Post Partum DepressionNCT04506489
Access to Maternity and Risk Factors in a Non-consultant Population (PROXIMA)
An observational study of Post Partum Depression, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Characterize the psychic and medical disorders related to pregnancy and motherhood in a group of primiparous and primigratic women. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Post Partum Depression
- What is being tested?
- Psychological investigation
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 1 Jan 2021
- 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Primiparous women without mental and obstetric disorders monitoring in the Besançon University Hospital, during their pregnancy and after their birth.
Who may be able to join
- primiparous and primigest women,
- Singleton pregnancy
- Consultant at the University Hospital of Besançon in gynecology / obstetrics department - initial consultation
- 25 to 45 years old,
- European culture and speaking French,
- Living in a relationship with the spouse
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- Spontaneous pregnancy, without medical help
- Having agreed to the use of this medical data as part of this research and the completion of the self-questionnaires.
- Patients who benefit from a social security scheme
Who cannot join
- Termination of pregnancy or non-progressive pregnancy
- Prematurity of the child (Childbirth before 37 weeks)
- Maternal pathologies acquired during pregnancy
- Fetal diseases acquired during pregnancy
- Pregnancy of twins or triplets
- Any type of medical difficulties occurring during pregnancy (gestational diabetes, high blood pressure, threat of preterm delivery, preeclampsia, ...)
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- Any type of difficulty occurring during childbirth for example, hemorrhage of maternal deliverance
- Birth by cesarean section Birth necessitating the use of instruments that led to the transfer of the baby to the neonatology unit or to the kangaroo unit
- At birth, baby's Apgar less than 7.
- Fetal death
- Childbirth that did not occur at the CHU maternity ward
Trial locations and contacts
1 site in 1 country.
Pointurier Mathilde contact
France1 site, 1 recruiting
- Recruiting
Mathilde Pointurier
Besançon, Franche Comté, 25000
Mathilde Pointurier, 0647228661, mathildep718@gmail.com
About this study
Official title: Access to Maternity and Risk Factors in a Non-consultant Population - Longitudinal and Prospective Exploratory Study (PROXIMA)
Characterize the psychic and medical disorders related to pregnancy and motherhood in a group of primiparous and primigratic women.
- Conditions
- Post Partum Depression
- Being tested
- Psychological investigation
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological investigationOther
Psychological tests, psychological interviews.
| Study group | Role | What they receive |
|---|---|---|
| Psychological investigation | Not described Receives: Other: Psychological investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
units (scale)
Measured: 3 to 4 months of pregnancy
Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
units (scale)
Measured: 8-9 months of pregnancy
Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
units (scale)
Measured: 15 days to 1 month after birth
Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
units (scale)
Measured: 3 months after birth
Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
units (scale)
Measured: 6 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Jul 2019
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum DepressionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mottet Nicolas, Dr, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506489
- Sponsor's protocol ID
- P/2019/434
- Status last verified
- Apr 2020
- First submitted
- 20 Jul 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access to Maternity and Risk Factors in a Non-consultant Population - Longitudinal and Prospective Exploratory Study (PROXIMA)
- ClinicalTrials.gov ID
- NCT04506489
- Acronym / sponsor ID
- P/2019/434
- Conditions
- Post Partum Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 10 Aug 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.
Characterize the psychic and medical disorders related to pregnancy and motherhood in a group of primiparous and primigratic women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychological investigation | – | Other: Psychological investigation |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Primiparous women without mental and obstetric disorders monitoring in the Besançon University Hospital, during their pregnancy and after their birth.
Key inclusion criteria (9 listed)
- primiparous and primigest women,
- Singleton pregnancy
- Consultant at the University Hospital of Besançon in gynecology / obstetrics department - initial consultation
- 25 to 45 years old,
- European culture and speaking French,
Key exclusion criteria (11 listed)
- Termination of pregnancy or non-progressive pregnancy
- Prematurity of the child (Childbirth before 37 weeks)
- Maternal pathologies acquired during pregnancy
- Fetal diseases acquired during pregnancy
- Pregnancy of twins or triplets
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 |
|---|---|---|
| Psychological investigationPsychological tests, psychological interviews. | Other | Psychological investigation |
Primary outcome
Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
Time frame: 3 to 4 months of pregnancy
units (scale)
Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
Time frame: 8-9 months of pregnancy
units (scale)
Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
Time frame: 15 days to 1 month after birth
units (scale)
Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
Time frame: 3 months after birth
units (scale)
Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
Time frame: 6 months after birth
units (scale)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
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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.
Pointurier Mathilde contact
Mottet Nicolas, Dr principal investigator
CHU Besançon
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 Post Partum Depression, run by Centre Hospitalier Universitaire de Besancon 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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 10 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Belot Rose Angélique, MCF (0680188113, rose-angelique.belot@univ-fcomte.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience (time frame: 3 to 4 months of pregnancy). The study lists 5 primary outcomes in all. 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 10 Aug 2020.