PregnancyPROSPERONCT02593292
Program of Research for the Optimization of a Supervised Patient Pathway for Expectant According to Risk in Obstetrics
A study testing PROSPERO in people with Pregnancy, run by Hospices Civils de Lyon at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- PROSPERO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,532 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Dec 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Femme Mère Enfant
Bron, 69677
Hospices Civils de Lyon
Lyon, 69002
About this study
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
- Being tested
- PROSPERO, control
- Keywords
- Clinical pathway, Electronic Health Records, Maternal Health Services & administration, Patient Access to Records, Patient Satisfaction, Prenatal Care/methods
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROSPEROBehavioural
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.
controlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PROSPERO group (intervention group) | Active comparator | Not described Receives: Behavioral: PROSPERO |
| control group | Placebo comparator | Not described Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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).
Measured: the end of pregnancy (the date of delivery)
health care costs
Number of medical visits and hospitalization
Measured: one week from the date of delivery
health care costs
duration of medical visits and hospitalization
Measured: 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
Measured: 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
Measured: at the end of pregnancy
patients' satisfaction : Qualitative evaluation by interview
Qualitative evaluation of patients' satisfaction and adherence by interview and/or focus groups.
Measured: 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
Measured: within one week from the date of delivery
types of delivery
rate of vaginal delivery, instrumental extraction delivery, Caesarean delivery
Measured: within one week from the date of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study start5 Dec 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- René-Charles RUDIGOZ, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593292
- Sponsor's protocol ID
- 69HCL14_0454
- Acronym
- PROSPERO
- Status last verified
- Aug 2025
- First submitted
- 28 Oct 2015
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38763960
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program of Research for the Optimization of a Supervised Patient Pathway for Expectant According to Risk in Obstetrics
- ClinicalTrials.gov ID
- NCT02593292
- Acronym / sponsor ID
- PROSPERO / 69HCL14_0454
- Conditions
- Pregnancy
- Keywords
- Clinical pathway, Electronic Health Records, Maternal Health Services & administration, Patient Access to Records, Patient Satisfaction, Prenatal Care/methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,532 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 2 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROSPERO group (intervention group) | Active comparator | Behavioral: PROSPERO |
| control group | Placebo comparator | Other: control |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- illiterate patients,
- non-French speakers,
- under the age of majority,
- refusing to participate,
- without internet access,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROSPEROThe 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. | Behavioural | PROSPERO group (intervention group) |
| controlAt 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. | Other | control group |
Primary outcome
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.
10 secondary outcomes
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
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
completeness of all hospital medical records
Time frame: the end of pregnancy (the date of delivery)
health care costs
Time frame: one week from the date of delivery
health care costs
Time frame: one week from the date of delivery
patients' satisfaction : Qualitative evaluation by interview
Time frame: at the end of pregnancy
patients' satisfaction : Quantitative evaluation by the hospital anxiety and depression scale
Time frame: at the end of pregnancy
patients' satisfaction : Qualitative evaluation by interview
Time frame: within one week from the date of delivery
patients' satisfaction : Quantitative evaluation by the hospital anxiety and depression scale
Time frame: within one week from the date of delivery
types of delivery
Time frame: within one week from the date of delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 38763960Gaucher 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René-Charles RUDIGOZ, Pr principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROSPERO in people with Pregnancy, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients'pathway approved as compliant in the intervention group compared to the control group. (time frame: at the end of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02593292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.