Bleeding in the first trimester of pregnancy - CHAPTER 7 The natural course of spontaneous miscarriage analysis of signs and symptoms in 188 expectantly managed women

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Bleeding in the first trimester of pregnancy

Wieringa-de Waard, M.

Publication date

2002

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Citation for published version (APA):

Wieringa-de Waard, M. (2002). Bleeding in the first trimester of pregnancy.

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CHAPTERR 7

Thee natural course of spontaneous

miscarriage e

analysisanalysis of signs and symptoms in 188 expectantiy

managedmanaged women

Margreett Wieringa-de Waard, Willem M. Ankum, Gouke J. Bonsel, Jeroen Vos,, Petra Biewenga, Patrick J.E. Bindels

Submittedd for publication Abstract t

OBJECTIVESS To assess the pattern of vaginal bleeding and pain in expectantly managed womenn with a miscarriage, and to analyse the factors predictive of a relatively quick spontaneouss loss.

DESIGNN Part of a randomised controlled trial comparing expectant management withh surgical evacuation and an observational study.

SETTINGG Two Amsterdam hospitals.

PARTICIPANTSS Expectantly managed women with a miscarriage.

RESULTSS Of the 188 expectantly managed women 95 (51 %) experienced a sponta-neouss loss of their pregnancy. In women with bleeding at inclusion, 52% had a suc-cessfull spontaneous loss while of the women without bleeding but with a coinciden-tallyy diagnosed non-viable pregnancy during routine ultrasonographic examination, 46%% had a successful spontaneous loss. In the multivariate analysis an increasing bleedingg pattern at inclusion was predictive of a relatively quick spontaneous loss. Thee median daily levels of bleeding and pain were the most prominent during the firstt eight days after the start of the bleeding and decreased thereafter.

CONCLUSIONSS Expectant management is effective in 5 1 % of unselected women withh a miscarriage. An increasing bleeding pattern is predictive of a relatively quick spontaneouss loss in first-trimester miscarriages. The graphical representation of our findingss can now be used to inform women about the natural course of miscarriages, andd in reaching a well informed treatment choice.

CHAPTERCHAPTER 7

Introduction n

T w oo out o f t e n p r e g n a n t women suffer a period of vaginal b l e e d i n g d u r i n g t h e firstt t r i m e s t e r of t h e i r pregnancy. In 5 0 % of t h e s e cases t h e p r e g n a n c y is v i a b l e ,, d e s p i t e t h e fact t h a t t h e bleeding c o n t i n u e s for a v a r i a b l e period of t i m e .. T h e r e m a i n i n g 5 0 % will miscarry sooner or l a t e r .1 _{E x p e c t a n t m a n a g e} -m e n tt is, in t h e l a t t e r c a s e , increasingly a c c e p t e d as a safe a l t e r n a t i v e for sur-gicall e v a c u a t i o n .2 H o w e v e r , the availability of data on t h e n a t u r a l course of m i s c a r r i a g e s ,, which is n e e d e d to inform t h e s e women a b o u t w h a t to expect in o r d e rr to m a k e an 'informed shared m a n a g e m e n t d e c i s i o n ' , is only l i m i t e d .3 T h i ss s t u d y tries to provide t h e missing information by s t u d y i n g p a t t e r n s of b l e e d i n gg and pain d u r i n g e x p e c t a n t m a n a g e m e n t , and a n a l y s i n g t h e factors p r e d i c t i v ee of a quick spontaneous loss in first-trimester m i s c a r r i a g e s .

Methods s

Patients Patients

Thiss study was part of a larger study conducted between April 1998 and Septem-berr 2000 in two A m s t e r d a m hospitals: the Academic Medical C e n t e r and the Onzee Lieve Vrouwe Gasthuis. Women with a non-viable pregnancy or an incom-p l e t ee miscarriage w e r e asked to incom-particiincom-pate in a randomised controlled trial to c o m p a r ee the safety and effectiveness 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 .. W o m e n who refused randomisation were managed according to t h e i rr own choice. E n r o l m e n t took place among women who a t t e n d e d the emer-gencyy d e p a r t m e n t or t h e outpatient clinic of one of these hospitals because of

first-trimesterfirst-trimester vaginal bleeding after referral by their GPs. W o m e n without vaginall bleeding b u t with a non-viable pregnancy t h a t had been diagnosed coin-cidentallyy during ultrasonographic examination for other purposes, w e r e also included.. Inclusion criteria were: an established diagnosis of a non-viable preg-nancyy or an incomplete miscarriage at a gestational age of less t h a n 16 weeks of pregnancy.. T r a n s v a g i n a l sonographic criteria for this diagnosis were: a mean gestationall sac d i a m e t e r of more than 15 m m without a m e a s u r a b l e embryonic pole,, an e m b r y o without cardiac activity, or a gestational sac d i a m e t e r of less t h a nn 15 mm, not showing any growth after a seven-day interval.4-5 An incom-pletee miscarriage was diagnosed in case of ultrasonographic evidence of retained p r o d u c t ss of conception of m o r e than 15 mm (anterior-posterior d i a m e t e r ) . All transvaginal-scanss w e r e performed b y trained physicians using a transvaginal 6.55 M H z sonographic probe (Hitachi Corporation, Tokyo, J a p a n ) .

Alll w o m e n who w e r e r a n d o m l y assigned to e x p e c t a n t m a n a g e m e n t or had c h o s e nn this t r e a t m e n t option p a r t i c i p a t e d in this study. Exclusion c r i t e r i a w e r e :: inability to u n d e r s t a n d the D u t c h or English informed c o n s e n t form, s e v e r ee b l e e d i n g , pain or fever necessitating i m m e d i a t e surgical e v a c u a t i o n . T h ee s t u d y was a p p r o v e d by t h e medical ethics c o m m i t t e e s of both h o s p i t a l s .

TheThe natural course of spontaneous miscarriage

Follow-up Follow-up

Expectantt management involved bi-weekly scheduled visits to the outpatient clinic.. Further management in this group depended on clinical development. Women,, who became impatient while being managed expectantly and requested surgicall evacuation as yet, were scheduled to undergo a curettage within a week. Alll women were assessed clinically and sonographically during the bi-weekly appointmentss until complete evacuation of the uterus had occurred after eitherr surgical evacuation or a spontaneous loss. Evacuation was considered ass completed if the uterine contents were smaller than 15 mm (anterior-pos-teriorr diameter) at ultrasonography. Women had access to a telephone con-sultationn at all times, and emergency admission could be arranged whenever necessary. .

DataData collection

Duringg the first visit the attending physician collected base line data on clini-call signs and symptoms, obstetric history and gestational age. Additional in-formationn on symptoms and sociodemographic data was collected by means of aa patient questionnaire.

Alll patients were asked to report the amount of bleeding and the degree of ab-dominall pain in a standardised diary. Bleeding was registered daily on a vali-datedd pictorial blood loss assessment chart. Women were asked to register thee number and degree of saturation of tampons and towels used per day. We gavee a score of 1 ml for each lightly stained tampon, 5 ml for a moderately soiledd tampon and 10 ml for a completely saturated tampon. The scores for towelss were 1, 5 and 20 respectively; scores for small and large blood clots weree 1 and 5 respectively.6 7 Pain was scored daily on a visual analogue scale fromm 0 to 100. During the bi-weekly visits the diaries were taken in, and instructionss about the diary for the next interval were given to the patients. StatisticalStatistical analysis

Wee estimated the daily bleeding and pain profile of women with a successful spontaneouss loss of products of conception. Daily blood loss scores were esti-matedd with the use of the pictorial chart and categorised as follows: spotting (2.55 ml), light (5.7 ml), moderate (16.1 ml) and heavy (22 ml).8

Characteristicss and time until spontaneous loss of women who completed a diaryy were compared with those who did not. We regarded the date of self-reportedd tissue loss as the true date of spontaneous loss whenever this was confirmedd ultrasonographically during the next visit to our unit.

Characteristicss and complaints at inclusion were compared between women whoo received expectant management according to randomised treatment allo-cationn and those women who refused randomisation and were managed expectantlyy according to their own choice. Furthermore, we compared char-acteristicss and complaints at inclusion between women who had successfully

CHAPTERCHAPTER 7

experiencedd a spontaneous loss, and those undergoing surgical evacuation later onn at their own request or as an emergency procedure (unscheduled curet-tage).. This analysis was stratified in two groups, with and without bleeding at presentationn (we expected the clinical course to be different between these groups).. Survival analysis was used to describe the cumulative probability of aa spontaneous loss of pregnancy; statistical testing of potential predictors was donee by applying the log-rank test. Women undergoing surgical evacuation (vacuumm curettage) were censored in this analysis at the date of curettage. Womenn undergoing surgical evacuation as an emergency procedure were includedd in two ways: either censored or analysed in the spontaneous loss group.. Variables associated with a spontaneous loss in univariate analyses (p<0.10)) were checked for correlation. The selected set of potential predic-torss was included in a multivariate survival analysis (Cox's proportional haz-ardss model). Age and gestational age were treated as categorical and continu-ouss variable, respectively. The multivariate analysis was restricted to women withh bleeding at inclusion as explained in the text.

Thee Statistical Package of the Social Sciences (SPSS, version 10.07) was usedd for all analyses.

Results s

Off 1101 women who visited our unit with first-trimester pregnancy problems, 2155 (20%) already had miscarried completely and 447 (42%) had an incom-pletee miscarriage or a non-viable pregnancy. Five percent (22/447) were excludedd from the study because of severe bleeding or pain necessitating an immediatee curettage. Of the remaining 425 women, 188 (44%) were managed expectantly. .

Tablee 7.1 shows the characteristics and clinical signs at inclusion of the various groups.. There were no differences between the group randomised to expectant managementt and the group that had chosen to undergo this treatment.

Off the 188 expectantly managed women 95 (51%) experienced a spontaneous losss and 93 (49%) ultimately underwent surgical evacuation; of this latter groupp 70 women were treated on their own request 23 women underwent an emergencyy procedure (Table 7.2).

Univariatee and multivariate analyses were only performed in women with bleedingg at inclusion, because the non-bleeding group was too small (n = 46) forr regression analysis.

Inn the bleeding group we selected the following variables (p<0.10) for the mul-tivariatee analysis: presence of gestational sac on ultrasound, course and amount off bleeding (compared to normal period) and presence of abdominal pain. Tablee 7.3 shows that the course of bleeding was the only variable significant-lyy predictive of a quicker spontaneous loss in women with bleeding with a hazardd ratio of 0.69 (95% CI 0.52-0.93). After adding women with an

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CHAPTERCHAPTER 7

Tablee 7.3. Multivariate proportional hazards model of factors determining spontaneous loss of

miscarriagee in women with bleeding at inclusion.

Modell Factors Hazard ratio P-value

Spontaneouss loss Increasing bleeding 0.69 (0.52-0.93) 0.01 Spontaneouss loss and

emergencyy curettages Increasing bleeding 0.71(0.53-0.94) 0.02 Increasingg amount of bleeding 0.76(0.58-0.99) 0.04

gencyy curettage to the dataset, both the course of bleeding (hazard ratio: 0.71) andd the amount of bleeding (hazard ratio: 0.76) emerged as statistically sig-nificantt predictors.

Off the 95 women with a spontaneous loss, 60 (63%) completed the diary. Of sixx women the data are not included because these women could not report thee moment of spontaneous loss. Time until event (i.e. spontaneous loss or curettage)) was not different for women who completed the diary and those whoo did not.

Figuree 7.1 describes the daily amount of bleeding (in ml) and the severity of painn of women who experienced a spontaneous loss. Data are synchronised forr the first day of vaginal bleeding. In addition, the cumulative proportion of womenn experiencing a spontaneous loss is represented in the figure. Median bloodd loss and pain were heaviest on the third day of vaginal bleeding and steeplyy decreased very fast after eight days to much lower level characterised byy slight bleeding and spotting (5-2 ml/day) from day 12 onward. Of the describedd group 50% miscarried completely during the first eight days.

Discussion n

Inn an unselected group of 188 women with a non-viable pregnancy or incom-pletee miscarriage, about half (95; 51%) of the women experienced a success-full complete spontaneous loss, apparently unrelated to bleeding status at inclusion. .

Iff bleeding occurred, further increase of bleeding prompted spontaneous loss. Noo other characteristics were predictive for a quick spontaneous loss. The dailyy amount of bleeding and pain were most pronounced during the first eightt days of the vaginal bleeding and steeply declined after this period. Att inclusion 215 women had already a complete miscarriage. If we regard thesee cases as well as successful expectant management, the success rate wouldd have been 77% (310/403).

Thee possibility to identify women for whom expectant management is feasible hass previously been explored by Nielsen et al.9 In an RCT they compared

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CHAPTERCHAPTER 7

e x p e c t a n tt and surgical m a n a g e m e n t in w o m e n with i n c o m p l e t e miscarriages a n dd d e v e l o p e d a logistic model including s e r u m h C G , p r o g e s t e r o n e levels a n dd i n t r a - u t e r i n e v o l u m e . In our s t u d y , g e s t a t i o n a l age or i n t r a - u t e r i n e vol-u m ee was not significantly different in women with or withovol-ut a s p o n t a n e o vol-u s loss.. Our s t u d y differed from Nielsen's on two crucial p o i n t s . F i r s t l y , we i n c l u d e dd all w o m e n with a miscarriage as t h e y p r e s e n t in t h e regular p r a c t i c e , whilee N i e l s e n ' s s t u d y r e s t r i c t e d the inclusion to women with incomplete mis-c a r r i a g e s .. Semis-condly, t h e duration of e x p e mis-c t a n t m a n a g e m e n t was mumis-ch longer inn t h e p r e s e n t s t u d y , while Nielsen's waited for only t h r e e d a y s .

Ourr d a t a w e r e b a s e d e n t i r e l y on self-reported s y m p t o m s a n d as a result, our s t u d yy has s o m e l i m i t a t i o n s . W e used the p a t i e n t s ' own a s s e s s m e n t of vaginal b l e e d i n gg as s u b s t a n t i a t e d by the pictorial c h a r t s . T h e reliability of our find-ings,, t h e r e f o r e strongly d e p e n d s from the a c c u r a c y of this r e g i s t r a t i o n . T h e r e l i a b i l i t yy of pictorial c h a r t s , has b e e n criticised in a p r e v i o u s p a p e r studying t h e i rr use in t h e e v a l u a t i o n of m e n o r r h a g i a .1 0

H o w e v e r ,, in our opinion t h e pictorial c h a r t s a r e an easy and patient-friendly m e t h o dd to c o m p a r e vaginal bleeding p a t t e r n s in and a m o n g p a t i e n t s t h e r e b y a c c e p t i n gg its l i m i t a t i o n s .

W ee allowed women to use tampons and towels of t h e i r own choice, without p r o v i d i n gg one s t a n d a r d t y p e of towel and t a m p o n , which e a r l i e r has been shownn to b e useful.1 1 Following this a p p r o a c h , we m a y h a v e u n d e r e s t i m a t e d t h ee t o t a l a m o u n t of blood loss, as h a s b e e n observed by o t h e r s .1 2

Ourr d a t a , for t h e first t i m e ever, i l l u s t r a t e the n a t u r a l course of s p o n t a n e o u s m i s c a r r i a g e ss as r e g i s t e r e d a n d experienced by p a t i e n t s t h e m s e l v e s . T h e graphicall r e p r e s e n t a t i o n of vaginal b l e e d i n g and pain m a y b e useful in counsellingg w o m e n a b o u t t h e expectant m a n a g e m e n t of m i s c a r r i a g e , and in r e a c h -ingg a well informed t r e a t m e n t choice.

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.. Nielsen S, Hahlin M. Expectant management of first-trimester spontaneous abortion. Lancett 1995;345:84-6.

3.. Wiebe E, Janssen P. Conservative management of spontaneous abortions. Women's experiences.. Can Fam Physician 1999;45:2355-60.

4.. Coulam CB, Goodman C, Dorfmann A. Comparison of ultrasonographic findings in spontaneouss abortions with normal and abnormal karyotypes. Hum Reprod 1997;12:823-6. .

5.. Deaton JL, Honore GM, Huffman CS, Bauguess P. Early transvaginal ultrasound followingg an accurately dated pregnancy: the importance of finding a yolk sac or fetal heartt motion. Hum Reprod 1997;12:2820-3.

TheThe natural course of spontaneous miscarriage

6.. Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pic-toriall chart. Br J Obstet Gynaecol 1990;97:734-9.

7.. Janssen CA, Scholten PC, Heintz AP. A simple visual assessment technique to dis-criminatee between menorrhagia and normal menstrual blood loss. Obstet Gynecol 1995;85:977-82. .

8.. Fraser IS, McCarron G, Markham R. A preliminary study of factors influencing per-ceptionn of menstrual blood loss volume. Am J Obstet Gynecol 1984;149:788-93. 9.. Nielsen S, Hahlin M, Oden A. Using a logistic model to identify women with

first-trimesterr spontaneous abortion suitable for expectant management. Br J Obstet Gynaecoll 1996;103:1230-5.

10.. Reid PC, Coker A, Coltart R. Assessment of menstrual blood loss using a pictorial chart:: a validation study. Br J Obstet Gynaecol 2000;107:320-2.

11.. Deeny M, Davis JA. Assessment of menstrual blood loss in women referred for endometriall ablation. Eur J Obstet Gyneco Reprod Biol 1994;57:179-80.

12.. Wyatt KM, Dimmock PW, Walker TJ, O'Brien SPM. Determination of total menstrual bloodd loss. Fertil Steril 2001 ;76:125-31.