ESPT Obst: Evaluation of the Psychological Consequences of Complicated Childbirth

Sponsor
Rennes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03441243
Collaborator
(none)
256
1
21.2
12.1

Study Details

Study Description

Brief Summary

Prospective, non-interventional, monocentric, case-control study

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The post-traumatic stress state affects up to 6.2% of patients at 2 months post partum.

    Emergency cesarean section and rescue hemorrhage are identified risk factors for postpartum stress disorder or postpartum depression.

    These complications (emergency cesarean section and hemorrhage of delivery) alter the mother-child relationship and cognitive development of the child.

    The experience of an emergency Cesarean section or a haemorrhage of deliverance generates apprehension about a subsequent pregnancy. Some patients abandon a future pregnancy project for fear of reliving these experiences.

    Currently, at the southern hospital, the risk factors for developing a state of post-traumatic stress are not sought by the care teams. No specific follow-up is planned for patients who have had an emergency caesarean section or hemorrhage of delivery.

    The investigators wish to study the psychological consequences of emergency cesarean section and rescue haemorrhage, the risk factors for post-traumatic stress disorder after emergency cesarean section or hemorrhage of delivery, and their consequences on the mother-child relationship to better identify situations at risk of psychological trauma and provide appropriate care for patients (consultation with a postpartum psychologist).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    256 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of the Psychological Consequences of Complicated Childbirth
    Actual Study Start Date :
    May 23, 2018
    Actual Primary Completion Date :
    Feb 27, 2020
    Actual Study Completion Date :
    Feb 27, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Case group:Cesarean section urgently

    - 43 patients had an emergency caesarean section between 01/01/2015 and 31/12/2016.

    Case group:Hemorrhage of deliverance

    - 85 patients had haemorrhage of the delivery with need for a transfusion between 01/01/2015 and 31/12/2017.

    Control group: delivery physiological low path

    - A control group will consist of 128 patients who had a physiological low birth delivery over the same period.

    Outcome Measures

    Primary Outcome Measures

    1. Post-traumatic stress [Baseline]

      Post traumatic stress state score according to the PCL-5 (Posttraumatic Stress Disorder Checklist-5)

    Secondary Outcome Measures

    1. Tocophobia [Baseline]

      Tocophobia score according to the Tocophobia Questionnaire

    2. Peritraumatric dissociation [Baseline]

      Peritraumatric dissociation score according to the PDEQ (Peritraumatric dissociative Expériences Questionnaire)

    3. Postpartum depression [Baseline]

      Postpartum depression score according to the Edingburgh Perinatal Depression Questionnaire

    4. Mother-child relationship [Baseline]

      Mother-child Relationship score according to the Parent Bonding Questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Major patients ;

    • Who had hemorrhage of the transfused delivery between 01/01/2015 and 31/12/2017 or an emergency cesarean section between 01/01/2015 and 31/12/2016 or patients who gave birth physiologically paired with age, date of delivery and parity ;

    • Patients who did not express their opposition to participate in the study.

    Exclusion Criteria:
    • Minor patients;

    • Patients who do not speak and understand French;

    • Major persons subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital-University Psychiatry Center for Children and Adolescents Rennes Britanny France 35000

    Sponsors and Collaborators

    • Rennes University Hospital

    Investigators

    • Principal Investigator: Jacques Dayan, Hospital-University Psychiatry Center for Children and Adolescents

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rennes University Hospital
    ClinicalTrials.gov Identifier:
    NCT03441243
    Other Study ID Numbers:
    • 35RC18_3096_ESPT Obst
    First Posted:
    Feb 22, 2018
    Last Update Posted:
    Mar 3, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 3, 2020