NCT04506489

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

August 10, 2020

Status Verified

April 1, 2020

Enrollment Period

1.5 years

First QC Date

July 20, 2020

Last Update Submit

August 6, 2020

Conditions

Post Partum Depression

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

Psychological investigation

Other: Psychological investigation

Interventions

Psychological investigationOTHER

Psychological tests, psychological interviews.

Psychological investigation

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Primiparous women without mental and obstetric disorders monitoring in the Besançon University Hospital, during their pregnancy and after their birth.

You may qualify if:

  • primiparous and primigest women,
  • Singleton pregnancy
  • Consultant at the University Hospital of Besançon in gynecology / obstetrics department - initial consultation
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mathilde Pointurier

Besançon, Franche Comté, 25000, France

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Mottet Nicolas, Dr

    CHU Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Belot Rose Angélique, MCF

CONTACT

0680188113rose-angelique.belot@univ-fcomte.fr

Pointurier Mathilde

CONTACT

mathilde.pointurier@edu.univ-fcomte.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2020

First Posted

August 10, 2020

Study Start

July 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

August 10, 2020

Record last verified: 2020-04

Locations

FR(1)