Therapeutic Termination of Pregnancy and Psychiatric Implications

NCT04080141 | Completed

• 1 other identifier: 981/b
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

25 parental couples, with a prenatal diagnosis of fetal abnormality, had psychiatric evaluation for eligibility before TToP and after one year from the procedure. Women and unborn's fathers were also subjected to different psychometric questionnaires (HAM-D, HAM-A, BDI-II, PCL-5, IPDS, CTQ, CD-RISC-10).

Conditions

Therapeutic Abortion With Complications; Personality Disorders; Trauma, Psychological; Reproductive Behavior; Post Traumatic Stress Disorder; Depression, Reactive

Keywords

Therapeutic Abortion; Personality Disorders; Childhood Trauma; Post Traumatic Stress Disorder; Depression

Outcome Measures

Primary Outcomes (2)

• Depressive symptoms in women

  Change from Baseline in number of women with depressive symptoms at 1 year after TToP assessed with the Beck Depression Inventory, which measure the severity of depressive symptoms. The long form of the Beck Depression Inventory is composed of 21 questions or items, each with four possible responses. Each response is assigned a score ranging from zero to three, indicating the severity of the symptom. The sum of all item scores indicates the severity of depression. Scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression. So, a higher value at the Beck Depression Inventory represent a worse outcome.

  1 year

• Post-traumatic stress disorder in women

  Change from Baseline in number of women with post-traumatic symptoms at 1 year after TToP assessed with the PTSD Checklist 5, which is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. PCL-5 cut-point of 33 appears to be a reasonable value to use for provisional PTSD diagnosis. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80 and a higher value represent a worse outcome

  1 year

Secondary Outcomes (6)

• Depressive symptoms after TToP in men

  1 year

• Post-traumatic stress disorder after TToP in men

  1 year

• Participants with personality disorder

  1 year

• Participants with childhood trauma

  1 year

• Role of personality disorders on depressive symptoms after TToP

  1 year

Study Arms (2)

PD+

Subjects with personality disorder

Diagnostic Test: Multiple psychometric questionnaire; Procedure: Clinical psychiatric examination

PD-

Subjects without personality disorder

Diagnostic Test: Multiple psychometric questionnaire; Procedure: Clinical psychiatric examination

Interventions

Multiple psychometric questionnaire DIAGNOSTIC_TEST

At the time of first contact (T0) only women were subjected to Hamilton's rating scale for depression (HRSD or HAM-D), Hamilton's rating scale for anxiety (HRSA or HAM-A), Beck Depression Inventory (BDI-II). At the follow up after 1 year from the first examination (T1) they were subjected to a questionnaire with multiple psychometric tests for mother and her partner. The female version included Post-traumatic stress disorder checklist (PCL-5), Iowa Personality Disorder Screen (IPDS), Beck Depression Inventory (BDI-II), Connor-Davidson Resilience Scale 10 (CD-RISC 10) and Short-Form Questionnaire on childhood trauma (CTQ-SF). The male version included Post-traumatic stress disorder checklist (PCL-5), Iowa Personality Disorder Screen (IPDS), Connor-Davidson Resilience Scale 10 (CD-RISC 10) and Short-Form Questionnaire on childhood trauma (CTQ-SF).

PD+; PD-

Clinical psychiatric examination PROCEDURE

At the time of first contact (T0) only women were subjected to psychiatric clinical examination

PD+; PD-

Eligibility Criteria

• Age: 10 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

45 parental couples (90 subjects: 45 women and 45 men) with a prenatal diagnosis of fetral abnormality followed by Obstetrical Department of ASST Monza

You may qualify if:

• Pregnancy
• Prenatal diagnosis of fetal abnormality
• Adequate comprehension
• Legal eligibility to TToP procedure after psychiatric clinical evaluation
• Acceptance on a voluntary basis

You may not qualify if:

• Incapacity
• Acute psychosis

Sponsors & Collaborators

• University of Milano Bicocca: lead

Related Publications (27)

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MeSH Terms

Conditions

Personality Disorders; Psychological Trauma; Reproductive Behavior; Stress Disorders, Post-Traumatic; Adjustment Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Behavior; Behavioral Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: September 6, 2019
• Study Start: January 1, 2012
• Primary Completion: December 31, 2016
• Study Completion: July 25, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09