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

Post Partum Depression Clinical Trial

Official title:

Access to Maternity and Risk Factors in a Non-consultant Population - Longitudinal and Prospective Exploratory Study (PROXIMA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04506489
• Other study ID #: P/2019/434
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: April 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Belot Rose Angélique, MCF
• Phone: 0680188113
• Email: rose-angelique.belot[@]univ-fcomte.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression, Postpartum
• Post Partum Depression

Intervention

Other:
• Psychological investigation
Psychological tests, psychological interviews.

Locations

Country	Name	City	State
France	Mathilde Pointurier	Besançon	Franche Comté

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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