NCT03441243

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 23, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2020

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

February 15, 2018

Last Update Submit

March 2, 2020

Conditions

Parturition

Outcome Measures

Primary Outcomes (1)

  • Post-traumatic stress

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

    Baseline

Secondary Outcomes (4)

  • Tocophobia

    Baseline

  • Peritraumatric dissociation

    Baseline

  • Postpartum depression

    Baseline

  • Mother-child relationship

    Baseline

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital-University Psychiatry Center for Children and Adolescents

Rennes, Britanny, 35000, France

Location

Study Officials

  • Jacques Dayan

    Hospital-University Psychiatry Center for Children and Adolescents

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2018

First Posted

February 22, 2018

Study Start

May 23, 2018

Primary Completion

February 27, 2020

Study Completion

February 27, 2020

Last Updated

March 3, 2020

Record last verified: 2020-03

Locations

FR(1)