Evaluation of the Psychological Consequences of Complicated Childbirth

Parturition Clinical Trial

— ESPT Obst  

Official title:

Evaluation of the Psychological Consequences of Complicated Childbirth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441243
• Other study ID #: 35RC18_3096_ESPT Obst
• Status: Completed
• Start date: May 23, 2018
• Est. completion date: February 27, 2020

Study information

• Verified date: March 2020
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: February 27, 2020
• Est. primary completion date: February 27, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parturition

Locations

Country	Name	City	State
France	Hospital-University Psychiatry Center for Children and Adolescents	Rennes	Britanny

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-traumatic stress	Post traumatic stress state score according to the PCL-5 (Posttraumatic Stress Disorder Checklist-5)	Baseline
Secondary	Tocophobia	Tocophobia score according to the Tocophobia Questionnaire	Baseline
Secondary	Peritraumatric dissociation	Peritraumatric dissociation score according to the PDEQ (Peritraumatric dissociative Expériences Questionnaire)	Baseline
Secondary	Postpartum depression	Postpartum depression score according to the Edingburgh Perinatal Depression Questionnaire	Baseline
Secondary	Mother-child relationship	Mother-child Relationship score according to the Parent Bonding Questionnaire	Baseline