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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04506489
Other study ID # P/2019/434
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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