UvA-DARE (Digital Academic Repository)
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.
General rights
It is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an open content license (like Creative Commons).
Disclaimer/Complaints regulations
If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: https://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible.
Generall discussion and implications
forr future research
Generall discussion
Thiss thesis describes the diagnostic and therapeutic challenges in pregnant womenn with first-trimester bleeding. In case of a proven miscarriage we stud-iedd the natural course of expectant management, assessed the safety and effi-cacyy of expectant versus surgical management, the health-related quality of lifee during the three months after treatment, and the preferences of women forr one of the two treatment options. A cost effectiveness analysis was also partt of the study, but these data will be published separately at a later stage. Thee evidence presented in this thesis will be helpful in solving the controver-siess in the existing guidelines with regard to the diagnostic work-up and ther-apeuticc management of women with first-trimester bleeding.
Wee conclude that neither statistical prediction models based on signs and symp-toms,, nor clinical judgement can validly replace ultrasonographic assessment inn establishing a diagnosis in first-trimester bleeding. When a non-viable pregnancyy or an incomplete miscarriage is diagnosed, expectant and surgical managementt are both safe. In an RCT and in women managed according to theirr own preference we did not find differences in the complications and safetyy between expectant and surgical management. Expectant management wass successful within a week after inclusion in 38% of the women. The men-tall health of women randomised to expectant management showed better and earlierr improvement compared to women randomised to surgical evacuation. Mentall health scores were significantly better in women preferring than in womenn randomised to curettage. Women's treatment preference 12 weeks afterr treatment showed that women with an outspoken initial preference for onee particular management option held on to this preference regardless of the actuall treatment they had received. Women who accepted randomisation tendedd to prefer the treatment they had received.
Wee established the natural course of a miscarriage among women who were managedd expectantly. An increasing bleeding pattern was predictive of a quickerr spontaneous loss in women already bleeding at inclusion. Data from thee patients' diaries, reporting on bleeding patterns and pain during expec-tantt management, were used to construct a graphic representation of the spontaneouss course of miscarriages. As a result, a graphic representation of
CHAPTERCHAPTER 8
t h ee n a t u r a l course of a miscarriage is now for t h e first time available to inform w o m e nn a b o u t w h a t can b e e x p e c t e d .
T h ee large s a m p l e size, t h e unselected cohort, t h e availability of r a n d o m i s e d a n dd preference d a t a a n d t h e coverage of p r e f e r e n c e s , allows for the following conclusions: :
U l t r a s o n o g r a p h y is e s s e n t i a l for m a k i n g a diagnosis in p r e g n a n t women withh f i r s t - t r i m e s t e r b l e e d i n g .
In nonviable p r e g n a n c i e s or incomplete miscarriages e x p e c t a n t m a n a g e -m e n tt is a safe t r e a t -m e n t option.
An increasin g b l e e d i n g p a t t e r n is predictive for a relatively quick s p o n t a -neouss loss in f i r s t - t r i m e s t e r miscarriage.
M e n t a l h e a l t h is b e t t e r in women r a n d o m i s e d to e x p e c t a n t m a n a g e m e n t c o m p a r e dd to t h o s e r a n d o m i s e d to surgical e v a c u a t i o n .
A free t r e a t m e n t choice improves m e n t a l h e a l t h . T h e r e f o r e , women e x p r e s s i n gg a t r e a t m e n t preference should be allowed to follow t h e i r choice. W o m e n w i t h o u t a t r e a t m e n t preference should be e n c o u r a g e d to initially
followw e x p e c t a n t m a n a g e m e n t .
I n f o r m a t i o n on t h e o u t c o m e s of b o t h t r e a t m e n t options over time should be m a d ee a v a i l a b l e to p a t i e n t s to facilitate informed-shared decision-making. W ee studied t h e o u t c o m e of e x p e c t a n t m a n a g e m e n t and surgical e v a c u a t i o n in ann u n s e l e c t e d cohort of w o m e n with a diagnosis of non-viable p r e g n a n c y or i n c o m p l e t ee m i s c a r r i a g e , a case-mix as it a p p e a r s in real p r a c t i c e , i.e. without exclusionn of a n y specific t y p e of p a t i e n t s . By c o n d u c t i n g a r a n d o m i s e d trial w i t h i nn this g r o u p , a n d by concomitantly a c c o u n t i n g for t h e d a t a of t h e obser-v a t i o n a ll study of w o m e n who refused r a n d o m i s a t i o n , we aimed to i n c r e a s e t h ee g e n e r a l i s a b i l i t y of our findings to the n o r m a l p r a c t i c e s i t u a t i o n .1 Att t h e b e g i n n i n g of this project we e x p e c t e d t h a t a b o u t 5 0 % of eligible p a t i e n t ss would a c c e p t randomised t r e a t m e n t allocation. T o our s u r p r i s e , h o w e v e r ,, d e s p i t e t h e a b s e n c e of e v i d e n c e in favour of e i t h e r e x p e c t a n t or sur-gicall m a n a g e m e n t , 7 0 % of t h e women e x p r e s s e d a strong t r e a t m e n t prefer-e n c prefer-e .. This p r prefer-e f prefer-e r prefer-e n c prefer-e could not bprefer-e prefer-explainprefer-ed by prefer-e a r l i prefer-e r prefer-e x p prefer-e r i prefer-e n c prefer-e s of t h prefer-e s prefer-e w o m e nn with one of t h e t r e a t m e n t o p t i o n s . Possibly, p r e f e r e n c e s w e r e influ-e n c influ-e dd by c u l t u r a l b a c k g r o u n d or information givinflu-en by GPs or gynainflu-ecologists, b u tt we did not a n a l y s e t h i s . T h e women who refused r a n d o m i s a t i o n (n = 3 0 5 ) a n dd were m a n a g e d according their own choice were analysed in our observa-t i o n a ll p a r observa-t of observa-t h e s observa-t u d y . Our findings supporobserva-t observa-t h e views of earlier r e p o r observa-t s , observa-t h a observa-t R C T ss and n o n - r a n d o m i s e d studies can provide c o m p l e m e n t a r y e v i d e n c e .2 3 Inn our s t u d y , t h e p a t i e n t characteristics of the r a n d o m i s e d groups did not
dif-ferr from those of the women managed according to their own preference and findingss were identical with regard to efficacy, effect of intended treatment, andd safety. Although we are aware that combining the results of the RCT and thee observational study may raise criticism from a strictly methodological viewpoint,, we consider it unlikely that our findings would have been different withh larger numbers of randomised patients. Our specific design, including all presentingg patients with first-trimester problems, makes the results applica-blee to a normal practice situation. Arguably, our study is an example of valu-ablee use of observational methods.4
Almostt 50% of the women randomised to expectant management or choosing thiss treatment asked for a curettage (cross-over) after a variable period of time.. For most women it seemed unacceptable to wait longer than two weeks forr a spontaneous loss. It is most likely that the implementation of findings fromm our study in the management of future patients, may decrease cross-overr and encourage women opting for expectant management to accept a longerr period of waiting.
Recommendationss for research
Womenn from non-Western-European origin were relatively under-represented inn our RCT, the health-related quality of life study and the preference study, becausee these women were unable to read the English or Dutch questionnaires usedd for these parts of the study. However, we do not expect that the clinical resultss from the RCT (i.e. efficacy and safety) would have been different if wee had been able to also include this group of women. Health-related quality off life and treatment preference are possibly different in other cultures. Futuree research is needed to determine the influence of ethnicity on prefer-encess and health-related quality of life in miscarriages.
Untill recently, medical treatment did not seem to offer any advantage in com-parisonn with expectant or surgical management because of side effects, low effectivenesss (compared with curettage) and costs. Two recent studies com-paringg vaginal misoprostol versus expectant management and curettage respectively,, demonstrated an efficacy of 83.3% versus 48.3% (misoprostol versuss expectant) and 82.5% versus 100% (misoprostol versus curettage).5-6 Thee role of medical management of miscarriages needs further exploration. Determinantss of HRQL of women with a non-viable pregnancy need future at-tentionn in order to select women at risk of a worse HRQL after treatment for aa miscarriage. Further research into the long-term treatment effects on HRQLL is needed, including the influence of a next pregnancy thereupon. Thee new multi-disciplinary guideline on first-trimester bleeding which is to be
CHAPTERCHAPTER 8
developedd has to be implemented and evaluated. Also the need for the initia-tionn of Early Pregnancy Units, with easy access for women with first-trimester bleedingg in primary care, needs further exploration.
Recommendationss for practice
Basedd on our findings the following diagnostic and therapeutic recommenda-tionss can now be given.
Byy acknowledging the essential role of ultrasonography, this facility becomes aa basic diagnostic requirement. The availability of ultrasonography may vary widely,, depending on the health care system and geographical setting. In many countries,, pregnant women with first-trimester bleeding are initially cared forr by GPs and sometimes by midwives. For a safe and effective management off these women, transvaginal ultrasonography should be easily accessible to pregnantt women with first-trimester bleeding under primary care. In Primary Healthh Centers (U.K.), where ultrasonographic examinations were performed byy a trained physician or midwife, this diagnostic service has proven to be of use.77 In the Netherlands, however, ultrasonographic equipment and expertise aree virtually only available in Obstetric/Gynaecologic outpatient clinics and Radiologyy departments. The open access to these facilities for women under primaryy care, and the details and responsibilities for their further manage-mentt still need to be defined. An agreement on these issues must be reached betweenn the involved health care professionals and insurance companies, bothh on a local and national level.
Wee recommend expectant policy for at least a week after sonographical con-firmationn of the diagnosis in women with a non-viable pregnancy or incom-pletee miscarriage, unless the woman expresses an existing strong preference forr surgical evacuation.
Wee conclude that a multi-disciplinary guideline of GPs, midwives and gynae-cologistss on the management of miscarriages has to be developed for collabo-rationn in the field of miscarriage.
Basedd on the results of this thesis, the time is ripe for a new guideline which shouldd include the following acknowledgments:
Transvaginal ultrasonography is a basic requirement for establishing a diagnosiss in first-trimester bleeding. A correct diagnosis is essential in guid-ingg further management decisions.
When a non-viable pregnancy is diagnosed, expectant management during att least one week is feasible and useful without loss of safety.
In case of a strong preference for either expectant or surgical management womenn should be advised to follow their preference.
Women without a strong preference should be encouraged to follow expec-tantt management.
Gynaecologists should acknowledge the role of primary care in the expec-tantt management of miscarrying women. GPs/midwives should acknowl-edgee a strong preference for curettage in many women with a non-viable pregnancyy or incomplete miscarriage.
GPs/midwives and gynaecologists should provide detailed information to theirr patients about all aspects of expectant and surgical management in orderr to give patients the opportunity to make well-informed decisions.8"10 Forr a successful implementation of the guideline, the possible hindrances and practicall consequences need to be addressed in multi-disciplinary semi-nars.1 11 Apart from these educational efforts the willingness to change among thee health-care providers involved, is an essential prerequisite for a success-full implementation of the new guideline.12
References s
1.. Brewin CR, Bradley C. Patient preferences and randomised clinical trials. BMJ 1989;299:313-5. .
2.. Black N. Why we need observational studies to evaluate the effectiveness of health care.. BMJ 1996;312:1215-8.
3.. McKee M, Britton A, Black N, McPherson K, Sanderson C, Bain C. Methods in health servicess research. Interpreting the evidence: choosing between randomised and non-randomisedd studies. BMJ 1999;319:312-5.
4.. Mant D. Can randomised trials inform clinical decisions about individual patients? Lancett 1999;353:743-6.
5.. Demetroulis C, Saridogan E, Datakumar K, Naftalin AA. A prospective randomized con-troll trial comparing medical and surgical treatment for early pregnancy failure. Hum Reprodd 2001;16:365-9.
6.. Ngai SW, Chan YM, Tang OS, Ho PC. Vaginal misoprostol as medical treatment for firstt trimester spontaneous miscarriage. Hum Reprod 2001 ;16:1593-6.
7.. Everett CB, Preece E. Women with bleeding in the first 20 weeks of pregnancy: value off general practice ultrasound in detecting fetal heart movement. Br J Gen Pract 1996;46:7-9. .
8.. Charles C, Whelan T, Gafni A. What do we mean by partnership in making decisions aboutt treatment? BMJ 1999;319:780-2.
CHAPTERCHAPTER 8
10.. Little P, Everitt H, Williamson I, Warner G, Moore M, Gould C, Ferier K, Payne S. Preferencess of patients for patient centred approach to consultation in primary care: observationall study. BMJ 2001;322:1-7.
1 1 .. Wiebe E, Janssen P. Reducing surgery in management of spontaneous abortions. Familyy physicians can make a difference. Can Fam Physician 1999;45:2364-9. 12.. Mazmanian PE, Ratcliff Daffron S, Johnson RE, Davis DA, Kantrowitz MP. Information
aboutt barriers to planned change: a randomized controlled trial involving continuing medicall education lectures and commitment to change. Acad Med 1998;73:882-6.
