Program of Research for the Optimization of a Supervised Patient Pathway for Expectant According to Risk in Obstetrics

Hospices Civils de Lyon1,532 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

1,532

Conditions

Pregnancy

Interventions

PROSPEROBEHAVIORAL

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.

controlOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (2)

Hôpital Femme Mère Enfant

Bron, France

Hospices Civils de Lyon

Lyon, France

Outcomes

Primary Outcomes

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.

Time frame: at the end of pregnancy

Secondary Outcomes

rate of severe maternal morbidity and mortality as defined by the EPIdémiologie de la MOrbidité Maternelle Sévère (EPINOMS) project

Time frame: 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

Time frame: 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).

Time frame: the end of pregnancy (the date of delivery)

health care costs

Number of medical visits and hospitalization

Time frame: one week from the date of delivery

health care costs

duration of medical visits and hospitalization

Time frame: 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

Data from ClinicalTrials.gov

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