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Therapeutic Abortion With ComplicationsTTOP_PSYNCT04080141

Therapeutic Termination of Pregnancy and Psychiatric Implications

An observational study of Therapeutic Abortion With Complications and Personality Disorders, run by University of Milano Bicocca.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 10 to 99 years
What is being tested?
Multiple psychometric questionnaire and Clinical psychiatric examination
Type of treatment
Surgery or procedure
How many people
90 participants
Where
No sites listed yet
Study dates
1 Jan 2012to 25 Jul 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Incapacity
  • Acute psychosis

About this study

Official title: 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).

Read the 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).

Being tested
Multiple psychometric questionnaire, Clinical psychiatric examination
Keywords
Therapeutic Abortion, Personality Disorders, Childhood Trauma, Post Traumatic Stress Disorder, Depression
Medical subject headings
Personality Disorders, Psychological Trauma, Reproductive Behavior, Stress Disorders, Post-Traumatic, Adjustment Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multiple psychometric questionnaireDiagnostic 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).

  • Clinical psychiatric examinationProcedure or surgery

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

Study groups in NCT04080141
Study groupRoleWhat they receive
PD+Subjects with personality disorder
Receives: Diagnostic Test: Multiple psychometric questionnaire; Procedure: Clinical psychiatric examination
PD-Subjects without personality disorder
Receives: Diagnostic Test: Multiple psychometric questionnaire; Procedure: Clinical psychiatric examination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

  2. 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

    Measured: 1 year

Secondary outcomes (6)

  1. 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.

    Measured: 1 year

  2. 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

    Measured: 1 year

  3. 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

    Measured: 1 year

  4. 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

    Measured: 1 year

  5. 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

    Measured: 1 year

  6. 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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2019
  2. Study start1 Jan 2012
  3. Primary completion31 Dec 2016
  4. Study completion25 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04080141
Sponsor's protocol ID
981/b
Acronym
TTOP_PSY
Status last verified
Sep 2019
First submitted
26 Jul 2019
Last updated
6 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Rasch V, Gammeltoft T, Knudsen LB, Tobiassen C, Ginzel A, Kempf L. Induced abortion in Denmark: effect of socio-economic situation and country of birth. Eur J Public Health. 2008 Apr;18(2):144-9. doi: 10.1093/eurpub/ckm112. Epub 2007 Dec 7.

    PubMed 18065434

  • Uria M, Mosquera C. Legal abortion in Asturias (Spain) after the 1985 law: sociodemographic characteristics of women applying for abortion. Eur J Epidemiol. 1999 Jan;15(1):59-64. doi: 10.1023/a:1007541904470.

    PubMed 10098997

  • Dehlendorf C, Harris LH, Weitz TA. Disparities in abortion rates: a public health approach. Am J Public Health. 2013 Oct;103(10):1772-9. doi: 10.2105/AJPH.2013.301339. Epub 2013 Aug 15.

    PubMed 23948010

  • Taft AJ, Watson LF. Termination of pregnancy: associations with partner violence and other factors in a national cohort of young Australian women. Aust N Z J Public Health. 2007 Apr;31(2):135-42. doi: 10.1111/j.1753-6405.2007.00031.x.

    PubMed 17461004

  • Dehlendorf C, Weitz T. Access to abortion services: a neglected health disparity. J Health Care Poor Underserved. 2011 May;22(2):415-21. doi: 10.1353/hpu.2011.0064.

    PubMed 21551921

  • Perez G, Ruiz-Munoz D, Gotsens M, Cases MC, Rodriguez-Sanz M. Social and economic inequalities in induced abortion in Spain as a function of individual and contextual factors. Eur J Public Health. 2014 Feb;24(1):162-9. doi: 10.1093/eurpub/ckt104. Epub 2013 Jul 31.

    PubMed 23902666

  • Taft AJ, Watson LF, Lee C. Violence against young Australian women and association with reproductive events: a cross-sectional analysis of a national population sample. Aust N Z J Public Health. 2004 Aug;28(4):324-9. doi: 10.1111/j.1467-842x.2004.tb00438.x.

    PubMed 15704695

  • Major B, Appelbaum M, Beckman L, Dutton MA, Russo NF, West C. Abortion and mental health: Evaluating the evidence. Am Psychol. 2009 Dec;64(9):863-90. doi: 10.1037/a0017497.

    PubMed 19968372

  • Steinberg JR, Finer LB. Examining the association of abortion history and current mental health: A reanalysis of the National Comorbidity Survey using a common-risk-factors model. Soc Sci Med. 2011 Jan;72(1):72-82. doi: 10.1016/j.socscimed.2010.10.006. Epub 2010 Oct 23.

    PubMed 21122964

  • Mota NP, Burnett M, Sareen J. Associations between abortion, mental disorders, and suicidal behaviour in a nationally representative sample. Can J Psychiatry. 2010 Apr;55(4):239-47. doi: 10.1177/070674371005500407.

    PubMed 20416147

  • Munk-Olsen T, Laursen TM, Pedersen CB, Lidegaard O, Mortensen PB. First-time first-trimester induced abortion and risk of readmission to a psychiatric hospital in women with a history of treated mental disorder. Arch Gen Psychiatry. 2012 Feb;69(2):159-65. doi: 10.1001/archgenpsychiatry.2011.153.

    PubMed 22310504

  • van Ditzhuijzen J, ten Have M, de Graaf R, van Nijnatten CH, Vollebergh WA. Psychiatric history of women who have had an abortion. J Psychiatr Res. 2013 Nov;47(11):1737-43. doi: 10.1016/j.jpsychires.2013.07.024. Epub 2013 Aug 12.

    PubMed 23941742

  • Wallin Lundell I, Sundstrom Poromaa I, Frans O, Helstrom L, Hogberg U, Moby L, Nyberg S, Sydsjo G, Georgsson Ohman S, Ostlund I, Skoog Svanberg A. The prevalence of posttraumatic stress among women requesting induced abortion. Eur J Contracept Reprod Health Care. 2013 Dec;18(6):480-8. doi: 10.3109/13625187.2013.828030. Epub 2013 Aug 26.

    PubMed 23978220

  • Simoila L, Isometsa E, Gissler M, Suvisaari J, Sailas E, Halmesmaki E, Lindberg N. Schizophrenia and induced abortions: A national register-based follow-up study among Finnish women born between 1965-1980 with schizophrenia or schizoaffective disorder. Schizophr Res. 2018 Feb;192:142-147. doi: 10.1016/j.schres.2017.05.039. Epub 2017 Jun 12.

    PubMed 28615119

  • O'Brien KM, Whelan DR, Sandler DP, Hall JE, Weinberg CR. Predictors and long-term health outcomes of eating disorders. PLoS One. 2017 Jul 10;12(7):e0181104. doi: 10.1371/journal.pone.0181104. eCollection 2017.

    PubMed 28700663

Questions about this trial

What is this clinical trial studying?

An observational study of Therapeutic Abortion With Complications and Personality Disorders, run by University of Milano Bicocca.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depressive symptoms in women (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04080141, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.

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