Access to Maternity and Risk Factors in a Non-consultant Population (PROXIMA)

NCT ID: NCT04506489

Last Updated: 2020-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-01-01

Brief Summary

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Characterize the psychic and medical disorders related to pregnancy and motherhood in a group of primiparous and primigratic women.

Detailed Description

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Conditions

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Post Partum Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Psychological investigation

Psychological investigation

Intervention Type OTHER

Psychological tests, psychological interviews.

Interventions

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Psychological investigation

Psychological tests, psychological interviews.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
* 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

Exclusion Criteria

* 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, ...)
* 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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mottet Nicolas, Dr

Role: PRINCIPAL_INVESTIGATOR

CHU Besançon

Locations

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Mathilde Pointurier

Besançon, Franche Comté, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Belot Rose Angélique, MCF

Role: CONTACT

0680188113

Pointurier Mathilde

Role: CONTACT

Facility Contacts

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Mathilde Pointurier

Role: primary

0647228661

Other Identifiers

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P/2019/434

Identifier Type: -

Identifier Source: org_study_id

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