Clinical trial NCT02593292: Program of Research for the Optimization of a Supervised Patient Pathway for Expectant According to Risk in Obstetrics
Official title: Program of Research for the Optimization of a Supervised Patient Pathway for Expectant According to Risk in Obstetrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Clinical pathway
Electronic Health Records
Maternal Health Services & administration
Patient Access to Records
Patient Satisfaction
Prenatal Care/methods
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 1532
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Rate of patients'pathway approved as compliant in the intervention group compared to the control group.
timeFrame: at the end of pregnancy
Secondary outcomes:
measure: rate of severe maternal morbidity and mortality as defined by the EPIdémiologie de la MOrbidité Maternelle Sévère (EPINOMS) project
timeFrame: From 22 completed weeks (154 days) of gestation to seven completed days after birth
measure: rate of perinatal morbidity-mortality as defined by the Organization, Practices Evaluation in perinatal Network
timeFrame: From 22 completed weeks (154 days) of gestation to seven completed days after birth
measure: completeness of all hospital medical records
timeFrame: the end of pregnancy (the date of delivery)
measure: health care costs
timeFrame: one week from the date of delivery
measure: health care costs
timeFrame: one week from the date of delivery
measure: patients' satisfaction : Qualitative evaluation by interview
timeFrame: at the end of pregnancy
measure: patients' satisfaction : Quantitative evaluation by the hospital anxiety and depression scale
timeFrame: at the end of pregnancy
measure: patients' satisfaction : Qualitative evaluation by interview
timeFrame: within one week from the date of delivery
measure: patients' satisfaction : Quantitative evaluation by the hospital anxiety and depression scale
timeFrame: within one week from the date of delivery
measure: types of delivery
timeFrame: within one week from the date of delivery
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: René-Charles RUDIGOZ, Pr
role: PRINCIPAL_INVESTIGATOR
References: