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

• Conditions: Post Partum Depression
• Interventions: Other: Psychological investigation

• Registration Number: NCT04506489
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Status Verified: 2020-04
• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-08-06
• Last Update Submitted: 2020-08-06
• Study First Posted: 2020-08-10
• Last Update Posted: 2020-08-10
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Psychological investigation	Psychological investigation	-

Primary Outcome Measures

Name	Time	Method
Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience	6 months after birth	units (scale)

Trial Locations

Locations (1)

Mathilde Pointurier; 🇫🇷 Besançon, Franche Comté, France