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

Civil Hospices of Lyon

Status: Completed

Conditions: Pregnancy

Treatments: Behavioral: PROSPERO; Other: control

Study type: Interventional

Funder types: Other

Identifiers

NCT02593292

69HCL14_0454

Details and patient eligibility

About

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.

Enrollment: 1,532 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,532 participants in 2 patient groups, including a placebo group

PROSPERO group (intervention group)

Active Comparator group

Treatment:

Behavioral: PROSPERO

control group

Placebo Comparator group

Treatment:

Other: control