prevalence and risk factors
Diarienummer : RFR-28441
Ny ansökan RFR oktober 2008
Ansökan påbörjad av : Agneta Skoog Svanberg, 2008-09-18
Yrkestitel vid ansökningstillfället : Universitetslektor
Arbetsplats vid ansökningstillfället : Inst för kvinnor och barns hälsa, Uppsala universitet
Senast ändrad/åtgärdad av : Marianne Omne-Pontén, 2010-12-09
Ansökan inkommen till : Regionala forskningsrådet i Uppsala- och Örebroregionen
- Sökanden: Agneta Skoog Svanberg
Barnmorska, Inst för kvinnor barns hälsa, Uppsala universitet samt Divisionen kvinnor och barn, Akademiska sjukh
A Övergripande projektinformation
Kön på huvudsökanden
kvinnaSammanfattning
The numbers of legal abortions are increasing in Sweden, and approximately every fourth pregnancy ends in an induced abortion. Even though abortion can be considered a development crisis, most women cope well with having an abortion. In a setting with a liberal abortion law since decades, with every second women having at least one abortion during her life-time, and where two-thirds of the abortions are done before the ninth pregnancy week, few women consider induced abortion as a stigma. However, there is an increasing awareness that the abortion as such may deteriorate a pre-existing depressive and/or anxiety disorder or trigger the onset of a new depressive episode. For a smaller fraction of women, the induced abortion represents a significant life-trauma which in turn may predispose them to develop a post-traumatic stress disorder with life-long consequences. These long-term consequences may have repercussions for their future reproductive experiences and also increases their vulnerability to co-morbid depressive and anxiety disorders. In order to improve the care of all women undergoing induced abortion the present study will to assess the prevalence of post-traumatic stress disorder (PTSD), PTSD symptoms, depressive symptoms and anxiety symptoms following induced abortion and evaluate risk factors for development of PTSD or deterioration of mood and anxiety following induced abortion. The study will comprise 1500 women seeking care for legal abortion at three different sites in Sweden.Medarbetare/Medsökande
- Ingrid Östlund
Läkare, Kvinnokliniken Universitetssjukhuset Örebro
- Länstillhörighet:
- T
- Projektledning:
- Participated in planning the project. Responsible for the study at the abort unit at Örebro University hospital
- Patientrekrytering:
- Plan to start recruiting patients,abort seeking women, in January 2009
- Arbetsenhet:
- Örebro University hospital
Handledare
- Inger Sundström Poromaa
Läkare, Kvinnokliniken, Akademiska sjukhuset
Utbildning
doktorandutbildningÖversikt av projektorganisation
| namn | handledar-insats | projekt-ledning | datain-samling | data-analys | medför-fattare | länstill-hörighet | |
|---|---|---|---|---|---|---|---|
| medarb 1 | Inger Sundström Poromaa | ja | ja | ja | ja | ja | C |
| medarb 2 | Ingrid Östlund | nej | ja | ja | ja | nej | T |
| medarb 3 | nej | ja | ja | ja | ja | ||
| medarb 4 | nej | ja | ja | ja | ja | ||
| medarb 5 | |||||||
| medarb 6 |
Projektstart
2009-02-01Beräknat projektslut
2010-02-01B Projektbeskrivning
Bakgrund
Even though abortion can be considered a development crisis, most women cope well with having an abortion. In a setting with a liberal abortion law since decades, with every second women having at least one abortion during her life-time, and where two-thirds of the abortions are done before the ninth pregnancy week, few women consider induced abortion as a stigma. This is further substantiated by findings from a long-term follow-up study of 58 women. One year after the abortion most of statements given by the women were positive such as maturity, responsibility, relief and release, while fewer were concerned with grief, guilt and emptiness, regrets or doubts, anger and powerlessness. Only two women reported that they still were suffering from a crisis (1).Currently two abortion methods are available for women who have their abortion before the ninth gestational week. Medical and surgical abortion are both evidence-based methods, with comparable medical advantages and disadvantages (2). In Sweden, medical abortion presently comprise 50-80% of abortions before the ninth pregnancy week, and women are offered an informed consent of the procedure. Most frequently reported reasons for choosing the medical method is to avoid certain aspects of the operative process, particularly the anesthesia (61%), and because the method appears simpler and more natural (32%). Those women who choose the surgical procedure stated reasons such as avoiding the awareness and involvement in the abortion process (49%) and they were also concerned about the pain during the procedure (16%) or emotional impact of the medical termination (3). A Cochrane review (Say 2007) concluded that a majority of women would prefer the same method in case of a repeat abortion. However, of these women fewer would have a medical abortion a second time, 63 – 74 % than those who would choose a surgical abortion the next time, 79 - 92% (4-6).
Currently, there is no evidence that mental sequels following an abortion are associated with the abortion method that has been used.
Population-based studies indicate that exposure to traumatic events may be common, with exposure rates ranging between 30 and 69% (7). It has been suggested that that every fourth subject who experience a trauma will develop a post-traumatic stress disorder (PTSD). Furthermore, women are more likely to develop PTSD than men following the exposure of a trauma (7).
The diagnostic criteria of PTSD include a) re-experiencing symptoms in nightmares, flashbacks or intrusive thoughts, b) avoidance symptoms such as avoiding thoughts or places associated with the trauma; c) emotional numbings symptoms such as feeling unable to have sad or loving feelings, d) hyper arousal symptom such as sleep and concentrations difficulties, or hyper vigilance (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition).
Lifetime population prevalence rates of PTSD in Sweden and the U.S. indicate that 7.4 -10.4% of women and 3.6 - 5.0% of men are affected, while an Australian national survey found a 12 month prevalence rate of 1.3% but no gender-related difference(8,9). Co-morbidity with major depression, generalized anxiety disorder, panic disorder, social phobia and substance abuse is common (10).
Individual vulnerability and baseline levels of depression, anxiety and avoidant symptoms predispose for PTSD after an accidental burn. The life-threat at a burn event predicted intrusive and arousal symptoms, while coping by self-control predicted less intrusive symptoms. Neurotic personality is also a risk factor for post-traumatic stress disorder (11). Exposure to violence might also predispose to development of PTSD. In a Swedish population study 7% of young women report exposure to severe sexual abuse during the last year concomitant with current suffering.
Less is known about the relationship between reproductive events and PTSD, in particular when reproductive events are perceived as traumatic. Traumatic reproductive events may include a prolonged and painful delivery, an emergency caesarean section, or an induced abortion. Following childbirth PTSD is prevalent in 1.5 - 3% of women. Intolerable pain or unanticipated complications as emergency caesarean section or instrumental delivery, dominate the delivery experience in these women PTSD. Among primipara women who had a normal vaginal delivery four out of eight with PTSD symptoms had a history of psychiatric or psychological counselling (12).
Although risk factors for PTSD are more prevalent among women having an abortion than among women having a term pregnancy, there are no indications of a higher prevalence of PTSD in women having an abortion. Possible risk factors for PTSD in women who have an induced abortion may include exposure to violence, adolescence, life-time risk for suicide. Data regarding abortion and PTSD are, however, few and yield imprecise estimates. One study from the U.S. reported a prevalence rate of 1 % (6 cases among 418 women), while other studies from the U.S. (n = 217) and Russia (n = 331) reported PTSD to be prevalent in 14.3% and 0.9% of women, respectively. In the two latter studies, PTSD symptoms such as increased arousal, re-experiencing of trauma and avoidance symptoms were prevalent in 65% and 13% of women, respectively.
From the U.K. and the U.S. post-abortion depression rates of 9-20% have been reported. There are no comparable studies from Sweden on post-abortion depression, and furthermore, risk factors for development or worsening of depression have not been fully elucidated. Preferably, by identifying women at risk for PTSD and depression already at their initial visit to the clinic, targeted efforts to aid these women through the abortion process would reduce the risk of sustained mental health hazards following the abortion.
Syfte/frågeställning/hypotes
The objectives of the proposed study is1) to assess the prevalence of post-traumatic stress disorder (PTSD) for women with unwanted pregnancies,
2) to assess prevalence of PTSD and PTSD symptoms such as intrusive thoughts, avoidance behavior and arousal following induced abortion,
3) to assess risk factors for detoriation or development of PTSD following induced abortion, such as personality traits, age, parity, pre-existing depression and/or anxiety and abortion method (medical and surgical abortion),
4) to assess risk factors of deterioration of depressive symptoms and anxiety symptoms following induced abortion.
Design och urval (ex. urval, gruppindelning)
The study is a cross-sectional multi-center hospital-based study.Setting: The Outpatient Clinics of Departments of Obstetrics and Gynecology at 1) Uppsala Akademiska hospital 2) Södersjukhuset 3) Örebro University Hospital 4) Umeå University Hospital had the year 2007 following numbers of induced abortion (before 12th pregnancy week): 1) 965; 2) 2 328; 3) 551; 4) 753 (in total 4597). In the four hospitals the proportion of medical abortion varied between 44-80%, and the proportion of home abortions varied between 1-20%.
Baseline assessment: All women asking for abortion with a gestational length less than 12th pregnancy weeks will be approached for participation in the study. At registration for the first abortion visit at the outpatient clinics, patients will be informed about the study. Subjects who accept to participate will be given a patient information (invitation letter) together with the questionnaires. Women will be asked to fill out the questionnaires in the waiting room and to hand in the questionnaires (in a locked mail-box) before leaving the clinic.
Exclusion criteria for the study are (1) inability to read and understand the questionnaire because of language difficulties, (2) not providing informed consent.
Follow-up postal questionnaires, with two reminders, will be sent to those who participated in the baseline assessment. The follow-up questionnaires will be sent out to women three months following the first abortion visit. An additional questionnaire will be sent out after six months, as symptoms may remit spontaneously.
The data collection will start in February 2009 and it is estimated that the inclusion period will last approximately during 2009, or until 1 500 subjects have been recruited.
Power: to estimate a PTSD prevalence of 1%, with 95% confidence limits, out of all induced abortions in Sweden a sample of 1 500 women will be needed. With a response rate of 70% 2 150 women will be asked to participate. By assuming a prevalence of 15% of PTSD symptoms (9) the sample of 1 500 and a power of 80% it will be possible to detect a risk increase of hypothesised risk factors as primigravidity (40%), depressive symptoms pre-abortion (70%) and abortion method (50%).
Metod och datainsamling/ -bearbetning
Study instruments
Baseline:
a) Personality: The Swedish universities Scales of Personality (SSP) contains 91 items divided into 13 scales with 7 items: somatic trait anxiety, psychic trait anxiety, stress susceptibility, lack of assertiveness, detachment, embitterment, trait irritability, mistrust, impulsiveness, adventure seeking, social desirability, verbal trait aggression, physical trait aggression (14).
b) Hospital Anxiety and Depression scale (HAD) messures anxiety and depression and contains 14 items devided in 2 scales: anxiety 7 items and depression 7 items. The instrument is translated and validated for Swedish cirkumstances (13).
c) Screen Questionnaire - Post traumatic Stress Disorder (SQ-PTSD ) is an instrument used for investigation and diagnostic purposes and are based on the DSM IV criteria (9).
d) Sociodemographic data will be collected by use of a brief questionnaire. Age, parity, relationship, education, ethnicity, occupation, contraceptive use, number of previous abortions will be asked for.
e) A blood sample (whole blood) is collected for analyses of polymorphisms of genes known to be associated with psychiatric vulnerability; CRHR1, 5-HTT (long vs short allele), MAO-A, TPH2, and estradiol receptor beta (samples will be collected only in Uppsala and Umeå).
Patient record
a) Waiting-time between booking and abortion, abortion method (surgical or medical), place of abortion (home or hospital), analgesia during surgical abortion, pain alleviation during medical abortion, VAS-scoring of pain if available.
b) Outcome, revisits, psychosocial support, complications as re-abortion, haemorrhage and infection.
Follow-up 3 months:
a) HAD (25)
b) SQ-PTSD (3)
c) Question from KUPP (Kvalitet Ur Patientens Perspektiv) questionnaire about the care when the abortion was performed
Follow-up 6 months:
a) HAD (25)
b) SQ-PTSD (3)
Analysis
Data from the questionnaires and supplementary information from clinical records willl be entered in the SPSS software. Prevalences of PTSD and PSTD-symptoms will be presented. Prevalence estimate of the 95% confidence interval will be calcualted using Poisson approximation. Logistic regression calculating odds ratios and 95% CI univariate and multivariate, will be applied to analyze risk factors associated with development of post-abortion PTSD, PTSD-related symptoms and depressive symptoms. A hypothetical "Path Model" to assess different weights of factors associated with the development post-abortion PTSD symptoms and depressive symptoms will be developed.
Studiens genomförande
The co-workers (project team) have discussed and participated in developing the project plan. The project team have at each participating clinic identified a local administrative person responsible for the study procedure (recruitment, baseline data, informed consent, blood sample). The study will be conducted in close co-operation with abortion clinics in each site, doctors and nurses will be informed in regular meetings arranged by the project leader (Agneta Skoog Svanberg). Confidentiality will be assured and code lists with names and numbers will be kept locked in and will only be accessible by the researchers. The project leader will together with a project coordinater in Uppsala be responsible for sending out and receiving follow-up questionnaires at 3 and 6 months.Forskningsetiska överväganden
Women who will undergo an induced abortion are in a vulnerable situation. Questions may evoke ambivalent feelings among respondents and it is important that participation is on a voluntary basis. However, abort-seeking women as a group may benefit from the results of the study. We carefully consider the formulation of the invitation letters for the study and ask women to actively sign up for participation in the study in order to avoid pressure from health care staff or research team.Etisk prövning
Ansökan till etikprövningsnämnden är gjord eller planeras- Datum för beslut från etikprövningsnämnden
- 2005-02-23
- Diarienummer på beslut från etikprövningsnämnden
- dnr M29-05
- Godkännande från etikprövningsnämnd krävs efter beslut för utbetalning av medel
Etisk prövning behövs ej
Referenser
1. Kero A, Hogberg U, Lalos A. Wellbeing and mental growth-long-term effects of legal abortion. Soc Sci Med 2004;58(12):2559-2569.2. SFOG. Inducerad abort.54: Arbets- och referensgrupp för familjeplanering
2006.
3. Slade P, Heke S, Fletcher J, Stewart P. A comparison of medical and surgical termination of pregnancy: choice, emotional impact and satisfaction with care. Br J Obstet Gynaecol 1998;105(12):1288-1295.
4. Creinin MD. Randomized comparison of efficacy, acceptability and cost of medical versus surgical abortion. Contraception 2000;62(3):117-124.
5. Ashok PW, Kidd A, Flett GM et al. A randomized comparison of medical abortion and surgical vacuum aspiration at 10-13 weeks gestation. Hum Reprod 2002;17(1):92-98.
6. Henshaw RC, Naji SA, Russell IT, Templeton AA. Comparison of medical abortion with surgical vacuum aspiration: women's preferences and acceptability of treatment. Bmj 1993;307(6906):714-717.
7. Meltzer-Brody S, Hartmann K, Miller WC et al. A brief screening instrument to detect posttraumatic stress disorder in outpatient gynecology. Obstet Gynecol 2004;104(4):770-776.
8.Creamer M, Burgess P, McFarlane AC. Post-traumatic stress disorder: findings from the Australian National Survey of Mental Health and Well-being. Psychol Med 2001;31(7):1237-1247.
9. Frans O, Rimmo PA, Aberg L, Fredrikson M. Trauma exposure and post-traumatic stress disorder in the general population. Acta Psychiatr Scand 2005;111(4):291-299.
10.Breslau N, Davis GC, Peterson EL, Schultz L. Psychiatric sequelae of posttraumatic stress disorder in women. Arch Gen Psychiatry 1997;54(1):81-87.
11. Chung MC, Easthope Y, Farmer S et al. Psychological sequelae: post-traumatic stress reactions and personality factors among community residents as secondary victims. Scand J Caring Sci 2003;17(3):265-270.
12. Soderquist J, Wijma K, Wijma B. Traumatic stress after childbirth: the role of obstetric variables. J Psychosom Obstet Gynaecol 2002;23(1):31-39.
13. Zigmond, AS., Snaith, RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand, 1983. 67:361-370
14. Gustavsson JP, Bergman H, Edman G, Ekselius L, von Knorring L, Linder J. Swedish universities Scale of Personality (SSP), construction, internal consistency and normative data. Acta Psyciatr Scand 2000:102:217-225.
C Bilagor
Bilagor
ASS RFR.pdf- Godkännande från EPN
Filstorlek: 61 kB
D Sammanfattande kostnadsbeskrivning / budget för projektet
Total budget
| År 1 | År 2 | År 3 | |
|---|---|---|---|
| Kalenderår som avses | 2009 | 2010 | 2011 |
| Lönemedel - Sökande | |||
| Lönemedel - Medarbetare | 366000 | 366000 | 366000 |
| Lönemedel - Assisterande personal | 302000 | 302000 | 96000 |
| Konsulter | |||
| Medicinsk service | 70000 | 70000 | |
| Utrustning | |||
| Övrigt | 120000 | 25000 | |
| Summa |
Total summa
2 125 000Andra bidragsgivare
Andra bidragsgivare
| Bidragsgivare: Uppsala universitet, medicinska fakulteten , Bidragstagare: Agneta Skoog Svanberg , Bidragsperiod:2008 | ||||||
| Bidrag avsett för | Diarienr | Datum | Äskade medel | Beslutsdatum | Beviljade medel | Status på ansökan |
|---|---|---|---|---|---|---|
| Vårdforskningsmedel | 2008-04-15 | 1 200 000 | 2008-06-15 | 100 000 | Beslutad och antagen | |
| Summa kronor | 1 200 000 | 100 000 | ||||
Äskade medel från Regionala forskningsrådet i Uppsala- och Örebroregionen
Personal
Ph D student 50%: 183000kr incl LKPMain project coordinatorer 4 clinics x 5%: 54000kr incl LKP
Project coordinator 40-50%: 196000kr incl LKP
Medicinsk service
Laboratory analysis; Reagens for genotypningUtrustning
Printing questionnairesE Projektledarens egen bedömning
Bedömning i vad mån projektet är patientnära
Although most women cope well with having an abortion, there is an increasing awareness that the abortion as such may deteriorate a pre-existing depressive and/or anxiety disorder or trigger the onset of a depressive episode. For a smaller fraction of women, the induced abortion represents a significant life-trauma which in turn may predispose them to develop a post-traumatic stress disorder with life-long consequences. These long-term consequences may have repercussions for their future reproductive experiences and also increases their vulnerability to co-morbid depressive and anxiety disorders. Evidence based knowledge of PTSD after induced abortion is limited.Bedömning av projektets kliniska betydelse
By elucidating treatment-related risk factors for development of PTSD, PTSD symptoms and depressive symptoms we will gain valuable information on how to improve the care of all women undergoing induced abortion.Bedömning av det regionala samarbetet och dess betydelse
The project combine medical and psychological competens with caring science, and will generate improved knowledge so the region will guarantee the abort seeking women the very best care and support in the future.There will be regular meetings with staff (doctors, midwives, administrative staff) involved in the study focusing on the study procedures together with reflections of the abortion care.
Publicering
The project group and the staff involved will implement the results in the clinical work in the region. The results will be published in international scientific journals. The results will also be presented in abstracts/posters and oral presentations in Sweden as well in international scientific congresses.
Bedömning ansökan
Granskningssammanställning
| Bedömningar | [0.00] | [0.25] | [0.50] | [0.75] | [1.00] | [1.25] | [1.50] | [1.75] | [2.00] | [2.25] | [2.50] | [2.75] | [3.00] | [3.25] | [3.50] | [3.75] | [4.00] | [4.25] | [4.50] | [4.75] | [5.00] |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Del 1. Patientnära klinisk forskning | 2 | 2 | |||||||||||||||||||
| Del 2A. Reg samv - Patientrekrytering, 0.25 poäng per landsting | 3 | 1 | |||||||||||||||||||
| Del 2A. Reg samv - Forskare / Handledare, 0.5 poäng per forskare / handledare | 1 | 2 | 1 | ||||||||||||||||||
| Del 2A. Reg samv - Doktorand, 0.5 poäng per doktorand | 2 | 2 | |||||||||||||||||||
| Del 2A. Reg samv - Kliniker, 0.25 poäng per medverkande klinik | 2 | 2 | |||||||||||||||||||
| Del 2B. Reg samv - 3-4 parter ger 0.5, >= 5 parter ger 1.0 | 4 | ||||||||||||||||||||
| Del 2C. Reg samv - Granskarens värdering | 2 | 2 | |||||||||||||||||||
| Del 3A. Vet kvalitet - Frågeställning | 2 | 1 | 1 | ||||||||||||||||||
| Del 3B. Vet kvalitet - Metodik | 1 | 2 | 1 | ||||||||||||||||||
| Del 3C. Vet kvalitet - Kompetens / genomförbarhet | 3 | 1 | |||||||||||||||||||
| Summa | 8 | 9 | 3 | 3 | 3 | 1 | 4 | 5 | 4 |
Beslut ansökan
Beslutsdatum: 2008-12-04
| Kort beskrivning av respektive kostnad | Äskade medel | Beslut SEK | Beslutskommentar |
|---|---|---|---|
| Summa | |||
| Ph D student 50%: 183000kr including LKP Project coordinator at 4 clinics x 5%:54000 kr including LKP Main project coordinator 40-50% 196000kr including LKP Laboratory analysis: 42000kr Prints, questionnaires: 27000kr | 500 000 | 200 000 | |
| summa | 500 000 | 200 000 | |
