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

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ClinicalTrials.gov Identifier: NCT03441243
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
Prospective, non-interventional, monocentric, case-control study

Condition or disease
Parturition

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
Estimated 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
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Childbirth

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.



Primary Outcome Measures :
  1. Post-traumatic stress [ Time Frame: Baseline ]
    Post traumatic stress state score according to the PCL-5 (Posttraumatic Stress Disorder Checklist-5)


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who gave birth between 01/01/2015 and 31/12/2017
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441243


Contacts
Contact: Jacques Dayan 299510604 ext +33 jcdayan@gmail.com
Contact: Isabelle Enderle isaenderle@orange.fr

Locations
France
Hospital-University Psychiatry Center for Children and Adolescents Recruiting
Rennes, Britanny, France, 35000
Contact: Jacques Dayan    299510604 ext +33    jcdayan@gmail.com   
Contact: Isabelle Enderle       isaenderle@orange.fr   
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Jacques Dayan Hospital-University Psychiatry Center for Children and Adolescents

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03441243     History of Changes
Other Study ID Numbers: 35RC18_3096_ESPT Obst
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No