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

Pregnancy Clinical Trial

— PROSPERO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593292
• Other study ID #: 69HCL14_0454
• Status: Completed
• Phase: N/A
• Start date: December 5, 2016
• Est. completion date: July 2018

Study information

• Verified date: February 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1532
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

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.

Locations

Country	Name	City	State
France	Hôpital Femme Mère Enfant	Bron
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	health care costs	Number of medical visits and hospitalization	one week from the date of delivery
Secondary	health care costs	duration of medical visits and hospitalization	one week from the date of delivery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	types of delivery	rate of vaginal delivery, instrumental extraction delivery, Caesarean delivery	within one week from the date of delivery

External Links

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