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The Effect of Traumatic Childbirth on the Incidence of PTSD and Other Major Postpartum Psychopathology

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ClinicalTrials.gov Identifier: NCT02370576
Recruitment Status : Unknown
Verified February 2015 by Marina Bar-Shai, MD, PhD, Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : February 25, 2015
Last Update Posted : February 25, 2015
Sponsor:
Information provided by (Responsible Party):
Marina Bar-Shai, MD, PhD, Rambam Health Care Campus

Brief Summary:
Determination of incidence and prevalence of PTSD and other types of psychopathology (such as anxiety and affective disorders) after traumatic birth experiences and elucidation of salient risk factors in the local population sample- by prospective follow-up.

Condition or disease Intervention/treatment
Stress Disorders, Post-Traumatic Depressive Disorder, Major Other: rating scale application

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: The Effect of Traumatic Childbirth on the Incidence of Postpartum PTSD, MDD and Anxiety Disorders
Study Start Date : March 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
control
Healthy women after elective cesarean section.Questionnaire/ rating scale application. Screening: protocol designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor).
Other: rating scale application

Administration of validated PTSD, MDD and anxiety disorders rating scales immediately after birth and 1 month postpartum.

rating scale application

Other Name: rating scale

emergency
Healthy women after emergency cesarean section. Questionnaire/ rating scale application. Screening: protocol designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor).
Other: rating scale application

Administration of validated PTSD, MDD and anxiety disorders rating scales immediately after birth and 1 month postpartum.

rating scale application

Other Name: rating scale




Primary Outcome Measures :
  1. Presence or absence of PTSD (Questionnaire/ rating scale application) [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Presence or absence of major depression (Questionnaire/ rating scale application) [ Time Frame: 1 month ]
  2. Presence or absence of anxiety disorders (Questionnaire/ rating scale application) [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Either healthy women without previous psychiatric background,1-2 days after an uncomplicated planned Cesarean birth, or healthy women without previous psychiatric background, 1-2 days after an emergency Cesarean birth.
Criteria

Inclusion Criteria:

  • No psychiatric background

Exclusion Criteria:

  • Known psychiatric disorder

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): NCT02370576


Contacts
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Contact: Marina Bar-Shai, MD, PhD 972-50-2062142 m_bar-shai@rambam.health.gov.il
Contact: Arieh Drugan, Pro.f 972-50-2062006 a_drugan@rambam.health.gov.il

Locations
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Israel
Rambam Medical Center Not yet recruiting
Haifa, Israel
Contact: Marina Bar-shai, MD, PhD    972-50-2062142    m_bar-shai@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Marina Bar-Shai, MD, PhD Rambam Healthcare Center

Additional Information:

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Responsible Party: Marina Bar-Shai, MD, PhD, MD, PhD, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02370576     History of Changes
Other Study ID Numbers: rambam001
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: February 25, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Stress Disorders, Post-Traumatic
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders