Therapeutic Termination of Pregnancy and Psychiatric Implications

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

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

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

Intervention / Treatment
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* Diagnostic Test: Multiple psychometric questionnaire
* Procedure: Clinical psychiatric examination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PD+<br>Subjects with personality disorder | Diagnostic Test: Multiple psychometric questionnaire<br>* 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).<br>Procedure: Clinical psychiatric examination<br>* At the time of first contact (T0) only women were subjected to psychiatric clinical examination<br>|
| PD-<br>Subjects without personality disorder | Diagnostic Test: Multiple psychometric questionnaire<br>* 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).<br>Procedure: Clinical psychiatric examination<br>* At the time of first contact (T0) only women were subjected to psychiatric clinical examination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms after TToP in men | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic Abortion, Personality Disorders, Childhood Trauma, Post Traumatic Stress Disorder, Depression