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Bleeding in the first trimester of pregnancy
Wieringa-de Waard, M.
Publication date
2002
Link to publication
Citation for published version (APA):
Wieringa-de Waard, M. (2002). Bleeding in the first trimester of pregnancy.
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Patientt preferences for expectant management
versuss surgical evacuation in
first-trimesterr miscarriage
datadata from a randomised study with
patientpatient preference arms
Margreett Wieringa-de Waard, Patrick J. E. Bindels, Jeroen Vos, Goukee J. Bonsel, Peep F.M. Stalmeier, Willem M. Ankum
Submittedd for publication
Abstract t
OBJECTIVESS To determine patient preferences for expectant or surgical management andd the influence of treatment assignment in randomised and non-randomised patients. DESIGNN Randomised controlled trial of expectant and surgical management; women whoo objected to being randomised were managed according to their own choice. SETTINGG Two Amsterdam hospitals.
PARTICIPANTSS Patients with non-viable pregnancies or incomplete miscarriages. MAINN OUTCOME MEASURES Preferences for expectant or surgical treatment. The strengthh of preference after treatment was measured by a trade-off technique, focus-singg on a variable period of vaginal bleeding and variable complication rates. RESULTSS One hundred and thirty six patients were analysed. Randomised women ulti-matelyy preferred the actually received treatment (expectant versus surgical manage-ment;; 76% versus 74% respectively). Women who were managed according to their ownn treatment choice, held on to their initial treatment preference (expectant versus surgicall management; 84% and 88%, respectively). Preferences after treatment were strong.. With a hypothetical 8% difference in complication rate between the two options,, 60% of the women still held on to their initial preference, while with a hypo-theticall 8-day difference in bleeding period, 74% of them did so.
CONCLUSIONSS In the management of first-trimester miscarriages women who refused randomisationn had a strong treatment preference, which should be taken into account in thee counselling process. Women who accepted randomisation held on to the actual treat-mentt they received; therefore, this group especially should be well-informed on all medi-call aspects of the two options in order to facilitate informed-shared decision-making.
Introduction n
Basedd on local custom and patient preference, surgical uterine evacuation or expectantt management are widely used in the management of miscarriages. Inn a randomised controlled trial no clinical differences were found between expectantt and surgical management in terms of safety and complications.1 In thee absence of clinical differences, patients' treatment preferences could thus playy a decisive role in the choice and acceptance of treatment.
Inn a classical randomised trial, however, the analysis of treatment preferences iss hampered because only those women are included who are willing to accept randomisedd treatment allocation. This limits the generalisability of the find-ingss from such a study to women who accept randomisation, while the results cannott be extrapolated to women who refuse randomisation because they want too follow their own explicit treatment choice.2 3 To overcome these limitations, wee studied treatment preferences in women randomised to expectant or sur-gicall treatment, and compared these with those of women who refused ran-domisationn and were subsequently managed according to their own choice.
Methods s
Patients Patients
Thee study was conducted between September 1998 and September 2000 in two Amsterdamm hospitals: the Academic Medical Center and the Onze Lieve Vrouwe Gasthuiss and approved by the medical ethics committees of both hospitals. Alll patients attending the outpatient clinic with first-trimester pregnancy problemss and an ultrasonographically confirmed diagnosis of a non-viable first-trimesterr pregnancy or an incomplete miscarriage were invited to partic-ipatee in this preference study. These women partially participated in a ran-domisedd controlled trial comparing expectant and surgical management. Womenn who refused randomisation were managed according to their own treatmentt choice.2 We excluded women from the preference study who were unablee to understand the Dutch questionnaires. The scheduling of visits and interventionss were similar in randomised and non-randomised patients. Surgicall uterine evacuation using suction curettage was performed within a weekk after inclusion in the study under local or general anaesthesia in day-timee surgery. General anaesthesia was used when cardio-pulmonary monitor-ingg was required or on patient request.
Expectantt management involved bi-weekly scheduled visits to our unit. Furtherr management in this group depended on clinical developments. Women whoo became impatient while being managed expectantly, and requested surgi-call evacuation as yet, were scheduled to undergo a curettage within a week.
DataData collection
Att inclusion the attending physician collected base line data on clinical signs andd symptoms, obstetric history and gestational age. Twelve weeks after inclusionn all women received a questionnaire inquiring about the method they wouldd opt for in case of a future miscarriage with an open question for record-ingg the reasons for that choice, about satisfaction with the received treatment andd demographic issues. By using a treatment preference technique the strengthh of preference was measured.4'5 First, all women were confronted withh the written descriptions they had received before treatment (appendix,). Afterr this information they were presented with a forced-choice between expectantt and surgical management in a baseline scenario, in which the hypotheticall bleeding period was set at 10 days and the complication rate at 10%% for the two treatment options. Patients were informed that differences inn bleeding period and complications for both options were not known at the timee of the study.
Afterr the women had indicated their preference, the strength of preference wass determined by eight trade-off questions. Each question consisted of two pre-definedd scenarios. Preferences were obtained separately for the two vari-abless 'days of bleeding' and 'complication rate'. If the preferred treatment wass expectant management, this treatment was made less desirable by increasingg the duration of bleeding (to 1, 2, 4 or 8 days more) or the compli-cationn rate (to 1, 2, 4 or 8% more) for expectant treatment. If the preferred treatmentt was surgical management, expectant management was made more desirablee by systematically lowering the bleeding period (to 1, 2, 4, or 8 days less)) or the complication rate (to 1, 2, 4 or 8% less) in the presented
scenarioss for expectant management. The level of the variables 'duration of bleeding'' and 'complication rate' which made the patient shift to the other treatmentt option, were registered.
StatisticalStatistical analysis
Womenn who returned the questionnaire (responders) and women who did not (non-responders)) were compared on patient characteristics and preference at inclusion.. Of the responders, we analysed patient characteristics according to allocationn by randomisation or by own treatment choice.
Inn order to study the influence of assignment and of actual treatment we com-paredd in the randomised groups assignment at inclusion and actual treatment withh the treatment women would opt for in case of a future miscarriage. In thee same way we compared in the preference groups the choice at inclusion andd actual treatment with treatment choice in future. To assess the strength off preference we determined the maximum number of bleeding days and the percentagee of complications women accepted before they shifted their treat-mentt preference. The shift points of women willing to be randomised were comparedd with those of women who had made their own treatment choice.
R e s u l t s s
GeneralGeneral characteristics
Off t h e 3 2 9 w o m e n who had b e e n t r e a t e d for a miscarriage by either surgical or e x p e c t a n tt m a n a g e m e n t , 89 were excluded b e c a u s e of insufficient D u t c h lan-guagee skills or b e c a u s e t h e y refused to p a r t i c i p a t e in this p r e f e r e n c e s t u d y . T h ee q u e s t i o n n a i r e was distributed t o t h e r e m a i n i n g 240 w o m e n , 136 ( 5 7 % ) of w h o mm c o m p l e t e d t h e questionnaire ( r e s p o n d e r s ) . T a b l e 6.1 shows t h a t t h e 1366 r e s p o n d e r s significantly more often originated from W e s t e r n - E u r o p e a n c o u n t r i e ss ( 8 2 % v e r s u s 4 2 % , p < 0 . 0 1 ) and w e r e older (33.4 v e r s u s 3 1 . 6 y e a r , pp = 0 . 0 2 ) t h a n w o m e n who did not r e s p o n d . No significant differences b e t w e e n r e s p o n d e r ss and n o n r e s p o n d e r s were found in the d i s t r i b u t i o n of initial t r e a t -m e n tt p r e f e r e n c e or a c c e p t a n c e of r a n d o -m i s a t i o n , or prior e x p e r i e n c e with a n yy of t h e m a n a g e m e n t o p t i o n s .
Tablee 6.1. Patient characteristics at inclusion of responders and non-responders.a
Responderss Non-responders Characteristicc (n = 136) (n = 104)
RandomisedRandomised at inclusion 55 (40.4) 28 (26.9) PreferredPreferred expectant management at
inclusioninclusion 32 (23.5) 32 (30.8) PreferredPreferred curettage at inclusion 49 (36.0) 44 (42.3)
Age-yr.,Age-yr., mean 33.4b 31.6
Parity Parity
00 72 (52.9) 50 (48.1)
11 50 (36.8) 27 (26.0) > 11 14 (10.3) 27 (26.0)
PriorPrior experience at baseline
Noo previous miscarriage 83 (61) 51 (49) Priorr curettage 31 (22.8) 36 (34.6) Priorr expectant management 14(10.3) 10 (9.6) Curettagee and expectant treatment 8 (5.9) 6 (5.8) Unknownn - 1 (1.0)
GestationalGestational age, mean, wk 10.1 10.5 NativeNative country
Western-Europee and USA 111 (81.6)b 45 (43.3)
Otherr and unknown 25 (9.4) 59 (56.7) aa
Number with percentage in parentheses. bb
Tablee 6.2. Patient characteristics at inclusion according to treatment preference.3 3 Characteristic c Expectant t <nn = 32) Curettage e <n=49) ) Noo dominant preference e (nn = 55) Age-yr,Age-yr, mean Parity Parity 33.2 2 33.4 4 aa
Number with percentage in parentheses. bb
Of four women unknown.
33.6 6
0 0 1 1 >1 1
PriorPrior experience at baseline
Noo previous miscarriage Priorr curettage
Priorr expectant management Curettagee and expectant
GestationalGestational age, mean NativeNative country
Western-Europee and USA Other r EducationEducation until-yrs << 18 >> 18b 17 7 11 1 4 4 20 0 7 7 4 4 1 1 (53.1) ) (34.4) ) (12.5) ) (62.5) ) (21.9) ) (12.5) ) (3.1) ) 10.2 2 26 6 6 6 11 1 20 0 (81.3) ) (18.7) ) (35.5) ) (64.5) ) 26 6 18 8 5 5 31 1 9 9 4 4 5 5 (53.1) ) (36.7) ) (10.2) ) (63.3) ) (18.4) ) (8.2) ) (10.2) ) 10.1 1 42 2 7 7 25 5 23 3 (85.7) ) (14.3) ) (52.1) ) (47.9) ) 29 9 21 1 5 5 32 2 15 5 6 6 2 2 43 3 12 2 24 4 29 9 (52.7) ) (38.2) ) (9.1) ) (58.2) ) (27.3) ) (10.9) ) (3.6) ) 10.0 0 (78.2) ) (21.8) ) (45.5) ) (54.7) )
Thee demographic characteristics of the 136 responders according to treatment preferencee at inclusion are summarised in Table 6.2. At inclusion, 32 of the womenn (24%) preferred expectant management, 49 (36%) preferred surgical evacuationn and 55 (40%) accepted randomised assignment. There were no significantt differences between the three groups in any of the demographic characteristics. .
RandomisedRandomised groups
Thee influences of assignment and actual treatment on patient preferences threee months after treatment are shown in Table 6.3. Of the 30 women ran-domisedd to expectant management, 16 (55%) women opted after 12 weeks for thee treatment conform their assignment at inclusion (left-hand side Table 6.3). Inn the group randomised to curettage 18/25 (72%) preferred after 12 weeks thee assigned treatment. Not all women were treated conform their assign-ment.. If we determined the influence of actual treatment on treatment choice
Tablee 6.3. Patient preferences 12 weeks after treatment, conform assignment {randomised or
choice)) and actually received treatment.
Randomisedd groups Randomisedd to expectantt (n = 30) Randomisedd to curettagee (n = 25) Preferencee groups Preferredd expectant (nn = 32) Preferredd curettage (n=49) ) n n 14 4 16 6 22 2 3 3 15 5 17 7 45 5 4 4 Received d treatment t Expectant t Curettage e Curettage e Expectant t Expectant t Curettage e Curettage e Expectant t Preferences s conform m assignment t 10 0 6 6 18 8 0 0 14 4 13 3 41 1 2 2 Preferences s not not conform m assignment t 4 4 10 0 4 4 3 3 1 1 4 4 4 4 2 2 Preferences s conform m received d treatment t 10 0 10 0 18 8 3 3 14 4 4 4 41 1 2 2 Preferences s nor r conform m received d treatment t 4 4 6 6 4 4 0 0 1 1 13 3 4 4 2 2
afterr 12 weeks, we found that 1 7 of the 55 randomised women received expec-tantt management and of this group 13/17 (76%) opted for this treatment. Of thee 55 randomised women 38 women underwent curettage and 28/38 (74%) wouldd choose this actual received treatment again.
AA quarter of the randomised women (14/55) opted for the not-received treatment inn case of a future miscarriage. Four women shifted from expectant management too curettage; two because of a negative experience with expectant management (bleeding,, pain) and two because of the uncertainties of expectant management. Tenn women shifted from curettage to expectant management, one because of a complicationn from curettage (i.e. Asherman's syndrome) and nine because of the perceivedd natural treatment characteristics of expectant management.
PreferencePreference groups
Inn the group that preferred expectant management we found that 27/32 (84%) wouldd again choose this treatment, despite the fact that only 15 (47%) of thesee women actually experienced a spontaneous loss. In the group that pre-ferredd curettage, a high number also held on their initial choice (43/49, 88%).. Agreement between preference after 12 weeks and received treatment wass 16/19 (84%) in women receiving expectant management and 45/62 (73%)) in women receiving curettage.
Off the 81 women of the preference groups, only 11 (14%) would choose the alternativee of the initial treatment option in the future. Six women would opt
c c S S <D D U> U> CO O c c ra ra E E 3 3 <u u »*— — o o a. . alll cases -- - Q randomised —— A - — preference #" " f f / / / / <vv > / / / /
Complicationss in case of expectant management
Figuree 6 . 1 . Patient preferences for surgical management according to differences in
complicationn rate between expectant and surgical management.
c c a> > E E o o O) ) ra ra c c ra ra E E ai i c c tt I <D D 'S S a a 7 0 %%
-Bleedingg period in case of expectant management
Figuree 6.2. Patient preferences for surgical management according to differences in
forr expectant management based on its more natural treatment characteris-tics.. Five women would opt for surgical treatment, one because of a negative experiencee (heavy bleeding) during expectant management, the others becausee of a positive curettage experience (performed on their request after ann initial expectant period).
Trade-off Trade-off
Figuree 6.1 shows the cumulative percentage of patients preferring surgical evacuationn related to its hypothetical complication rate. At the point of iden-ticall levels (equivalence point), i.e. 10% complications for both treatment options,, 41.5% of the women preferred expectant management while 58.5% preferredd surgical evacuation. By increasing the complication rate of expec-tantt management, an increasing number of women shifted to surgical evacua-tion.. At the point where the difference in complication rate reached 8%, the percentagee of women preferring expectant management had decreased from 41.5%% to 25%. By decreasing the complication rate of expectant manage-ment,, the percentage of women preferring curettage declined from 58% to 35%% in case of a difference in complication rate of 8%.
Figuree 6.2 shows the preference shift in relation to the period of vaginal bleeding. Byy prolonging the bleeding period in expectant management in comparison withh curettage by 8 days, the percentage of women preferring expectant man-agementt fell from 41.5% to 30%. If the period of vaginal bleeding were to last upp to 8 days shorter in expectant management, 43% of the 58.5% of women preferringg curettage would still hold on this preference.
Aboutt 60% of the women held on to their preference even in case of a difference inn complication rate of 8%; this was similar among women preferring expectant managementt and those preferring curettage. Also, about 73% of the women in bothh groups held on to their initial preference in case of a difference in bleed-ingg period of up to 8 days between the two options. Randomised women shifted earlierr to the alternative treatment in case of differences in complication rate thann women in the preference groups (Figure 6.1). We did not find these differ-encess by increasing the bleeding period of expectant management (Figure 6.2).
Conclusions s
Wee believe the study design used in this paper to offer the best approach cur-rentlyy available to correct for the limitations of a randomised trial when study-ingg patients treatment preferences. Earlier, Henshaw explored this type of design.33 Our findings underline the importance of taking into account the resultss of all eligible patients for optimising the generalisability of the results. Inn women with a miscarriage who consented to be randomised to either expec-tantt management or surgical evacuation, we found that the majority of wom-enn (76% and 74%, respectively) would opt for the recently received
mentt again. In women who refused randomisation and made their own treat-mentt choice for either expectant or surgical management, preferences remained unchangedd at a high level; respectively 84% and 88% of the women held on to theirr initial preference, independent of the actually received treatment.
Byy presenting a forced-choice twelve weeks after treatment we found that 41.5% off the women preferred expectant management and 58.5% preferred surgical evacuation.. The trade-off technique showed that these preferences were quite strongg 12 weeks after treatment. Women were more likely to shift to the non-preferredd treatment in case of a difference in complications between the two optionss (maximum 40% shift) than in case of a difference in the duration of vaginall bleeding (maximum 26% shift). Women in the preference groups held onn to their preference after treatment more strongly than women in the ran-domisedd groups.
Womenn with first-trimester bleeding and a viable pregnancy (n=77) were also askedd to fill out the preference questionnaire (data not shown). Of these women,, whose baseline characteristics were similar to the patients described inn this paper, 38% preferred expectant management and 62% surgical evacu-ation,, which is very similar to preferences of women with a non-viable preg-nancyy given above. Other studies reported differences of preferences between patientss and healthy women.6,7 Molnar assessed preferences under healthy, non-pregnantt women. Of these women, who were provided with similar infor-mationn on treatment options as used in our study, 75% indicated to opt for expectantt management.8 This important difference with our study might indicatee that non-pregnant women cannot be used as a reliable control group, becausee they are not at risk for a miscarriage.
Althoughh the number of included women is relatively small, our study con-firmss the results from other reports that participation in decision-making and managementt according to patients' own preferences results in a higher accep-tancee of treatment.3
Wee included only women who were able to read the Dutch questionnaire. Pos-sibly,, preferences of not Western-European women with different cultural backgroundd may differ from our findings.
Wee did not determine the reason for accepting or refusing randomisation. Al-thoughh a weak or absent preference could be the reason for women to accept randomisation,, it is also possible that other aspects, e.g. susceptibility to the argumentss of the researcher, may have been of influence on the decision to participate.. Llewellyn-Thomas reported that refusers of randomisation expres-sedd an aversion to the process of randomisation and a desire for more partici-pationn in management decisions.9 In our study only 30% of the eligible women acceptedd randomisation and we did find differences in preferences between randomisedd and non-randomised women.
Wee conclude that both expectant and surgical treatment are highly accept-ablee in women with a miscarriage. Most women with an outspoken preference
forr one particular management option hold on to their preference regardless off the treatment they have received. Women who accept randomisation tend too prefer the treatment they have received when asked later. Especially in thee latter group information on all medical aspects of both treatment options iss of importance in order to facilitate informed-shared decision-making.
References s
1.. Nielsen S, Hahlin M. Expectant management of first-trimester spontaneous abortion. Lancett 1995;345:84-86.
2.. Brewin CR, Bradley C. Patient preferences and randomised clinical trials. BMJ 1989; 299:313-5. .
3.. Henshaw RC, Naji SA, Russell IT, Templeton AA. Comparison of medical abortion with surgicall vacuum aspiration: women's preferences and acceptability of treatment. BMJ 1993;307:714-7. .
4.. Nieuwkerk PT, Hajenius PJ, Van der Veen F, Ankum WM, Wijker W, Bossuyt PM. Systemicc methotrexate therapy versus laparoscopic salpingostomy in tubal pregnancy. Partt II. Patient preferences for systemic methotrexate. Fertil Steril 1998;70:518-22. 5.. Palda VA, Llewellyn-Thomas HA, Mackenzie RG, Pritchard KJ, Naylor CD. Breast
can-cerr patients' attitudes about rationing postlumpectomy radiation therapy: applicability off trade-off methods to policy-making. J Clin Oncol 1997;15:3192-3200.
6.. O'Connor AM. Effects of framing and level of probability on patients' preferences for cancerr chemotherapy. J Clin Epidemiol 1989;42:119-26.
7.. Rosen AS. Acceptability of abortion methods. Baillieres Clinical Obstetrics & Gynaecologyy 1990;4:375-90.
8.. Molnar AM, Oliver LM, Geyman JP. Patient preferences for management of first-trimesterr incomplete spontaneous abortion. J Am Board Fam Pract 2000;13:333-7. 9.. Llewellyn-Thomas HA, McGreal MJ, Thiel EC, et al. Patients' willingness to enter
clin-icall trials: measuring the association with perceived benefit and preference for deci-sionn participation. Soc Sci Med 1991 ;32:35-42.
Appendix x
Expectantt management
Afterr a variable period of time you will experience vaginal bleeding, or the bleedingg which is already present will intensify. Usually the amount of blood losss does not exceed that of a normal period. During the expulsion of the fetus youu may suffer some pain due to uterine contractions. This pain is compara-blee with menstrual pain and may intensify for a couple of hours while the fetuss is being completely expelled: the miscarriage. You will then lose some tissue,, whereupon the bleeding and cramps stop almost immediately. You will nott have to go to a hospital.
Itt is uncertain for how long the blood loss will continue. It usually takes a couplee of days, very rarely a couple of weeks, for the spontaneous loss to occur.. If the blood loss should become excessive you will still have to undergo curettage. .
Curettage e
Curettagee is a minor surgical procedure during which the pregnancy is aspi-ratedd from the uterus by inserting a small tube in the vagina and cervix. This proceduree can be performed under either general or local anaesthesia. In the latterr case the procedure takes place as outpatients' treatment. You will be admittedd in the morning and, if there are no complications, you can go home inn the afternoon, a few hours after the procedure. For a few days you will still experiencee some blood loss.
Everyy surgical procedure carries the risk of complications. On rare occasions thee pregnancy turns out not to have been removed completely. In that case youu will have to undergo another curettage.
