Clinical trial NCT04506489: Access to Maternity and Risk Factors in a Non-consultant Population (PROXIMA)
Official title: Access to Maternity and Risk Factors in a Non-consultant Population - Longitudinal and Prospective Exploratory Study (PROXIMA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Partum Depression
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 500
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primiparous women without mental and obstetric disorders monitoring in the Besançon University Hospital, during their pregnancy and after their birth.

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


Eligibility criteria: 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

Primary outcomes:
measure: Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
timeFrame: 3 to 4 months of pregnancy
measure: Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
timeFrame: 8-9 months of pregnancy
measure: Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
timeFrame: 15 days to 1 month after birth
measure: Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
timeFrame: 3 months after birth
measure: Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
timeFrame: 6 months after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Mathilde Pointurier
state: Franche Comté
Study officials:
affiliation: CHU Besançon
name: Mottet Nicolas, Dr
role: PRINCIPAL_INVESTIGATOR
References: