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.
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Generall introduction
Introduction n
Twoo out of every ten pregnant women experience an episode of vaginal bleeding duringg the first trimester. In 50% of these women the pregnancy is viable and thee bleeding will stop after a certain period of time without further conse-quences.. In the remaining 50% of women, however, the pregnancy is non-viable andd the bleeding period heralds a miscarriage.1 In most countries surgical evacuationn is the preferred treatment for miscarriages.2 Some observational studiess and one randomised trial have also described expectant management ass a realistic alternative to surgical evacuation.3"5
Thee guideline on imminent miscarriage of the Dutch College of General Prac-titionerss (first issued in 1989, revised in 1997) advises women in the Nether-landss to first await the natural course of the bleeding, and to withhold from furtherr diagnostic investigations, i.e. ultrasonography.6,7 After one week, if thee diagnosis is still unclear, these women are referred for an ultrasonograph-icc assessment. In case of a non-viable pregnancy, the guideline then propa-gatess expectant management. The restrictive use of ultrasonography is based onn the premise that in either case, whether the bleeding results from a viable orr a non-viable pregnancy, the ultrasonographic findings will have no thera-peuticc consequences whatsoever.
Thee first Dutch guideline was based on a study, initiated by the Dutch College off General practitioners in the late 1950s, which resulted in two theses pub-lishedd in 1964 and 1966.6>8,9 This study was performed in a primary care set-tingg and included more than 1500 women with a miscarriage. The diagnosis wass solely based on patient histories. Spontaneous expulsion of products of conceptionn was verified by the GPs' inspection of any lost tissue. In the ab-sencee of both a urinary pregnancy test and transvaginal ultrasonography, cur-rentlyy the gold standard for establishing the cause of first-trimester bleeding, considerablee diagnostic errors were probably made. Clearly, a guideline to be usedd today cannot validly be based on the evidence from this study.
Inn the revised version of the guideline, the results of a recently performed randomisedd controlled trial were incorporated.7 This hospital-based trial comparedd expectant management with surgical evacuation in women with ultrasonographicallyy confirmed miscarriages, and suggested the outcomes to bee similar.5 However, the duration of expectant management in that study wass restricted to only three days, while the majority of included women had ann incomplete miscarriage. Three days of follow-up cannot seriously be
CHAPTERCHAPTER 1
regardedd as 'true expectant therapy', neither from a practical nor from an em-piricall point of view. The over-representation of women with an incomplete miscarriage,, thus excluding the vast majority of women with a non-viable pregnancy,, also limits the generalisability of these findings from this study for every-dayy practice.
Inn contrast to the Dutch GP guideline, the Dutch Society of Obstetrics and Gynaecologyy advises a sonographic assessment in all women with first-trimesterr bleeding, enabling a distinction between viable and non-viable pregnancies.. In case of a non-viable pregnancy the advice is 'to prevent pro-longedd bleeding and infection'.10 Consequently, curettage is often the pre-ferredd treatment in these cases.
Bothh recommendations are neither evidence-based nor representative for cur-rentt practice. In fact, a recent study showed no adherence of GPs to the guide-linee in 56% of cases of threatened miscarriage.11
First-trimesterr bleeding, being a problem which affects two out of every ten pregnantt women, needs management based on scientific evidence. The com-binationn of unsatisfactory evidence from the literature, the high incidence of thiss clinical problem, and the conflicting recommendations with respect to its management,, were the reasons to start the study presented in this thesis.1 2
Thee aim of the present study
Thee aim of the study presented in this thesis is to answer the following questions: 11 . What is the value of patient's medical history and physical examination in
diagnosingg the underlying cause of first-trimester bleeding during pregnancy? 22 . Which treatment is preferable in the management of first-trimester
mis-carriage:: expectant management or surgical evacuation?
33 . Are there any differences in health-related quality of life between expec-tantt or surgical management in the treatment of miscarriages?
4 .. Which treatment do women prefer in first-trimester miscarriage? 55 . What is the natural course of a first-trimester miscarriage?
Terminology y
Wee have used the term miscarriage instead of spontaneous abortion.13 First-trimesterr miscarriage is defined as 'a miscarriage occurring before the gestational agee of 16 completed weeks following the first day of the last menstrual period'.
Studyy design
Wee performed an observational study (to answer questions 1 and 5) as well as ann intervention study (questions 2 to 4). In order to cover the whole range of womenn with first-trimester bleeding we not only enrolled women attending the outpatientt clinics or the emergency departments because of pregnancy com-plicationss in the first trimester, but we also asked general practitioners and midwivess to refer all consecutive women with first-trimester vaginal bleeding forr an ultrasound assessment. All GPs/midwives working in the health district coveredd by two Amsterdam hospitals, the Academic Medical Center and the Onzee Lieve Vrouwe Gasthuis, were asked to participate in the study during a speciallyy organised seminar about first-trimester bleeding during pregnancy. Thee GPs/midwives were visited by the researcher and received information aboutt the study. Ultimately 74 GPs and 8 midwives agreed to participate and includedd one or more patients in the study. During the consultations of eligi-blee patients, the participating GPs/midwives used structured questionnaires andd registered signs and symptoms and findings of gynaecological examina-tions.. Referral of eligible patients was facilitated by direct telephone access too the researchers. A special daily ultrasonographic facility was created, enablingg referral to our unit within two days. To inform the participating GPs/midwivess about our project, and to remind them to send in patients, a newsletterr was sent out every four months.
Thee flow of participants is presented in the Figure below. Between April 19988 and September 2000 we enrolled 1101 women in the study. For the observationall part of the study we registered signs, symptoms and the final diagnosiss of all women. Women with a confirmed diagnosis of a viable
preg-Transvaginal l sonography y (n=1101) ) Non-viablee pregnancy (n=419) )
"
Incompletee miscarriage (n=30) )L* *
Excludedd (n=652) -- viable pregnancy complete miscarriage -- other diagnosis Randomisation n (n=122) ) Inclusionn I (n=427)) ' I Preference e (n=305) ) Excludedd (n=22) -- immediate curettage necessary y —WW Expectant (n=64) —fcc Curettage (n=58) - WW Expectant (n= 126) ) - kk Curettage (n=179)CHAPTERCHAPTER 1
nancyy were referred back to their GP or midwife. These women received a ques-tionnairee at term to check the outcome of the index pregnancy. Women with aa complete miscarriage, an ectopic pregnancy, or a molar pregnancy, were managedd according to the hospital protocol.
Womenn with a non-viable pregnancy or an incomplete miscarriage were asked too participate in the intervention study. Consenting women took part in the randomisedd controlled trial comparing expectant and surgical management. Womenn who refused to be randomised were managed according to their own treatmentt choice, and were asked to participate in the observational study.
Outlinee of this thesis
CHAPTERR 2 gives an overview of the history of the management of
first-trimes-terr miscarriage.
CHAPTERR 3 analyses the diagnostic accuracy of the patient's medical history andd physical examination in predicting the underlying cause of the first-tri-mesterr vaginal bleeding. In addition, we analysed the accuracy of the GPs/mid-wivess in making a provisional diagnosis based on their clinical impression beforee referral (question 1).
CHAPTERR 4 AND 5 describe a randomised controlled trial comparing expectant managementt and surgical evacuation in terms of safety, complications and successs rates (chapter 4). Health-Related Quality of Life issues are analysed inn chapter 5. The outcomes of the trial are compared with those of women treatedd according to their own preference (question 2 and 3).
CHAPTERR 6 provides information on treatment preferences for surgical evac-uationn or expectant management in women with first-trimester bleeding or a non-viablee pregnancy (question 4).
CHAPTERR 7 describes the natural course of miscarriages (question 5).
CHAPTERR 8 discusses the results of the study. Implications for guidelines and forr future research are indicated.
CHAPTERR 9: Summary, samenvatting.
References s
1.. Everett C. Incidence and outcome of bleeding before the 20th week of pregnancy: prospectivee study from general practice. BMJ 1997;315:32-4.
2.. Hemminki E. Treatment of miscarriage: Current practice and rationale. Obstet Gynecoll 1998;91:247-253
3.. Ambulatory Sentinel Practice Network. Spontaneous abortion in primary care. J Am Boardd Fam Pract 1988;1:15-23.
4.. Nielsen S, Hahlin M. Expectant management of first-trimester spontaneous abortion. Lancett 1995;345:84-6.
5.. Wiebe E, Janssen P. Management of spontaneous abortion in family practices and hospitals.. Fam Med 1998;30:293-6.
6.. Flikweert S, Ligtenberg WJJ, Sips AJBI. NHG-Standaard dreigende miskraam (Dutch Societyy of General Practitioners. Practice guideline threatened miscarriage). Huisarts Wett 1989;32:138-43.
7.. Flikweert S, Meijer LJ, De Haan M, Wiersma Tj. NHG-Standaard Miskraam, eerste herzieningg (Dutch Society of General Practitioners. Revised practice guideline mis-carriage).. Huisarts Wet 1997;40:661-70.
8.. Ligtenberg WJJ. Abortus in de huisartsenpraktijk. Dissertation, Leiden: Stenfort Kroese,, 1966.
9.. Roorda PA. De behandeling van de dreigende abortus. Dissertation, Utrecht, 1964. 10.. Oepkes D. Indicaties echoscopisch onderzoek in de zwangerschap. In: Nota
Echosopiee Gynaecologie/Verloskunde. NVOG. Utrecht, 1993:15-22.
11.. Fleuren M. Managing (imminent) miscarriage in primary health care. Dissertation, Amsterdam,, 1997.
12.. Ankum WM, Veen van der F. Management of first-trimester a b o r t i o n . Lancet 1995;345:1179. .
13.. The management of early pregnancy loss. Guideline no 25. Royal College of Obstetricianss and Gynaecologists. London, 2000.
