Clinical trial NCT04080141: Therapeutic Termination of Pregnancy and Psychiatric Implications
Official title: Therapeutic Termination of Pregnancy: Maternal and Paternal Mental Health Before and in the Long-term
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 90
Sex: ALL
Minimum age (years): 10
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Depressive symptoms in women
timeFrame: 1 year
measure: Post-traumatic stress disorder in women
timeFrame: 1 year
Secondary outcomes:
measure: Depressive symptoms after TToP in men
timeFrame: 1 year
measure: Post-traumatic stress disorder after TToP in men
timeFrame: 1 year
measure: Participants with personality disorder
timeFrame: 1 year
measure: Participants with childhood trauma
timeFrame: 1 year
measure: Role of personality disorders on depressive symptoms after TToP
timeFrame: 1 year
measure: Role of personality disorders on post-traumatic symptoms after TToP
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
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