Therapeutic Termination of Pregnancy and Psychiatric Implications (TTOP_PSY)

September 5, 2019 updated by: University of Milano Bicocca

Therapeutic Termination of Pregnancy: Maternal and Paternal Mental Health Before and in the Long-term

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The therapeutic interruption of pregnancy (TTOP) may have psychiatric outcomes like depression, anxiety and post-traumatic stress disorder (PTSD). Personality issues, childhood traumas and paternal consequences are too little investigated in current Literature.

The investigator's aim is exploring the contribution of maternal personality disorders and maternal history of childhood traumas to psychiatric outcomes after a TToP, paternal psychiatric outcomes and their role on their partner's psychopathological and psychiatric outcomes.

25 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).

At the time of first contact (T0) only women were subjected to a psychiatric clinical examination in order to evaluate their legal eligibility to TToP, according to Italian Law n. 194/78. At T0 women were also 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) the parental couples 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).

Study Type

Observational

Enrollment (Actual)

90

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Incapacity
  • Acute psychosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PD+
Subjects with personality disorder
Diagnostic test: Multiple psychometric questionnaire
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).
Procedure: Clinical psychiatric examination
At the time of first contact (T0) only women were subjected to psychiatric clinical examination
PD-
Subjects without personality disorder
Diagnostic test: Multiple psychometric questionnaire
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).
Procedure: Clinical psychiatric examination
At the time of first contact (T0) only women were subjected to psychiatric clinical examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms in women
Time Frame: 1 year
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
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms after TToP in men
Time Frame: 1 year
Change from Baseline in number of men 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 after TToP in men
Time Frame: 1 year
Change from Baseline in number of men with post-traumatic symptoms at 1 year after TToP assessed with the PTSD Checklist 5 (PCL-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
Participants with personality disorder
Time Frame: 1 year
Number of participants with personality disorder assessed with the Iowa Personality Disorder Screen, which is a 11-item screening instrument used to evaluate the presence of a personality disorder. Each item is scored dichotomously by Yes/No, giving individual IPDS scores ranging from 0 to 11. A cut off>4 positive items indicates the presence of a personality disorder. A higher value represent a worse outcome
1 year
Participants with childhood trauma
Time Frame: 1 year
Number of participants with a childhood trauma assessed with the Childhood Trauma Questionnaire, which is a standardized, retrospective 28-item self-report inventory that measures the severity of different types of childhood trauma, producing five clinical subscales each comprised of five items: Emotional Abuse, Physical Abuse, Sexual Abuse, Emotional Neglect, Physical Neglect. Participants respond to each item in the context of "when you were growing up" and answer according to a five-point Likert scale ranging from "never" = 1 to "very often" = 5, producing scores of 5 to 25 for each trauma subscale. A cut off>5 points in every subscale indicates the presence of that particular traumatic experience. A higher score in every subscale represent a worse outcome and a more severe type of childhood trauma
1 year
Role of personality disorders on depressive symptoms after TToP
Time Frame: 1 year
Difference in number of patients with depressive symptoms assessed with the Beck Depression Inventory (BDI, previously described) between participants with a personality disorder (PD+ group) and participants without a personality disorder (PD- group). This difference will be assessed with a statistical analysis. A higher number of patients with depressive symptoms in one of the two groups represent a worse outcome in that group
1 year
Role of personality disorders on post-traumatic symptoms after TToP
Time Frame: 1 year
Difference in number of patients with post-traumatic symptoms assessed with the PTSD Checklist 5 (PCL-5, previously described) between participants with a personality disorder (PD+ group) and participants without a personality disorder (PD- group). This difference will be assessed with a statistical analysis. A higher number of patients with post-traumatic symptoms in one of the two groups represent a worse outcome in that group
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

July 25, 2019

Study Registration Dates

First Submitted

July 26, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 5, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 981/b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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