Psychiatric DisorderNCT04574986
Description of the Psychiatric Care Pathway of Pregnant Women After the Early Prenatal Interview
An observational study of Psychiatric Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Pregnancy and postpartum are recognized as periods of psychic fragility. However, the psychiatric disorders of women that can emerge during these periods are underdiagnosed and have consequences in particular on the development of the child, his relationship with his parents. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Psychiatric Disorder
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 30 Mar 2020
- Phase
- Observational
- 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
Study population: Pregnant women who had an EPP at Montpellier's hospital between March 2019 and March 2020.
Who may be able to join
- No opposition from women to participate in the study
- Women over 18
- Women who had an EPP at Montpellier University Hospital between March 2019 and March 2020
Who cannot join
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Prenatal Interview : Throwback to the Hospital of Montpellier's Experience and Description of the Psychiatric Care Pathway of Pregnant Women.
Pregnancy and postpartum are recognized as periods of psychic fragility. However, the psychiatric disorders of women that can emerge during these periods are underdiagnosed and have consequences in particular on the development of the child, his relationship with his parents.
The need for an early diagnosis to allow appropriate treatment seems to be essential.
Read more
The pregnancy monitoring is centered on the somatic and little on psychological evaluation of the mother and the father.
In this context, the Early Prenatal Interview (EPP) was created through the perinatal plan of 2005-2007 in order to allow a more precise research of the factors of vulnerabilities likely to be predictive of a somatic, psychological or social disorder.
However, until now, only few pregnant women benefited of this interview. In May 2020, EPP became mandatory for all pregnant women. It now seems important to clearly identify the place, function, organization and usefulness of this interview in order to maximize its benefit in the monitoring of pregnancy
Read the detailed description
First, the investigators will describe the care pathway for pregnant women who have benefited of an early prenatal interview (EPP) between March 2019 and March 2020, namely continued classic follow-up or referral to a child psychiatrist / psychiatrist.
Then, the investigators will define two subgroups within the women oriented towards psychiatric follow-up: those who had this follow-up and those who did not.
Then, the investigators will identify the factors of failure of this referral to psychiatric follow-up and describe the eventual difficulties encountered by the lack of this follow-up.
Finally, the investigators will try to study these observations made with the perspective of maximizing the benefit of the Early Prenatal Interview in the monitoring of pregnancy.
- Conditions
- Psychiatric Disorder
- Keywords
- Orientation to a psychiatric follow-up after EPP, Early Prenatal Interview, Psychiatric disorder during pregnancy
- Medical subject headings
- Mental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of pregnant women who have been oriented to a psychiatric follow-up after EPP.
Percentage of pregnant women who have been oriented to a psychiatric follow-up after EPP.
Measured: 1 day
Secondary outcomes (3)
Description of the psychiatric care path after Early Prenatal Interview
Description of the psychiatric care path after Early Prenatal Interview so :
- percentage of pregnant women who were referred to a midwife
- percentage of pregnant women who were referred to a child psychiatrist
- percentage of pregnant women who were referred to an adult psychiatrist
- percentage of pregnant women who were referred to an other follow-up
Measured: 1 day
Identification of potential factors of failure.
Identification of potential factors of failure : In the number of women who were referral to a child psychiatrist / psychiatrist, search the number of women who didn't see the child or adult psychiatrist and try to identify why for each of these women
Measured: 1 day
Number of Participants with difficulties caused by the lack of follow-up
Number of Participants with difficulties caused by the lack of follow-up as :
Search for each women who were referral to a child or adult psychiatrist ;
- mode of delivery and term
- complications of delivery for the baby or mother
- hospitalization in psychiatry
- prolongation of stay in the maternity Then compare for these criterias in women who see the child or adult psychiatrist or women who didn't see him and see if the difficulties are more present in women who didn't have the follow-up
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Mar 2019
- Primary completion1 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline AVIT, resident, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574986
- Sponsor's protocol ID
- RECHMPL20_0452
- Status last verified
- Sep 2020
- First submitted
- 11 Sep 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prenatal Interview : Throwback to the Hospital of Montpellier's Experience and Description of the Psychiatric Care Pathway of Pregnant Women.
- ClinicalTrials.gov ID
- NCT04574986
- Acronym / sponsor ID
- RECHMPL20_0452
- Conditions
- Psychiatric Disorder
- Keywords
- Orientation to a psychiatric follow-up after EPP, Early Prenatal Interview, Psychiatric disorder during pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 5 Oct 2020 (actual)
- 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.
Pregnancy and postpartum are recognized as periods of psychic fragility. However, the psychiatric disorders of women that can emerge during these periods are underdiagnosed and have consequences in particular on the development of the child, his relationship with his parents.
The need for an early diagnosis to allow appropriate treatment seems to be essential.
The pregnancy monitoring is centered on the somatic and little on psychological evaluation of the mother and the father.
In this context, the Early Prenatal Interview (EPP) was created through the perinatal plan of 2005-2007 in order to allow a more precise research of the factors of vulnerabilities likely to be predictive of a somatic, psychological or social disorder.
However, until now, only few pregnant women benefited of this interview. In May 2020, EPP became mandatory for all pregnant women. It now seems important to clearly identify the place, function, organization and usefulness of this interview in order to maximize its benefit in the monitoring of pregnancy
Detailed description
First, the investigators will describe the care pathway for pregnant women who have benefited of an early prenatal interview (EPP) between March 2019 and March 2020, namely continued classic follow-up or referral to a child psychiatrist / psychiatrist.
Then, the investigators will define two subgroups within the women oriented towards psychiatric follow-up: those who had this follow-up and those who did not.
Then, the investigators will identify the factors of failure of this referral to psychiatric follow-up and describe the eventual difficulties encountered by the lack of this follow-up.
Finally, the investigators will try to study these observations made with the perspective of maximizing the benefit of the Early Prenatal Interview in the monitoring of pregnancy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women who had an EPP at Montpellier's hospital between March 2019 and March 2020.
Key inclusion criteria (3 listed)
- No opposition from women to participate in the study
- Women over 18
- Women who had an EPP at Montpellier University Hospital between March 2019 and March 2020
Key exclusion criteria (1 listed)
- age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of pregnant women who have been oriented to a psychiatric follow-up after EPP.
Time frame: 1 day
Percentage of pregnant women who have been oriented to a psychiatric follow-up after EPP.
3 secondary outcomes
Description of the psychiatric care path after Early Prenatal Interview
Time frame: 1 day
Identification of potential factors of failure.
Time frame: 1 day
Number of Participants with difficulties caused by the lack of follow-up
Time frame: 1 day
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 6 Oct 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Pauline AVIT, resident principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorder, run by University Hospital, Montpellier at 1 site 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 3 inclusion and 1 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 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Percentage of pregnant women who have been oriented to a psychiatric follow-up after EPP. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2020.