Outpatient Induction of Labour Using a Double Balloon Transcervical Catheter in Low-risk Pregnant Women: a Two-centre Open Prospective Randomised Controlled Trial - OutCRIB

Nantes University Hospital (NUH)

Status: Not yet enrolling

Conditions: Pregnant Women

Treatments: Other: Inpatient; Other: Outpatient

Study type: Interventional

Funder types: Other

Identifiers

NCT07265518

RC24_0036

2024-A02122-45 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 258 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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258 participants in 3 patient groups

Outpatient

Experimental group

Description:

patients randomized to this arm will go home until labour or 24 hours after balloon insertion

Treatment:

Other: Outpatient

Inpatient

Active Comparator group

Description:

patients randomized to this arm will stay at hospital

Treatment:

Other: Inpatient

observationnal study

No Intervention group

Description:

patients refusing to be randomized will be able to enter this cohort without their care affecting the site's usual clinical practice