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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02122-45 | Registry Identifier | RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient | Experimental | patients randomized to this arm will go home until labour or 24 hours after balloon insertion |
|
| Inpatient | Active Comparator | patients 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Outpatient | Other | Women return at home |
| |
| Inpatient |
| Measure | Description | Time Frame |
|---|---|---|
| compare the duration of induction and labor between outpatient and inpatient care. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Compare maternal satisfaction from induction to delivery between the two groups outpatient and inpatient via EXIT questionnaire | 48 hours | |
| Compare maternal morbidity and mortality between the two groups outpatient and inpatient | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Observational study: Determine patients' reasons for refusing to participate in the randomized study via an internal questionnaire | 72 hours | |
| 8. Observational study: Compare maternal satisfaction with induction between the "patients randomized to hospitalization" and "non-randomized patients (hospitalized)" groups via EXIT questionnaire |
Inclusion Criteria:
Exclusion Criteria:
female gender
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MARION GAUTIER | Contact | +33253526204 | marion.gautier@chu-nantes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Vincent DOCHEZ, Dr | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Recruiting | Nantes | Loire Atlantique | 44093 | France |
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| Other |
Women stay at hospital |
|
| Compare neonatal morbidity and mortality between the two groups outpatient and inpatient | 48 hours |
| Compare the number of hospital beds freed up and the number of concurrent induction in the department | 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 | 1 month |
| 72 hours |
| CHD Vendée | Recruiting | La Roche-sur-Yon | vendée | 85000 | France |
|
| ID | Term |
|---|---|
| D007291 | Inosine Monophosphate |
| ID | Term |
|---|---|
| D007292 | Inosine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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