Clinical Trials Directory

Trials / Completed

CompletedNCT04080141

Therapeutic Termination of Pregnancy and Psychiatric Implications

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

Status
Completed
Phase
Study type
Observational
Enrollment
90 (actual)
Sponsor
University of Milano Bicocca · Academic / Other
Sex
All
Age
10 Years – 99 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTMultiple psychometric questionnaireAt 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).
PROCEDUREClinical psychiatric examinationAt the time of first contact (T0) only women were subjected to psychiatric clinical examination

Timeline

Start date
2012-01-01
Primary completion
2016-12-31
Completion
2019-07-25
First posted
2019-09-06
Last updated
2019-09-06

Source: ClinicalTrials.gov record NCT04080141. Inclusion in this directory is not an endorsement.