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

NCT02593292 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1532

Last updated 2025-09-03

No results posted yet for this study

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.

Conditions

  • Pregnancy

Interventions

BEHAVIORAL

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.

OTHER

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.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • René-Charles RUDIGOZ, Pr · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-05
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02593292 on ClinicalTrials.gov