-hospital distance ≤ 30 minutes' drive
- Presence of a family member at the woman's side to help her return home
Who cannot join
- Scarred uterus
- Fetal heart rhythm abnormalities
- Rupture of membranes
- Death in utero
- Placenta previa or adherent placenta (accreta or percreta)
- Maternal respiratory, cardiac, hepatic, renal, digestive or decompensated psychiatric pathology
- Anamnios
- Patient under guardianship, curatorship and/or safeguard of justice
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHD Vendée
La Roche-sur-Yon, vendée, 85000
Emelyne Dr LEFIZELIER, 0251446161, Emelyne.lefizelier@ght85.fr
- Recruiting
CHU de Nantes
Nantes, Loire Atlantique, 44093
Vincent DOCHEZ, Dr, 0240083177, vincent.dochez@chu-nantes.fr
About this study
The aim goal of this study is to compare the duration of induction and labor between outpatient and inpatient care in low-risk pregnant women.
The secondary objectives are to compare between the two groups the maternal satisfaction from induction to delivery, the maternal and neonatal morbidity and mortality, impact on service organization and a medico-economic evaluation (cost-consequence analysis) from a collective perspective and with a time horizon of one month For women who do not agree to take part in the randomized study, an observational study will be proposed to them in order to collect the reason for their refusal and their maternal satisfaction.
Read more
Researchers will compare the return home with conventional hospitalization
Patients presenting with a singleton pregnancy and with an indication for induction of labor will be proposed to participate in the study.
If the pregnant woman refuses to participate in the randomized study, she will be invited to take part in the observational study.
For women who accept, a fetal heart rate recording (FHRR) is made prior to balloon insertion. If there is no fetal heart rhythm abnormality (FHR), the double balloon catheter is inserted by a midwife. A further ERCF is performed to ensure that the procedure is well tolerated.
In the absence of metrorrhagia, fetal heart rate abnormalities, rupture of the water sac or uterine hypertonia/hyperkinesia, the patient will then be randomized to either the in-patient or out-patient arm. The patient will either be placed in a room or go home.
In both cases, the balloon will be removed after 24 hours in hospital in the absence of spontaneous labor, and the patient will be referred to the delivery room for water breakage and/or oxytocin infusion for induction.
- Conditions
- Pregnant Women
- Being tested
- Outpatient, Inpatient
- Keywords
- outpatient labor induction, low-risk pregnant women, transcervical catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OutpatientOther
Women return at home
InpatientOther
Women stay at hospital
| Study group | Role | What they receive |
|---|---|---|
| Outpatient | Experimental | patients randomized to this arm will go home until labour or 24 hours after balloon insertion Receives: Other: Outpatient |
| Inpatient | Active comparator | patients randomized to this arm will stay at hospital Receives: Other: Inpatient |
| observationnal study | No intervention | patients refusing to be randomized will be able to enter this cohort without their care affecting the site's usual clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the duration of induction and labor between outpatient and inpatient care.
Measured: 72 hours
Secondary outcomes (5)
Compare maternal satisfaction from induction to delivery between the two groups outpatient and inpatient via EXIT questionnaire
Measured: 48 hours
Compare maternal morbidity and mortality between the two groups outpatient and inpatient
Measured: 48 hours
Compare neonatal morbidity and mortality between the two groups outpatient and inpatient
Measured: 48 hours
Compare the number of hospital beds freed up and the number of concurrent induction in the department
Measured: 24 hours
Compare medico-economic evaluation (cost-consequence analysis) from a collective perspective and with a time horizon of one month between the two groups outpatient and inpatient
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start30 Apr 2026
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent DOCHEZ, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265518
- Sponsor's protocol ID
- RC24_0036
- Other IDs
- 2024-A02122-45
- Acronym
- OutCRIB
- Status last verified
- May 2026
- First submitted
- 1 Oct 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Induction of Labour Using a Double Balloon Transcervical Catheter in Low-risk Pregnant Women: a Two-centre Open Prospective Randomised Controlled Trial - OutCRIB
- ClinicalTrials.gov ID
- NCT07265518
- Acronym / sponsor ID
- OutCRIB / RC24_0036
- Conditions
- Pregnant Women
- Keywords
- outpatient labor induction, low-risk pregnant women, transcervical catheter
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 4 Dec 2025 (actual)
- 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.
The aim goal of this study is to compare the duration of induction and labor between outpatient and inpatient care in low-risk pregnant women.
The secondary objectives are to compare between the two groups the maternal satisfaction from induction to delivery, the maternal and neonatal morbidity and mortality, impact on service organization and a medico-economic evaluation (cost-consequence analysis) from a collective perspective and with a time horizon of one month For women who do not agree to take part in the randomized study, an observational study will be proposed to them in order to collect the reason for their refusal and their maternal satisfaction.
Researchers will compare the return home with conventional hospitalization
Patients presenting with a singleton pregnancy and with an indication for induction of labor will be proposed to participate in the study.
If the pregnant woman refuses to participate in the randomized study, she will be invited to take part in the observational study.
For women who accept, a fetal heart rate recording (FHRR) is made prior to balloon insertion. If there is no fetal heart rhythm abnormality (FHR), the double balloon catheter is inserted by a midwife. A further ERCF is performed to ensure that the procedure is well tolerated.
In the absence of metrorrhagia, fetal heart rate abnormalities, rupture of the water sac or uterine hypertonia/hyperkinesia, the patient will then be randomized to either the in-patient or out-patient arm. The patient will either be placed in a room or go home.
In both cases, the balloon will be removed after 24 hours in hospital in the absence of spontaneous labor, and the patient will be referred to the delivery room for water breakage and/or oxytocin infusion for induction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Outpatient | Experimental | Other: Outpatientpatients randomized to this arm will go home until labour or 24 hours after balloon insertion |
| Inpatient | Active comparator | Other: Inpatientpatients randomized to this arm will stay at hospital |
| observationnal study | No intervention | –patients refusing to be randomized will be able to enter this cohort without their care affecting the site's usual clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pregnant woman with singleton pregnancy in cephalic presentation
- Term ≥ 37SA+0d
- Age ≥ 18 years
- Affiliated or beneficiary of a social security scheme
- No severe maternal/neonatal pathology (severe pre-eclampsia, intra-uterine growth retardation, etc.)
Key exclusion criteria (8 listed)
- Scarred uterus
- Fetal heart rhythm abnormalities
- Rupture of membranes
- Death in utero
- Placenta previa or adherent placenta (accreta or percreta)
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 |
|---|---|---|
| OutpatientWomen return at home | Other | Outpatient |
| InpatientWomen stay at hospital | Other | Inpatient |
Primary outcome
compare the duration of induction and labor between outpatient and inpatient care.
Time frame: 72 hours
5 secondary outcomes
Compare maternal satisfaction from induction to delivery between the two groups outpatient and inpatient via EXIT questionnaire
Time frame: 48 hours
Compare maternal morbidity and mortality between the two groups outpatient and inpatient
Time frame: 48 hours
Compare neonatal morbidity and mortality between the two groups outpatient and inpatient
Time frame: 48 hours
Compare the number of hospital beds freed up and the number of concurrent induction in the department
Time frame: 24 hours
Compare medico-economic evaluation (cost-consequence analysis) from a collective perspective and with a time horizon of one month between the two groups outpatient and inpatient
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Vincent DOCHEZ, Dr principal investigator
Nantes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient and Inpatient in people with Pregnant Women, run by Nantes University Hospital at 2 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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MARION GAUTIER (+33253526204, marion.gautier@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the duration of induction and labor between outpatient and inpatient care. (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026.