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OpenTrials
Completed

NCT Number: NCT03441243

Evaluation of the Psychological Consequences of Complicated Childbirth

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

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital-University Psychiatry Center for Children and Adolescents

Rennes, Britanny, 35000, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Post-traumatic stress

    Time frame: Baseline

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

Secondary outcomes

  1. Tocophobia

    Time frame: Baseline

    Tocophobia score according to the Tocophobia Questionnaire

  2. Peritraumatric dissociation

    Time frame: Baseline

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

  3. Postpartum depression

    Time frame: Baseline

    Postpartum depression score according to the Edingburgh Perinatal Depression Questionnaire

  4. Mother-child relationship

    Time frame: Baseline

    Mother-child Relationship score according to the Parent Bonding Questionnaire

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: ESPT Obst

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 22, 2018
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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