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

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.

Study Overview

• Status: Unknown
• Conditions: Post Partum Depression
• Intervention / Treatment: Other: Psychological investigation

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Belot Rose Angélique, MCF; Phone Number: 0680188113; Email: rose-angelique.belot@univ-fcomte.fr
• Study Contact Backup: Name: Pointurier Mathilde; Email: mathilde.pointurier@edu.univ-fcomte.fr

Study Locations

• France
  • Franche Comté
    • Besançon, Franche Comté, France, 25000
      • Recruiting
      • Mathilde Pointurier
      • Contact: Mathilde Pointurier; Phone Number: 0647228661; Email: mathildep718@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Psychological investigation	Other: Psychological investigation; Psychological tests, psychological interviews.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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)	6 months after birth

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Mottet Nicolas, Dr, CHU Besançon

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (ACTUAL): August 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: P/2019/434

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No