Evaluation of the Psychological Consequences of Complicated Childbirth (ESPT Obst)

March 2, 2020 updated by: Rennes University Hospital
Prospective, non-interventional, monocentric, case-control study

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

256

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Britanny
      • Rennes, Britanny, France, 35000
        • Hospital-University Psychiatry Center for Children and Adolescents

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who gave birth between 01/01/2015 and 31/12/2017

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-traumatic stress
Time Frame: Baseline
Post traumatic stress state score according to the PCL-5 (Posttraumatic Stress Disorder Checklist-5)
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tocophobia
Time Frame: Baseline
Tocophobia score according to the Tocophobia Questionnaire
Baseline
Peritraumatric dissociation
Time Frame: Baseline
Peritraumatric dissociation score according to the PDEQ (Peritraumatric dissociative Expériences Questionnaire)
Baseline
Postpartum depression
Time Frame: Baseline
Postpartum depression score according to the Edingburgh Perinatal Depression Questionnaire
Baseline
Mother-child relationship
Time Frame: Baseline
Mother-child Relationship score according to the Parent Bonding Questionnaire
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 23, 2018

Primary Completion (ACTUAL)

February 27, 2020

Study Completion (ACTUAL)

February 27, 2020

Study Registration Dates

First Submitted

February 15, 2018

First Submitted That Met QC Criteria

February 15, 2018

First Posted (ACTUAL)

February 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 35RC18_3096_ESPT Obst

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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