Pregnancy
Conditions
Keywords
Clinical pathway, Electronic Health Records, Maternal Health Services & administration, Patient Access to Records, Patient Satisfaction, Prenatal Care/methods
Brief summary
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.
Interventions
BEHAVIORALPROSPERO
The intervention is carried out in 3 steps: 1. At the start of the pregnancy: a number of process steps are defined for a patient's pathway adapted to medical, obstetric and social risk factors. 2. During pregnancy: city based doctors and midwives work together with their hospital peers enabling patients to participate through the reporting via a medical information system 3. The entrance in the delivery room: patients are classified as low or high risk for greater vigilance from midwives.
OTHERcontrol
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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients over the age of majority, * enrolled in one of the two maternity hospitals in the study before 12 weeks of amenorrhea (SA) and 6 days (j) of age, * affiliated to the National Health Insurance Fund of the country within the regional level health insurance * have an internet access
Exclusion criteria
* illiterate patients, * non-French speakers, * under the age of majority, * refusing to participate, * without internet access, * followed by one of these maternity wards but delivering else where, * whose pregnancy ended in a miscarriage early or late (before 21 weeks of amenorrhea (SA) and 6 days (J) over).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients'pathway approved as compliant in the intervention group compared to the control group. | at the end of pregnancy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of perinatal morbidity-mortality as defined by the Organization, Practices Evaluation in perinatal Network | From 22 completed weeks (154 days) of gestation to seven completed days after birth | — |
| completeness of all hospital medical records | the end of pregnancy (the date of delivery) | completeness of hospital medical records compared to electronic patient-reported outcome (ePRO). |
| health care costs | one week from the date of delivery | Number of medical visits and hospitalization |
| 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 | — |
| patients' satisfaction : Quantitative evaluation by the hospital anxiety and depression scale | at the end of pregnancy | Quantitative evaluation of patients' satisfaction and anxiety by the hospital anxiety and depression scale |
| types of delivery | within one week from the date of delivery | rate of vaginal delivery, instrumental extraction delivery, Caesarean delivery |
| patients' satisfaction : Qualitative evaluation by interview | at the end of pregnancy | 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 |
Countries
France
Outcome results
None listed