Outpatient Induction of Labour Using a Double Balloon Transcervical Catheter in Low-risk Pregnant Women: a Two-centre Open Prospective Randomised Controlled Trial - OutCRIB
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Outpatient, Inpatient.
- Who it may be relevant to
- Registry conditions: Pregnant Women. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Outpatient
Women return at home - Other Inpatient
Women stay at hospital
Primary outcome measures
- compare the duration of induction and labor between outpatient and inpatient care. [Time frame: 72 hours]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 2 centers
- CHU de Nantes — Nantes
- CHD Vendée — La Roche-sur-Yon
Identifiers
NCT: NCT07265518 · RC24_0036 · 2024-A02122-45