Therapeutic Termination of Pregnancy and Psychiatric Implications
NCT ID: NCT04080141
Last Updated: 2019-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2012-01-01
2019-07-25
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PD+
Subjects with personality disorder
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).
Clinical psychiatric examination
At the time of first contact (T0) only women were subjected to psychiatric clinical examination
PD-
Subjects without personality disorder
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).
Clinical psychiatric examination
At the time of first contact (T0) only women were subjected to psychiatric clinical examination
Interventions
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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).
Clinical psychiatric examination
At the time of first contact (T0) only women were subjected to psychiatric clinical examination
Eligibility Criteria
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Inclusion Criteria
* Prenatal diagnosis of fetal abnormality
* Adequate comprehension
* Legal eligibility to TToP procedure after psychiatric clinical evaluation
* Acceptance on a voluntary basis
Exclusion Criteria
* Acute psychosis
10 Years
99 Years
ALL
No
Sponsors
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University of Milano Bicocca
OTHER
Responsible Party
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Roller CG. Sexually compulsive/addictive behaviors in women: a women's healthcare issue. J Midwifery Womens Health. 2007 Sep-Oct;52(5):486-91. doi: 10.1016/j.jmwh.2007.03.014.
De Genna NM, Feske U, Larkby C, Angiolieri T, Gold MA. Pregnancies, abortions, and births among women with and without borderline personality disorder. Womens Health Issues. 2012 Jul-Aug;22(4):e371-7. doi: 10.1016/j.whi.2012.05.002.
Bleil ME, Adler NE, Pasch LA, Sternfeld B, Reijo-Pera RA, Cedars MI. Adverse childhood experiences and repeat induced abortion. Am J Obstet Gynecol. 2011 Feb;204(2):122.e1-6. doi: 10.1016/j.ajog.2010.09.029. Epub 2010 Nov 11.
Niswander KR, Singer J, Singer M. Psychological reaction to therapeutic abortion. II. Objective response. Am J Obstet Gynecol. 1972 Sep 1;114(1):29-33. doi: 10.1016/0002-9378(72)90284-0. No abstract available.
Cohen L, Roth S. Coping with abortion. J Human Stress. 1984 Fall;10(3):140-5. doi: 10.1080/0097840X.1984.9934968.
Freeman EW, Rickels K, Huggins GR, Garcia CR, Polin J. Emotional distress patterns among women having first or repeat abortions. Obstet Gynecol. 1980 May;55(5):630-6.
Zolese G, Blacker CV. The psychological complications of therapeutic abortion. Br J Psychiatry. 1992 Jun;160:742-9. doi: 10.1192/bjp.160.6.742.
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Sharma V, Sommerdyk C, Sharma S. Post-abortion mania. Arch Womens Ment Health. 2013 Apr;16(2):167-9. doi: 10.1007/s00737-013-0328-0. Epub 2013 Feb 5.
Mahe V, Dumaine A. Oestrogen withdrawal associated psychoses. Acta Psychiatr Scand. 2001 Nov;104(5):323-31. doi: 10.1034/j.1600-0447.2001.00288.x.
Drower SJ, Nash ES. Therapeutic abortion on psychiatric grounds. Part I. A local study. S Afr Med J. 1978 Oct 7;54(15):604-8.
Kersting A, Kroker K, Steinhard J, Hoernig-Franz I, Wesselmann U, Luedorff K, Ohrmann P, Arolt V, Suslow T. Psychological impact on women after second and third trimester termination of pregnancy due to fetal anomalies versus women after preterm birth--a 14-month follow up study. Arch Womens Ment Health. 2009 Aug;12(4):193-201. doi: 10.1007/s00737-009-0063-8. Epub 2009 Mar 6.
Other Identifiers
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981/b
Identifier Type: -
Identifier Source: org_study_id
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