NCT03791021

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

1.4 years

First QC Date

December 29, 2018

Last Update Submit

June 7, 2020

Conditions

Keywords

postpartum, depression, self portraits

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

third trimester pregnant women

the group of participants in this research would include approximately 100 subjects in the third trimester of their pregnancy. the participants would be collected in the central area of Israel from various socioeconomic groups. each participant would be asked to make draw a person (DAP) test, and answer a number of questionnaires including Edinburgh Postnatal Depression Scale (EPDS), Beck Depression Inventory II (BDI-II), and Traumatic Events Questionnaire (TEQ).

Diagnostic Test: draw a person (DAP)Diagnostic Test: Edinburgh Postnatal Depression Scale (EPDS)Diagnostic Test: Beck Depression Inventory- II (BDI-II)Diagnostic Test: Traumatic Events Questionnaire (TEQ)

Interventions

draw a person (DAP)DIAGNOSTIC_TEST

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.

third trimester pregnant women

measure of postpartum depression symptoms.

third trimester pregnant women

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.

third trimester pregnant women

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.

third trimester pregnant women

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

100 pregnant women

You may qualify if:

  • third trimester pregnant women

You may not qualify if:

  • pregnant women with established diagnosis of mental disorders
  • still birth or intra uterine disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aya Mohr Sasson

Ramat Gan, Please Select, 52621, Israel

Location

MeSH Terms

Conditions

Depression, PostpartumDepression

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 29, 2018

First Posted

January 2, 2019

Study Start

January 1, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Locations