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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03791021
Other study ID # 5651-18-SMC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date June 1, 2020

Study information

Verified date June 2020
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

the target of the research is development of a predictive tool for early identification of women which are at higher risk for development of postpartum depression.

the evaluating tools include self portraits and questionnaire during the third trimester of pregnancy.

The suggested research aims to evaluate if and how it would be possible to predict the potential for postpartum mood swing disorders in pregnant women while in the third trimester. The later to prevent the mother from enduring such a detrimental experience, which influences the child development, the family as well as the mother's intimate relationship.

The aim is to identify indicators to predict such potential, using questionnaires and self-portraits during pregnancy, to allow early intervention and treatment. Early diagnosis and quick treatment of pregnant women or post-partum mothers will allow them a higher level of functioning and may even prevent eventually infant neurological and developmental delays and hardships.


Description:

the target of the research is to evaluate a method based on self portraits and targeted questionnaire done in the third trimester and three months later in order to identify pregnant women in higher risk to develop PPD.

the minimal number of objectives participating in the research would be 100 pregnant women during the third trimester of pregnancy.

the Draw A Person (DAP) test was described by Machover in 1949. it is still considered a reliable and well recognized test for evaluation of mental stress and disorders (Gilory, 2012).

in the research approximately 100 pregnant women in the third trimester would be asked to draw a self portrait in two different time points (during the third trimester and three to six months postpartum). in addition to the self portraits the participants would be asked to fill a set of questionnaires to evaluate the degree of depression, self esteem, personal history of traumatic events, and demographic data.

the self portraits would be evaluated by three judges. the reliability between judges would be tested using KAPPA test.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- third trimester pregnant women

Exclusion Criteria:

- pregnant women with established diagnosis of mental disorders

- still birth or intra uterine disorders

Study Design


Intervention

Diagnostic Test:
draw a person (DAP)
the subjects will be given a blank sheet of white paper and a pencil, and will be asked to draw themselves with no other additional instructions.
Edinburgh Postnatal Depression Scale (EPDS)
measure of postpartum depression symptoms.
Beck Depression Inventory- II (BDI-II)
BDI-II is based on clinical observations of behaviors associated with depression, and it retains the somatic items in accordance with the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria related to loss of energy. ansd sleep disturbances.
Traumatic Events Questionnaire (TEQ)
The TEQ assesses experiences with nine specific types of traumatic events (e.g., accidents, crime, adult abusive experiences) reported in the empirical literature as having the potential to elicit PTSD symptoms.

Locations

Country Name City State
Israel Aya Mohr Sasson Ramat -Gan Please Select

Sponsors (2)

Lead Sponsor Collaborator
Sheba Medical Center University of Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary development of a reliable projective tool for prediction of PPD ratification of a projective tool using self portrait tests to identify patient at risk for developing PPD one year
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