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This French multicentre open-label randomized trial will test the hypothesis that a coordinated health circuit based on obstetric risks, backed up by an electronic patient care reporting information system will optimize the continuum of pregnancy care monitoring. The electronic patient care reporting information system will be shared between patients, private practice physicians/midwifes, hospital physicians/midwifes and supervised by a coordinating midwife.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROSPERO group (intervention group) | Active Comparator |
| |
| control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROSPERO | Behavioral | The intervention is carried out in 3 steps:
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients'pathway approved as compliant in the intervention group compared to the control group. | Compliant patient pathways are those for which all actions (medical visits, examinations, …) recommended during pregnancy, according to the specific risk factors of each patient, will have been made. | at the end of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| rate of severe maternal morbidity and mortality as defined by the EPIdémiologie de la MOrbidité Maternelle Sévère (EPINOMS) project | From 22 completed weeks (154 days) of gestation to seven completed days after birth | |
| rate of perinatal morbidity-mortality as defined by the Organization, Practices Evaluation in perinatal Network |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| René-Charles RUDIGOZ, Pr | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Femme Mère Enfant | Bron | 69677 | France | |||
| Hospices Civils de Lyon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38763960 | Background | Gaucher L, Puill C, Baumann S, Hommey S, Touzet S, Rudigoz RC, Cortet M, Huissoud C, Gaucherand P, Dupont C, Mougeot F. The challenge of adopting a collaborative information system for independent healthcare workers in France: a comprehensive study. Sci Rep. 2024 May 19;14(1):11429. doi: 10.1038/s41598-024-62164-2. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| control | Other | At the start of the pregnancy, medical, obstetric and social risk factors are checked in the same way than the PROSPERO group. An adapted patient pathway was defined by a Clinical Research Assistant but unreachable from patients, midwifes and physicians. The electronic patient care reporting information system will be disabled and midwifes cannot create the classification checklist for low or high risk delivery. |
|
| From 22 completed weeks (154 days) of gestation to seven completed days after birth |
| completeness of all hospital medical records | completeness of hospital medical records compared to electronic patient-reported outcome (ePRO). | the end of pregnancy (the date of delivery) |
| health care costs | Number of medical visits and hospitalization | one week from the date of delivery |
| health care costs | duration of medical visits and hospitalization | one week from the date of delivery |
| patients' satisfaction : Qualitative evaluation by interview | Qualitative evaluation of patients' satisfaction and adherence by interview and/or focus groups. Quantitative evaluation of patients' satisfaction and anxiety by the hospital anxiety and depression scale and other validated's patient satisfaction forms | at the end of pregnancy |
| patients' satisfaction : Quantitative evaluation by the hospital anxiety and depression scale | Quantitative evaluation of patients' satisfaction and anxiety by the hospital anxiety and depression scale | at the end of pregnancy |
| patients' satisfaction : Qualitative evaluation by interview | Qualitative evaluation of patients' satisfaction and adherence by interview and/or focus groups. | within one week from the date of delivery |
| patients' satisfaction : Quantitative evaluation by the hospital anxiety and depression scale | Quantitative evaluation of patients' satisfaction and anxiety by the hospital anxiety and depression scale and other validated's patient satisfaction forms | within one week from the date of delivery |
| types of delivery | rate of vaginal delivery, instrumental extraction delivery, Caesarean delivery | within one week from the date of delivery |
| Lyon |
| 69002 |
| France |