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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1532 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-05

Study Completion Date

2018-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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PROSPERO group (intervention group)

Group Type ACTIVE_COMPARATOR

PROSPERO

Intervention Type BEHAVIORAL

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.

control group

Group Type PLACEBO_COMPARATOR

control

Intervention Type 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.

Interventions

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PROSPERO

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.

Intervention Type BEHAVIORAL

control

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.

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No