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New treatment option for Pregnant Women
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
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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.)
You likely can't join if
- 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
See the full eligibility criteria
- 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
- Bishop score \<6
- Home-hospital distance ≤ 30 minutes' drive
- Presence of a family member at the woman's side to help her return home
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nantes, Loire Atlantique, France
- La Roche-sur-Yon, vendée, France
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantes, Loire Atlantique, France; La Roche-sur-Yon, vendée, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.