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

NCT02593292 | Completed

• 1 other identifier: 69HCL14_0454
• Study Type: interventional
• Target: 1,532
• Locations: 1 country
• Sites: 2

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.

Conditions

Pregnancy

Keywords

Clinical pathway; Electronic Health Records; Maternal Health Services & administration; Patient Access to Records; Patient Satisfaction; Prenatal Care/methods

Outcome Measures

Primary Outcomes (1)

• 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.

  at the end of pregnancy

Secondary Outcomes (10)

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

  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

  From 22 completed weeks (154 days) of gestation to seven completed days after birth

• completeness of all hospital medical records

  the end of pregnancy (the date of delivery)

• health care costs

  one week from the date of delivery

• health care costs

  one week from the date of delivery

Study Arms (2)

PROSPERO group (intervention group)

ACTIVE COMPARATOR

Behavioral: PROSPERO

control group

PLACEBO COMPARATOR

Other: control

Interventions

PROSPERO 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.

PROSPERO group (intervention group)

control 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.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Hôpital Femme Mère Enfant

Bron, 69677, France

Location

Hospices Civils de Lyon

Lyon, 69002, France

Location

Related Publications (1)

• Gaucher L, Puill C, Baumann S, Hommey S, Touzet S, Rudigoz RC, Cortet M, Huissoud C, Gaucherand P, Dupont C, Mougeot F. The challenge of adopting a collaborative information system for independent healthcare workers in France: a comprehensive study. Sci Rep. 2024 May 19;14(1):11429. doi: 10.1038/s41598-024-62164-2.

  PMID: 38763960 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• René-Charles RUDIGOZ, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: November 2, 2015
• Study Start: December 5, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

FR (2)