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

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 Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Behavioral: PROSPERO; Other: control

• Study Type: Interventional
• Enrollment (Actual): 1532
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Hôpital Femme Mère Enfant
  • Lyon, France, 69002
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group	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.
Active Comparator: PROSPERO group (intervention group)	Behavioral: PROSPERO; The intervention is carried out in 3 steps: 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.; 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; The entrance in the delivery room: patients are classified as low or high risk for greater vigilance from midwives.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	completeness of hospital medical records compared to electronic patient-reported outcome (ePRO).	the end of pregnancy (the date of delivery)
health care costs	Number of medical visits and hospitalization	one week from the date of delivery
health care costs	duration of medical visits and hospitalization	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	at the end of pregnancy
patients' satisfaction : Quantitative evaluation by the hospital anxiety and depression scale	Quantitative evaluation of patients' satisfaction and anxiety by the hospital anxiety and depression scale	at the end of pregnancy
patients' satisfaction : Qualitative evaluation by interview	Qualitative evaluation of patients' satisfaction and adherence by interview and/or focus groups.	within one week from the date of delivery
patients' satisfaction : Quantitative evaluation by the hospital anxiety and depression scale	Quantitative evaluation of patients' satisfaction and anxiety by the hospital anxiety and depression scale and other validated's patient satisfaction forms	within one week from the date of delivery
types of delivery	rate of vaginal delivery, instrumental extraction delivery, Caesarean delivery	within one week from the date of delivery

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: René-Charles RUDIGOZ, Pr, Hospices Civils de Lyon

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: October 28, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): November 1, 2015

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Patient Satisfaction; Electronic Health Records; Clinical pathway; Maternal Health Services & administration; Patient Access to Records; Prenatal Care/methods
• Other Study ID Numbers: 69HCL14_0454