Bleeding in the first trimester of pregnancy - CHAPTER 2 Management of spontaneous miscarriage in the first trimester an example of putting informed shared decision making into practice

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.

CHAPTERR 2

Managementt of spontaneous miscarriage

inn the first trimester

anan example of putting informed shared decision

makingmaking into practice

Willemm M. Ankum, Margreet Wieringa-de Waard, Patrick J.E. Bindels BMJJ 2001;322:1343-6

Introduction n

Inn many parts of the Western world there is a strong preference among gynae-cologistss to rely on surgical evacuation for the management of miscarriages in thee first trimester. Why so many specialists have adopted surgery as the stan-dardd procedure seems determined by custom and habit and rooted in history ratherr than being an evidence based choice. During the first half of the 20t h centuryy the high rate of infections from retained products of conception with ensuingg mortality from septicaemia -often complications from criminal attemptss to terminate a pregnancy- resulted in the policy of immediate surgi-call evacuation whenever a diagnosis of inevitable abortion was made.1 Today thesee complications are rare, and their role in the justification of a universal tendencyy to perform surgery, has therefore expired.2

Expectantt management finds its main protagonists in general practice, where thee process of spontaneous miscarriage is acknowledged more readily as being aa well regulated natural process in human reproduction.

Relativelyy new is the medical approach to spontaneous miscarriages.3 The combinationn of the antiprogestagen mifepristone and the prostaglandin ana-loguee misoprostol is being used successfully for the termination of pregnan-ciess on a large scale. The use of these substances has also been tried in the managementt of spontaneous miscarriage.

Doctorss and patients are confronted with a situation where opinions about the properr management of spontaneous miscarriage differ widely. That the avail-ablee options are so diverse makes it even more complex. This paper aims to increasee the awareness of various management options and explores the availablee evidence.

Methods s

Wee performed a search in Medline, Embase, the Cochrane Library, and PubMed too identify relevant literature, using spontaneous abortion and spontaneous miscarriagee as primary search conditions for titles and abstracts. We carried outt a crossover search from the obtained articles.

Studiess from primary care

Inn 1989 the Dutch College of General Practitioners issued a practice guideline basedd on the expectant management of spontaneous miscarriage. A revised guideline,, issued in 1997, confirmed expectant management as the strategy off first choice.4-5 Several observational studies from the United Kingdom, Canada,, and the United States have also advocated expectant management by doctorss as a feasible option.6 8 These studies showed that a major proportion of womenn with spontaneous miscarriages, a quarter in the United Kingdom and almostt half in the North American studies, were managed successfully by doctors,, either in the general practice or at home. Additionally, these studies showedd that virtually all women under specialist care were bound to undergo surgicall evacuation. Through an education programme focussing on both doc-torss and patients in Vancouver, British Columbia, surgical evacuations were reducedd from 46% to 32%, and the incidence of complications even decreased duringg the study.9

Thesee studies neither allow any conclusions about the differences between expectantt and surgical management nor between the management in primary andd secondary care, as it is likely that more serious cases were referred to hospital.. They do, however, illustrate that expectant management is being practisedd widely in primary care, even in communities with a high rate of sur-gicall intervention in the hospital environment.

Hospitall based studies

Severall hospital based randomised controlled trials comparing the various managementt options for spontaneous miscarriage are now available and pro-videe more solid ground for management decisions. The Table summarises the resultss of these trials.

Expectantt management versus surgical evacuation

Nielsenn and Hahlin published the first randomised study, which compared expectantt management, during a period of three days, with surgical evacua-tion.1 00 They included women with inevitable and incomplete abortions with anterior-posteriorr diameters greater than 15 mm at ultrasonography. Success

C C O O Ü Ü o o o o co o E E o o "O O c c co o CD' ' co o > > (0 0 c c OO CQ ii > == < Q. . E E o o o o a 75 5 > > 0)) - * V)V) ~ 4)) c WW (0 0) ) 0)) -~

SE E

33 -5 (00 co o» » c c o o EE «O caa * E S S o o o o LO O o o A A CO O LO O ö ö A A LO O ó ó A A CO O O O ó ó LO O ó ó A A CMM -—-LOO O - »» O CMM T -LOO >—' CDD — . , -- O - -- O coo , -f—— ' LO O O O o o V V r --CMM co" (OO o* CMM "*" LO O O O A A CO O i » » co o LO O ó ó A A LO O o o A A LO O o o A A OJ J i » » co o LO O o o ó ó V V LO O o o o o V V LO O 2» » *fr r LO O o o o o _{V V} E E a> > *—* * o o co o LO O O O o o V V E E B B (^^ O) >> o o o CD D E E 2 o o CM co o co o cc g 2 S S 3> CMM co ~~ C CO —' ca a >. . IV)) c *-~~ E CD

S-gg

5

E E EE CD >% COO c w ~~ E ® XX ? 5 E E coo c C OO CD CD ee CD o 5> > "cöö c £* oo CD CD TOO E a> E COO -^ CDD co coo ^ co ^ COO O ) ^ 0 0 COO >_{~ ' LO " "} COO c ^ oo CD 0 T33 E P CMM ^ COO o CMM w co o a> > COO 3 E COO —' CDD co COO c JT OO CD CD T33 E P COO ^ CDD CO LO O ó ó A A CVJ J LO O LO O ó ó A A CMM h» ^^ co c* oT oo 5 i co o^ h -- o> .,_ _ £00 05" coo 92-o 92-o CO O o o t OO CM O)) 55. -*t t coo (F -'t t iSS g Ü Ü CDD = CO O O O EE =5 CD D E E co o 3 3 O O CD D C C co o < -c -c o o Q. . co o c c CD D E E CD D O) ) CO O c c ca a CAA . 2 o o a> > .EE O Q. COO 3 CD

« ? ë ë

oo c a>> CD a ~ ~ >»» co I -- o. o o LO O o o c c COO cD

«f-2 2

>> O o

®® g E

.EE .E co E E E E LO O CM M CD D

Ü Ü

. EE co CDD co NN . *

'

55

s

©© i -^^ v CD D

II I

IS S

T 3 3 CO O o o CD D CD D (O O E E CD D CD D Q . . E E o o o o c c C C O O ^ ^ ^~ ~ ( J J o o CO O E E E E CM M V V E E b b h --CM M cv v E E o o LO O A A ^. . > > co o c c co o E E o o co o A A (Tl l CO O T 3 3 r r CO O o o CD D CO O CD D .3? ? a. . h h o o c c o o n n EE .E "OO <D cc +-caa £ c T33 Q- O CDD £ ï = ww o ^ «« 8 o EE .E « E E E E o o LO O " OO a) cc + -COO © c T33 O- O CDD E ï = ww O « «« 8 o E . EE "co Q. . (8 8 O) ) o o c c o o 4» » co o CM M

z z

co o > o o 3 3 0 ) ) CDD I -U)U) -1 -Cüü ~o CDD co coo CD coo E - CC CO 88 ™ Q-- ^ -—— T3 üü co CD D O ) ) CC _ oo ; ~ 33 - 3 -- CO CD D OO CD c c o o coo m cc r_ x :: co oo *-->-> CD 5 5 co o x : : co o c c CC T-üü <D C C CDD co Ü?? — CDD CO izz »

ratess and complication rates were similar in both groups, as was the duration of vaginall bleeding, pain, sick leave and packed cells volume after 3 and 14 days. Twoo more recent papers from this study showed no differences in psychological reactionss and in subsequent fertility between both cohorts of women.11-12 Chipchasee and Jones did a similar but smaller study among women with retained productss of conception less than 50 mm on transvaginal sonography after spontaneouss miscarriages.1 3 They found no differences between expectant andd surgical management in complication rates, duration of bleeding, pain, or sickk leave.

Medicall treatment versus surgical evacuation

Dee Jonge et al compared medical treatment (a single dose of the prostaglandin analoguee misoprostol) with surgical evacuation.14 Women with inevitable mis-carriagess on clinical grounds were included. Several women were stabilised beforee randomisation: in each treatment arm about one third received blood transfusions.. Medical treatment was considered successful if a complete mis-carriagee occurred within 12 hours. Only 3 of 23 patients (13%) were treated successfullyy with misoprostol compared with 26 of 27 patients (96%) allocat-edd to surgery. Haemoglobin concentrations decreased significantly in women treatedd medically but were stable in those treated surgically. The study was discontinuedd after the present (interim) analysis. Patients entered in this studyy were apparently different from those in the other reports summarised inn this paper. The fairly large uterine size (mean 13 weeks) and considerable proportionn of women requiring blood transfusions before randomisation prob-ablyy explain the high failure rate of medical treatment in this study.

Johnsonn et al compared medical treatment with surgical evacuation in women withh miscarriages in the first trimester.1 5 Findings on ultrasonography were nott specified, and included patients were a mixture of symptomatic women withh non-vital pregnancies and incomplete or complete abortions. All patients weree treated successfully in both treatment groups. In each group one major complicationn occurred: a laparotomy was done for a bleeding perforation after surgicall evacuation, and a presumed ectopic pregnancy after medical treat-mentt also resulted in a laparotomy, which did not confirm the diagnosis. Hinshaww compared medical treatment with surgical evacuation in women with missedd and incomplete abortions.16 An open study design was used: patients weree either treated according to the randomised treatment allocation or a-ccordingg to their own preference. Pooled results were reported. Medical man-agementt comprised misoprostol in those with incomplete abortions, whereas thosee with missed abortions were treated with the antiprogestagen mifepris-tone,, followed by misoprostol after a priming phase. In women with small uterinee contents, no difference between medical treatment and surgery was foundd in the rate of complete evacuations. In those with larger uterine contents,

ManagementManagement of spontaneous miscarriage diagnosis* * ultrasonography y vaginall bleeding uterinee pain 22 3 4 5

1:: ultrasonography shows early anembryonic pregnancy or fetal death (missed miscarriage) 2:: vaginal bleeding occurs (threatened miscarriage)

3:: open cervical os (inevitable miscarriage)

4:: miscarriage (products of conception are expelled, cramps and bleeding soon subside) 5:: ultrasonography may show uterine contents: decidua, blood, and some villi

Figuree 2.1. Natural course of miscarriage, with opportunities for intervention.

thee complete evacuation rate was significantly lower in medically treated wom-enn compared with those undergoing surgical evacuation. Overall, three haem-orrhagess greater than 500 ml occurred during medical treatment. In the sur-gicallyy treated women three major complications occurred: one perforation necessitatingg laparotomy with bowel resection and one cervical tear requiring suturing.. The woman with the cervical tear developed sepsis and pelvic infec-tionn and was treated with high dose intravenous antibiotics. Chung et al com-paredd medical management (misoprostol every four hours) with surgical eva-cuationn in women with ultrasonographical evidence of retained products of conceptionn greater than 5cm2 (transverse plane) or greater than 6cm2 (sagit-tall plane).1 7 Patients allocated misoprostol underwent a surgical evacuation thee next day, whenever retained products of conception were still present (as wass the case in 50% of patients). In the group allocated surgical removal, 2% requiredd a second evacuation. There were significantly less short, medium, andd long term complication in the women treated medically. Drug related gastrointestinall side effects occurred in up to 48% of those women.

Expectantt management versus medical therapy

Nielsenn et al were the first to explore the efficacy of expectant versus medical managementt in a randomised trial of women with spontaneous miscarriages in thee first trimester.1 8 Women were either managed expectantly or received mifepristonee followed by misoprostol 48 hours later. After five days, women withh ultrasonographical evidence of retained products of conception greater than

155 mm underwent surgical evacuation. Success rates were similar in both

groups,, as were pain scores, vaginal bleeding, complications, and scores for patient satisfaction.. Convalescence was 1.8 days longer after medical treatment.

Observationall studies

Twoo observational hospital based studies are of special interest:

aa non-randomised study, performed by Cheung et al, provides detailed infor-mationn about short-term complications in a large series of patients.1 9 Women withh complete abortions (n = 297) were managed expectantly, whereas those showingg retained products of conception on ultrasonography (n = 470) were treatedd surgically. Treatment complications after surgery occurred in 6% of women:: two cervical lacerations and four uterine perforations, for which two laparoscopicss were done, whereas another patient needed an emergency hys-terectomyy for uncontrollable pelvic bleeding. Short term complications in thosee managed expectantly occurred in only 3% of women and were less severe,, but the difference did not reach significance compared with those treatedd primarily by surgery.

Inn another observational study by Jurkovic et al, 221 asymptomatic women withh a missed miscarriage diagnosed by ultrasonography were offered a choicee between surgical evacuation and expectant management.2 0 Among 85 womenn (38%) opting for expectant management, 25% experienced a com-pletee miscarriage, whereas 17% needed surgical evacuation because of incompletee miscarriages. The remaining 59% requested surgical evacuation att some later stage, mostly for psychological reasons. The authors conclude thatt the success of expectant management is too low to justify its use in rou-tinee clinical practice.

Conclusion n

Althoughh miscarriage is the most common complication in pregnancy, the availablee evidence on its management is extremely limited. A considerable proportionn of women with spontaneous miscarriages is being managed expec-tantlyy by doctors, even in communities where virtually all patients under sec-ondaryy care are treated by surgical evacuation.

Surgicall intervention in women with complete abortions is unnecessary and representss over treatment. Most studies in the Table simply excluded these patientss from further intervention. Even in women with ultrasonographical evidencee of retained products of conception in the aftermath of a spontaneous miscarriage,, immediate surgery is likely to be unnecessary in most cases, and medicall treatment offers no advantages either. Arguably, clinical rather than ultrasonographicall criteria should be used to indicate the necessity of surgical uterinee evacuation in these patients. In women with no history of passing any

ManagementManagement of spontaneous miscarriage

tissue,, however, an empty uterine cavity on ultrasonography should raise suspicionn of an ectopic pregnancy. In these women, measurements of serum humann chorionic gonadotropin concentrations together with repeated ultra-sonographyy should lead the way in differentiating between a complete mis-carriagee and ectopic pregnancy.21"23

Inn women still facing the process of spontaneous miscarriage there is strong evidencee to suggest expectant management to be a realistic alternative to surgicall evacuation, whereas medical treatment does not seem to offer any advantage.. As mifepristone and misoprostol cause gastrointestinal side effectss in up to 50% of patients and increase costs, these drugs probably deservee no place in the management of spontaneous miscarriage. Therefore, womenn with missed abortions or fetal death in the first trimester should be counselledd accordingly and offered a choice between expectant and surgical management.. This also seems true for women with evidence of non-vital pregnanciess on ultrasonography before the onset of any clinical signs.

Obviously,, patients' preferences should play a key part in these management decisions,, and more research is needed to elucidate the effect of these prefer-encess on the acceptance of different treatment options. There seems, however, noo point in denying a motivated well informed woman a fair chance to await thee natural course of events whenever she prefers to do so. If surgical evacua-tionn becomes necessary for medical or psychological reasons at some later stage,, nothing is lost and at least then the reasons for surgical intervention aree clear. Spontaneous miscarriage is a typical example of a condition, where informed-sharedd decision making should be put into practice thus replacing paternalismm by partnership.2 4"2 6

References s

1.. Ballagh SA, Harris HA, Demasio K. Is curettage needed for uncomplicated incomplete spontaneouss abortion? Am J Obstet Gynecol 1998;179:1279-82.

2.. Why mothers die. Report on confidential enquiries into maternal deaths in the United Kingdomm 1994-1996. The Stationary Office, London, 1998.

3.. El-Refaey H, Hinshaw K, Henshaw R, Smith N, Templeton A. Medical management of missedd abortion and anembryonic pregnancy. BMJ 1992;305:1399.

4.. 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.

5.. 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.

6.. Everett C. Incidence and outcome of bleeding before the 20th week of pregnancy: prospectivee study from general practice. BMJ 1997;315:32-4.

7.7. Ambulatory Sentinel Practice Network. Spontaneous abortion in primary care. J Am

Boardd Fam Pract 1988;1:15-23.

8.. Wiebe E, Janssen P. Management of spontaneous abortion in family practices and hospitals.. Fam Med 1998;30:293-6.

9.. Wiebe E, Janssen P. Reducing surgery in management of spontaneous abortions. Familyy physicians can make a difference. Can Fam Physician 1999;45:2364-9. 10.. Nielsen S, Hahlin M. Expectant management of first-trimester spontaneous abortion.

Lancett 1995;345:84-6.

1 1 .. Nielsen S, Hahlin M, Moller A, Granberg S. Bereavement, grieving and psychological morbidityy after first trimester spontaneous abortion: comparing expectant manage-mentt with surgical evacuation. Hum Reprod 1996;11:1767-70.

12.. Blohm F, Hahlin M, Nielsen S, Milsom I. Fertility after a randomised trial of sponta-neouss abortion managed by surgical evacuation or expectant treatment. Lancet 1997;349:995. .

13.. Chipchase J, James D. Randomised trial of expectant versus surgical management of spontaneouss miscarriage. Br J Obstet Gynaecol 1997;104:840-1.

14.. De Jonge ETM, Makim JD, Manefeldt E, De Wet GH, Pattinson RC. Randomised clinicall trial of medical evacuation and surgical curettage for incomplete miscarriage. BMJJ 1995;311:662.

15.. Johnson N, Priestnall M, Marsay T, Ballard P, Watters J. A randomised trial evaluat-ingg pain and bleeding after first trimester miscarriage treated surgically or medical-ly.. Eur J Obstet Gynecol Reprod Biol 1997;72:213-5.

16.. Hinshaw HKS. Medical management of miscarriage. In: Grudzinskas JG, O'Brien PMS, eds.. Problems in early pregnancy. London: RCOG Press, 1997:284-95.

17.. Chung TKH, Lee DTS, Cheung LP, Haines CJ, Chang AMZ. Spontaneous abortion: a randomized,, controlled trial comparing surgical evacuation with conservative man-agementt using misoprostol. Fertil Steril 1999;71:1054-9.

18.. Nielsen S, Hahlin M, Platz-Christensen J . Randomised trial comparing expectant withh medical management for first trimester miscarriages. Br J Obstet Gynaecol 1999;106:804-7. .

19.. Cheung LP, Sahota DS, Haines CJ, Chang AMZ. Spontaneous abortion: short term complicationss following either conservative or surgical management. Aust NZ J Obstett Gynaecol 1998;38:61-4.

20.. Jurkovic D, Ross JA, Nicolaides KH. Expectant management of missed miscarriage. Brr J Obstet Gynaecol 1998; 105:670-1.

2 1 .. Ankum WM, Van der Veen F, Hamerlynck JVTH, Lammes FB. Transvaginal sonogra-phyy and human chorionic gonadotrophin measurements in suspected ectopic preg-nancy:: a detailed analysis of a diagnostic approach. Hum Reprod 1993;8:1307-11.

ManagementManagement of spontaneous miscarriage

22.. Bannerjee S, Aslam N, Zosmer N, Woelfer B, Jurkovic D. The expectant management off women with early pregnancy of unknown location. Ultrasound Obstet Gynaecol 1999;14:231-6. .

23.. Ankum WM. Diagnosing suspected ectopic pregnancy; HCG monitoring and transvagi-nall ultrasound lead the way. BMJ 2000;321:1235-6.

24.. Towle A, Godolphin W. Framework for teaching and learning informed shared deci-sionn making. BMJ 1999;319:766-71.

25.. Charles C, Whelan T, Gafni A. What do we mean by partnership in making decisions aboutt treatment? BMJ 1999;319:780-2.

26.. Coulter A. Paternalism or partnership? BMJ 1999;319:719-20.