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Completed

NCT Number: NCT02593292

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

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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Key information

Conditions

Pregnancy Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Femme Mère Enfant, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PROSPERO

Behavioral

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.

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.

Primary outcomes

  1. Rate of patients'pathway approved as compliant in the intervention group compared to the control group.

    Time frame: at the end of pregnancy

    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.

Secondary outcomes

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

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

  2. rate of perinatal morbidity-mortality as defined by the Organization, Practices Evaluation in perinatal Network

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

  3. completeness of all hospital medical records

    Time frame: the end of pregnancy (the date of delivery)

    completeness of hospital medical records compared to electronic patient-reported outcome (ePRO).

  4. health care costs

    Time frame: one week from the date of delivery

    Number of medical visits and hospitalization

  5. health care costs

    Time frame: one week from the date of delivery

    duration of medical visits and hospitalization

  6. patients' satisfaction : Qualitative evaluation by interview

    Time frame: at the end of pregnancy

    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

  7. patients' satisfaction : Quantitative evaluation by the hospital anxiety and depression scale

    Time frame: at the end of pregnancy

    Quantitative evaluation of patients' satisfaction and anxiety by the hospital anxiety and depression scale

  8. patients' satisfaction : Qualitative evaluation by interview

    Time frame: within one week from the date of delivery

    Qualitative evaluation of patients' satisfaction and adherence by interview and/or focus groups.

  9. patients' satisfaction : Quantitative evaluation by the hospital anxiety and depression scale

    Time frame: within one week from the date of delivery

    Quantitative evaluation of patients' satisfaction and anxiety by the hospital anxiety and depression scale and other validated's patient satisfaction forms

  10. types of delivery

    Time frame: within one week from the date of delivery

    rate of vaginal delivery, instrumental extraction delivery, Caesarean delivery

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: PROSPERO

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 2, 2015
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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