Manual vacuum aspiration: A safe and effective treatment for early

Surgical management of early pregnancy loss has advantages over medical treatment. For one, patients benefit from a brief procedure using local anesthesia. Here, pearls for office-based surgery as well as other treatment options.

Piyapa Praditpan, MD, MPH, and Anne R. Davis, MD, MPH

CASE Miscarriage in a 29-year-old woman intervention. The management options A woman (G0P0) presents to her gynecologist include surgical, medical, and expectant. with amenorrhea for 3 months and a positive Women should be offered all 3 of these, and home urine pregnancy test. She is 29 years clinicians should explain the risks and bene- of age. She denies any bleeding or pain and fits of each approach. But while each strategy IN THIS intends to continue the pregnancy, though it ARTICLE can be safe, effective, and acceptable, many was unplanned. Results of office ultrasonogra- women, as well as their health care provid- Advantages of phy to assess reveal an intrauter- ers, will benefit from office-based uterine office-based MVA ine gestation with an 8-mm fetal pole but no aspiration. In this article, we present the data page 39 heartbeat. The diagnosis is miscarriage. available on office-based manual vacuum as- piration (MVA) as well as procedure pointers his case illustrates a typical miscar- and urge you to consider MVA in your prac- Medical riage diagnosis; most women with tice for your patients. management T miscarriage are asymptomatic and page 40 without serious bleeding requiring emergency Surgical management Current diagnostic Surgical management of miscarriage offers criteria Dr. Praditpan is Fellow in Family several clear advantages over medical and page 42 Planning, Department of Obstetrics and Gynecology, Columbia University expectant management. Perhaps the most Medical Center, New York, New York. important advantage to patients is that sur- gery offers rapid resolution of miscarriage with the shortest duration of bleeding.1,2 When skilled providers perform electric Dr. Davis is Associate Professor of vacuum aspiration (EVA) or MVA in outpa- Clinical Obstetrics and Gynecology and Director of the Family Planning tient or emergency department settings, suc- Fellowship, New York Presbyterian/ cessful uterine evacuation is completed in a Columbia University Medical Center, single medical encounter 99% of the time.1 By comparison, several follow-up visits and

The authors report no financial relationships relevant to additional ultrasounds may be required dur- this article. ing medical or expectant management. Uter- ine aspiration rarely requires an operating

38 OBG Management | November 2015 | Vol. 27 No. 11 obgmanagement.com room (OR). Such a setting should be limited an OR spent a mean total of 290 minutes at to cases in which the clinical picture reflects: the hospital.5 • hemodynamic instability with active uter- Patients’ satisfaction with care provided ine bleeding in the OR was comparable to patients’ sat- • serious uterine isfaction with care provided in a medical • the presence of medical comorbidities in office. In fact, the median total satisfaction patients who may benefit from additional score was high among women who had a blood bank and anesthesia resources. procedure in either setting (office score, 19 of 20; OR score, 20 of 20).

Office-based MVA Cost and equipment for in-office MVA Office-based MVA is well tolerated when Office-based surgical management of mis- performed using a combination of verbal carriage is more cost-effective than OR- distraction and reassurance, oral nonsteroi- based management. In 2006, Dalton and dal anti-inflammatory drugs (NSAIDs), and colleagues conducted a cost analysis and a paracervical block with or without intrave- found that average charges for office-based nous sedation. MVA were less than half the cost of charges Evidence on managing pain at MVA. for a (D&C) in the OR Multiple studies have assessed preprocedure ($968 vs $1,965, respectively).5 and postprocedure pain using NSAIDs, oral More recently, these researchers found anxiolytics, and local anesthesia at the time that usual care (expectant or OR manage- of EVA or MVA.3,4 Renner and colleagues ment) was more costly than a model that found that women who received a paracervi- also included medical and office-based sur- cal block prior to MVA or EVA reported mod- gical options. They found that the expanded erate levels of pain, according to a 100-point care model—with use of the OR only when visual analogue scale (VAS), at the time of needed—cost $1,033.29 per case. This was (mean, 42) and uterine as- compared with $1,247.58 per case when Office-based MVA 4 piration (mean, 63). In this same study, pa- management options did not include medi- can be performed 6 tients’ willingness to treat a future pregnancy cal and office-based surgical treatments. with local anesthesia with EVA or MVA using local anesthesia and The cost of supplies needed to initiate and is faster their overall satisfaction with the procedure MVA services within an established outpa- than surgical was high (mean, 90 on 100-point VAS). tient gynecologist’s office is modest. Equip- management in In-office advantages over the OR. Women ment includes manual vacuum aspirators; an OR and clinicians can avoid the extensive sched- disposable cannulae of various sizes; reus- uling delays associated with ORs, as well as able plastic or metal dilators; supplies for the complications associated with medical disinfection, allowing reuse of MVA aspira- and expectant management, if office-based tors; and supplies for examination of prod- EVA and MVA services are readily available. ucts of conception (POC; FIGURE 1, page 40). Compared with surgical management of According to WomanCare Global, man- miscarriage in an OR, office-based EVA and ufacturer of the IPAS MVA Plus, equipment MVA are faster to complete. For example, should be sterilized after each use with soap Dalton and colleagues compared patients and water, medical cleaning solution (such undergoing first-trimester procedures in an as Cidex, SPOROX II, etc.), or autoclaving.7 office setting with those undergoing a pro- If 2 reusable aspirators are purchased along cedure in an OR. The mean procedure time with dilators, disposable cannulae, and tools for women treated in an office was 10 min- for tissue assessment, the price of supplies is utes, compared with 19 minutes for wom- estimated at US $500.8 WomanCare Global en treated in the OR. In addition, women also offers prepackaged, single-use aspirator treated in an office setting spent a mean total kits, which may be ideal for the emergency of 97 minutes at the office; women treated in department setting.9 CONTINUED ON PAGE 40

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FIGURE 1 MVA equipment The risk of endometritis after surgical management of miscarriage is low. Antibi- otic prophylaxis prior to MVA or EVA should be considered. Experts recommend giving a single dose of doxycycline 200 mg orally at least 1 hour prior to uterine aspiration.2,10 Use of EVA or MVA for outpatient man- agement of miscarriage yields the opportu- nity to conduct immediate gross examination of the evacuated tissue and to verify the presence of complete POC. The process is simple: rinse the specimen through a sieve with water or saline, placed in a clear glass container under a small water bath and backlit on a light box. This allows clinicians The required equipment for office-based MVA includes a reusable vacuum to separate uterine and pregnancy aspirator (with disinfection supplies), reusable plastic or metal dilators, and tissues. “Floating” tissue in this manner is supplies for examination of . especially useful in patients with pregnancy of unknown location, as immediate confir- The procedure mation of a gestational sac rules out ectopic To view a video on the MVA device and pro- pregnancy. cedure, including step-by-step technique Examine evacuated tissue for macro- (FIGURE 2), local anesthesia administration, scopic evidence of pregnancy. Chorionic choosing cannula size, and cervical dilation, villi, which arise from syncytiotrophoblasts, visit the Managing Early Pregnancy Loss can be seen with the naked eye. Immediate Web site (http://www.earlypregnancyloss evaluation of POC is also useful for patients resources.org) and access “Videos.” The vid- who desire diagnostic testing to ascertain a eo “Uterine aspiration for EPL” is available cause of their miscarriage because evacu- under password protection and broken into ated tissue stored in saline may be sent to a chapters for viewing ease. laboratory for cytogenetic analysis.

FIGURE 2 MVA procedure Medical management Management of miscarriage with misopro- stol is also safe and acceptable to women, though it has a lower success rate than surgi- cal management. Comparing efficacy: Medical vs surgical management. The Management of Early Pregnancy Failure Trial (MEPF) is the larg- est randomized controlled trial comparing medical management of miscarriage to sur- gical management. This multicenter study compared treatment with office-based EVA or MVA to vaginal 800 µg. A re- If the cannula is already inside the , suction should be created in the peat dose of vaginal misoprostol was offered syringe and then the syringe should be attached to the cannula. Suction is 48 hours after the initial dose if a gestational generated when the valves are released. Once the vacuum is activated, the sac was present on ultrasound. cannula is maneuvered in the uterus with a combination of rotation and in and out movements between the fundus and internal os. Findings from the MEPF trial revealed a 71% complete uterine evacuation rate after

40 OBG Management | November 2015 | Vol. 27 No. 11 obgmanagement.com 1 dose of misoprostol and an 84% rate after used misoprostol for management of mis- 2 doses.1 The average (SD) reported pain carriage were more likely to have any bleed- score documented within 48 hours of treat- ing during the 2 weeks after initiation of ment with misoprostol or MVA/EVA was treatment, compared with women who had moderate (5.7 cm [2.4] on 10-cm VAS). The suction aspiration.12 rate of infection or hospitalization was less Clinically significant changes in hemo- than 1% in both treatment groups. globin levels are more common in women These data should provide patients who treated with misoprostol than in those who are clinically stable and who wish to avoid an choose EVA or MVA; however, these differ- invasive procedure reassurance that using ences rarely require hospitalization or trans- medication for the management of miscar- fusion.1 Women who are considering use of riage is a reasonable option. misoprostol should be aware of common Misoprostol. Use of misoprostol is associ- adverse effects, including nausea, vomiting, ated with a longer median duration of bleed- diarrhea, and low-grade temperature. ing compared with suction aspiration. After Medical management of miscarriage misoprostol, bleeding usually begins after requires multiple office visits with repeat several hours and may continue for weeks.11 ultrasounds or serum beta–human chori- Based on 2-week prospective bleeding di- onic gonadotropin (β-hCG) levels to confirm ary entries from the MEPF trial, women who treatment success. In cases of medication

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failure (persistent gestational sac with or assessed perceived prevalence and causes of without bleeding) or suspected retained miscarriage in more than 1,000 US men and POC (endometrial stripe greater than women.14 The majority of respondents be- 30 mm measured on ultrasound or persistent lieved miscarriage is uncommon, occurring vaginal bleeding remote from treatment), in less than 5% of pregnancies. Respondents women should be prepared for surgical reso- also believed stressful events, lifting heavy lution of pregnancy and clinicians should be objects, and prior use of intrauterine or hor- able to perform an office-based procedure. monal contraception are often to blame for pregnancy loss. Despite more than 3 decades of data Expectant management confirming that more than 60% of early losses Women who choose the “watch and wait” are associated with chromosomal abnormal- approach should be advised that the process ities and that an additional 18% may be asso- is unpredictable and occasionally requires ciated with fetal anomalies, women often urgent surgical intervention. Successful res- blame themselves.15 Bardos and colleagues olution of pregnancies that are expectantly found that 47% of women felt guilty about managed depends on the type of miscarriage the experience of miscarriage. diagnosed at initial presentation. Luise and colleagues conducted a prospective study of 451 women with miscarriage who declined Diagnosis: Updated medical and surgical management. They ultrasonography criteria issued found that the watch-and-wait approach was When miscarriage is suspected based on successful in 91% of women with an incom- symptoms of pain and bleeding in preg- plete , 76% of women with missed nancy, obtain a thorough history and con- abortion, and 66% of women with anem- duct a limited physical examination. If an bryonic pregnancies.13 Success was defined intrauterine pregnancy (IUP) was previously Data have long by the absence of vaginal bleeding and an indicated early anterior-posterior endometrial stripe mea- the presence or absence of the gestational identified, a repeat ultrasound can confirm pregnancy loss is suring less than 15 mm 4 weeks after initial sac. If an IUP has not been documented, then due to chromosomal diagnosis of miscarriage. additional studies, including serial serum abnormalities or Like medical management for miscar- β-hCG examinations and ultrasonography, are essential to rule out ectopic pregnancy. fetal anomalies, but riage, expectant management requires mul- tiple office visits plus repeat ultrasounds Rh status should be determined and a 50- g women often feel µ or β-hCG measurement trends to confirm dose of Rh(D)-immune globulin adminis- guilt over the treatment success. Women who fail expect- tered to Rh(D)-unsensitized women within experience ant management will require medical or 72 hours of documented bleeding. surgical intervention to resolve the preg- Ultrasonography is often used to diagnose nancy. For those who are seeking preg- miscarriage. Many gynecologists use ultra- nancy right away, the unpredictability and sound criteria based on studies conducted in longer time to resolution of miscarriage the early 1990s that define nonviability by an may render expectant management anxiety empty gestational sac with mean gestational provoking and unacceptable. sac diameter greater than 16 mm or a crown- rump length (CRL) without evidence of fetal cardiac activity greater than 5 mm.10 In 2012, Etiology: Do true and perceived members of the Society of Radiologists in causes match? Ultrasound Multispecialty Panel on Early Miscarriage during the first 13 weeks of ges- First Trimester Diagnosis of Miscarriage and tation occurs in at least 10% of all clinically Exclusion of a Viable Intrauterine Pregnancy diagnosed pregnancies.10 A recent survey developed more conservative criteria for the administered by Bardos and colleagues diagnosis of miscarriage.16

42 OBG Management | November 2015 | Vol. 27 No. 11 obgmanagement.com Doubilet and colleagues suggested new Culture change is needed cutoffs, based on their reanalysis of 2 large Patients’ beliefs and scientific evidence prospective studies conducted in the United about miscarriage are incongruous. By mak- Kingdom.17 Calculations for these new cut- ing simple changes in practice and providing offs are based on mathematical adjustments straightforward patient education, ObGyns for interobserver variability. Strict adherence can demystify the causes of miscarriage to these more conservative criteria is sensi- and improve its management. In particu- ble when a pregnancy is desired. For women lar, providing office-based MVA when re- who do not want to continue the pregnancy quested can streamline treatment for many there is no medical justification for using this women. For too long, patients have blamed diagnostic process. Indeed, delays can lead themselves for miscarriage and physicians to stress and poor outcomes including emer- have relied on D&C in the OR. Changes gent surgical management for spontaneous in culture surrounding miscarriage are and heavy bleeding. long overdue.

References 1. Zhang J, Gilles JM, Barnhart K, Creinin MD, Westhoff C, management of early pregnancy failure. Am J Emerg Med. Frederick MM. A comparison of medical management with 2013;31(1):244−247. misoprostol and surgical management for early pregnancy 10. Committee on Practice Bulletins—Gynecology, American failure. N Eng J Med. 2005;353(8):761−769. College of Obstetricians and Gynecologists. Practice 2. Paul M, Lichtenberg ES, Borgatta L, Grimes DA, Stubblefield Bulletin No. 150: early pregnancy loss. Obstet Gynecol. PG, Creinin MD, eds. Management of Unintended and 2015;125(5):1258−1267. Abnormal Pregnancy: Comprehensive Abortion Care. 11. Meckstroth KR, Whitaker AK, Bertisch S, Goldberg AB, Oxford, United Kingdom: Wiley-Blackwell; 2009. Darney PD. Misoprostol administered by epithelial routes: 3. Edelman A, Nichols MD, Jensen J. Comparison of pain drug absorption and uterine response. Obstet Gynecol. and time of procedures with two first-trimester abortion 2006;108(3 part 1):582−590. techniques performed by residents and faculty. Am J Obstet 12. Davis AR, Hendlish SK, Westhoff C, et al. Bleeding patterns Gynecol. 2001;184(7):1564−1567. after misoprostol vs surgical treatment of early pregnancy 4. Renner RM, Nichols MD, Jensen JT, Li H, Edelman AB. failure: results from a randomized trial. Am J Obstet Gynecol. Paracervical block for pain control in first-trimester surgical 2007;196(1):31.e31−e37. abortion: a randomized controlled trial. Obstet Gynecol. 13. Luise C, Jermy K, May C, Costello G, Collins WP, Bourne 2012;119(5):1030−1037. TH. Outcome of expectant management of spontaneous 5. Dalton VK, Harris L, Weisman CS, Guire K, Castleman L, first trimester miscarriage: observational study. BMJ. Lebovic D. Patient preferences, satisfaction, and resource 2002;324(7342):873−875. use in office evacuation of early pregnancy failure. Obstet 14. Bardos J, Hercz D, Friedenthal J, Missmer SA, Williams Z. A Gynecol. 2006;108(1):103−110. national survey on public perceptions of miscarriage. Obstet 6. Dalton VK, Liang A, Hutton DW, Zochowski MK, Fendrick Gynecol. 2015;125(6):1313−1320. AM. Beyond usual care: the economic consequences of 15. Practice Committee of the American Society for Reproductive expanding treatment options in early pregnancy loss. Am J Medicine. Evaluation and treatment of recurrent pregnancy Obstet Gynecol. 2015;212(2):177.e171−e176. loss: a committee opinion. Fertil Steril. 2012;98(5):1103−1111. 7. Ipas. Ipas start-up kit for integrating manual vacuum 16. Doubilet PM, Benson CB, Bourne T, Blaivas M. Diagnostic aspiration (MVA) for early pregnancy loss into women’s criteria for nonviable pregnancy early in the first trimester. reproductive healthcare services. Chapel Hill, NC: Ipas; N Eng J Med. 2013;369(15):1443−1451. 2009. 17. Abdallah Y, Daemen A, Kirk E, et al. Limitations of current 8. MVA Products page. HPSRx Web site. http://www.hpsrx definitions of miscarriage using mean gestational sac .com/mva-products.html. Accessed October 13, 2015. diameter and crown–rump length measurements: a 9. Kinariwala M, Quinley KE, Datner EM, Schreiber CA. multicenter observational study. Ultrasound Obstet Gynecol. Manual vacuum aspiration in the emergency department for 2011;38(5):497−502.

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