International Journal of Gynecology and Obstetrics 83 (2003) 59

Article

Manual vacuum aspiration for second-trimester pregnancy termination

C.S. Todd, M.E. Soler, L. Castleman, M.K. Rogers, P.D. Blumenthal*
Department of Obstetrics and Gynecology, Johns Hopkins Bayview Medical Center, Johns Hopkins University, Baltimore, MD, USA Received 24 March 2003; received in revised form 22 May 2003; accepted 28 May 2003

Abstract Objectives: To compare manual and electric vacuum aspiration for surgical abortions between 14 and 18 weeks of pregnancy. Methods: A consecutive case series of pregnant women presenting to Johns Hopkins Bayview Medical Center for abortion. There were 73 women in the manual vacuum aspiration group and 37 women in the electric vacuum aspiration group. Dilatation and evacuation was performed using manual or electric vacuum aspiration according to protocol. Procedure time was assessed with the t-test. Results: In all cases, abortion was performed with initial vacuum. Group sizes were sufficient to detect a 20% difference in mean procedure time with 80% power (calculated with two separate S.D.s for procedure time). There was no significant difference in procedure time between the two groups. Conclusions: Manual vacuum aspiration can be safely and effectively used in secondtrimester abortion procedures and should be more widely investigated for this purpose. 2003 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
Keywords: Manual vacuum aspiration; Second-trimester abortion; Dilatation and evacuation

1. Introduction Manual vacuum aspiration (MVA) has been shown to be a safe and effective option for patients seeking surgical abortion in the first trimester w1,2x. This method is particularly well suited for situations in which electricity and electric medical equipment are not available or reliable. In the United States, 12% of all abortions are performed in the second trimester, principally by
*Corresponding author. Tel.: q1-410-550-7591; fax: q1410-550-0245. E-mail address: pblumen@jhmi.edu (P.D. Blumenthal).

the dilatation and evacuation (D&E) procedure involving the use of electrically generated suction aspiration w3x. In developing countries, however, electric vacuum aspiration machines for secondtrimester procedures often are not available; neither, in fact, is electricity. Therefore, prior to the implementation of a program designed to introduce safe early second-trimester abortion procedures in Vietnam, we adapted our abortion technique to the clinical setting of that country. We then compared the efficacy of the revised technique with that of the standard procedure we had performed at our institution w4x. The standard procedure for D&E at

0020-7292/03/$30.00 2003 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. doi:10.1016/S0020-7292(03)00304-7

C.S. Todd et al. / International Journal of Gynecology and Obstetrics 83 (2003) 59

our institution and much of the United States is cervical preparation with laminaria, electric vacuum aspiration (EVA), and instrumental evacuation. The purpose of this study was to assess the safety and feasibility of MVA in women undergoing pregnancy termination between 14 and 18 weeks of pregnancy. 2. Methods To assess the safety and feasibility of the procedure, a retrospective review was performed on second-trimester abortions performed at Johns Hopkins Bayview Medical Center between January 1998 and September 2000. The Institutional Review Board for Human Subjects Research approved the data collection for this retrospective study and informed consent was obtained for the procedure. In review of the clinic log book in which all pregnancy terminations performed at JHBMC are recorded, 181 patients were determined to be eligible by meeting the criteria of gestational age between 14 and 18 weeks and completed MVA or EVA procedure. For these 181 cases, 110 charts of patients meeting the study criteria were available from the medical records department for review. The MVA group consisted of 73 patients and the EVA group consisted of 37 patients. Of the four separate providers in this data set, one had more than 10 years experience and the other three were within 2 years of finishing residency. A single experienced provider performed 63 of the procedures listed in the data set and the less experienced providers performed 47. Laminaria were inserted on the afternoon before the procedure by the faculty clinicians. Laminaria could be inserted the afternoon or the morning before the procedure by faculty clinicians. As many large-sized laminaria were inserted as the cervical os could accommodate without exerting excessive force, or a dose of 600 mg of misoprostol was given buccally approximately 2 h before the procedure. Physicians did not significantly predict the cervical ripening method used (33% of experienced providers and 42.5% of less experienced providers used misoprostol). Anesthesia was achieved either through local paracervical block with lidocaine alone or with addi-

tion of intravenous sedation with fentanyl and midazolam, depending subjectively on the tolerance of the patient. Dilatation and evacuation was then initiated using either manual or electric vacuum aspiration, followed by removal of fetal parts as necessary with appropriate forceps. Whether MVA or EVA was used as the suction source, a 12-,14-, or 16-mm diameter cannula was used with the suction source depending on the gestational age, the preference of the surgeon, and the pliability of the cervix. For EVA procedures, if a 14- or 16-mm cannula was used, a reducing adapter was fitted to the cannula, which allowed the use of standard size (1-mm diameter) tubing with the suction machine. When MVA was used, 14- or 16mm cannulae could also be attached to the syringe by using the same reducing adapter. The choice of suction source was determined by the chronology of the procedure, as there was a shift from EVA to MVA between spring and fall of 1999. Information abstracted at chart review included age and parity of the patient, gestational age, type of anesthesia, dilatation and suction methods, and procedure time. Procedure time was routinely recorded by the assisting nurse. It was defined as the period from speculum insertion to speculum removal at end of the procedure, and includes the time required to inspect the products of conception and insure specimen completeness. The results were analyzed with the paired t-test, with statistical significance defined as PF0.05 (Systat Software; SPSS Corporation, Chicago, IL). 3. Results From the 110 available charts reviewed, the mean age of all patients was 23.4 years, the mean parity was 1.4 deliveries, and the mean gestational age was 16 weeks. The patients in the study group did not differ significantly from those whose charts were not recovered for review with respect to age (mean, 24.9 years; Ps0.15), parity (mean,1.69; Ps0.16), or gestational age (mean, 15.8 weeks; Ps0.37). There were no statistically or clinically significant differences between the patients who received EVA and those who received MVA. For the MVA group, the mean age was 23.0 years, the mean

C.S. Todd et al. / International Journal of Gynecology and Obstetrics 83 (2003) 59 Table 1 Mean time of procedure by method type Procedure time (min) Procedure type MVA Mean"S.D. N, significance 18.8"8.6 73 EVA 16.6"8.2 37 Ps0.2

parity was 1.3 deliveries, and the mean gestational age at time of procedure was 16 weeks. For the EVA group, the mean age was 24.2 years, the mean parity was 1.6 deliveries, and the mean gestational age was 15 weeks and 4 days. Cervical preparation was effected with either laminaria or misoprostol; there was no significant difference in procedure time between the preparation methods and the MVA or EVA groups. No MVA cases required resorting to an electric vacuum source and complete abortion was achieved in all cases. The group size was sufficient to allow the detection of a 20% difference in mean procedure time with 80% power (calculated with two separate S.D.s for procedure time). None of the charts reviewed involved immediately recognized complications of hemorrhage or perforation; additionally, none of the reviewed charts contained documentation of visits to the Emergency Department or admission to the gynecology service for complications following the day of surgery at our institution. There is no system in place to determine if late complications presented to an outside hospital; however, the very limited access of our patient population to alternative institutions makes this unlikely. Still, there were no notations of a post-procedure complication in any of the follow-up notes from our termination clinic. The groups were analyzed by procedure, with MVA or EVA. Time of procedure was compared between the two groups without variable adjustment, and no significant difference was detected (Ps0.2) (Table 1). However, when procedure time was analyzed by weeks of gestation, there was an expected trend of increasing procedure time as gestational age increased, and the difference between 14 weeks and all other gestational ages for the MVA group achieved significance (P, 0.0110.001). Nevertheless, Fig. 1 shows that

within gestational age groups, the quantile plots for procedure time for MVA and EVA procedures are virtually identical. The type of anesthesia was divided evenly between the two groups (21.62% of women received local anesthesia alone in the EVA group, vs. 21.92% in the MVA group), and it did not affect procedure time (Ps0.6). The data were also analyzed by the provider, as there were providers of varying levels of experience. There was a significant difference between procedure times when adjusting for the providers experience in both the MVA and EVA groups (P-0.001 and Ps0.02, respectively), with the more experienced providers (those with more than 2 years experience in performing second-trimester procedures) recording shorter procedure times. There was no significant difference in time between the EVA and MVA groups when comparing different procedures done by the same provider (Table 2). 4. Conclusion For the last 20 years, D&E with electrical suction has been the most widely performed procedure for early second-trimester pregnancy termination in the United States w5,7x. However, EVA requires special equipment and electricity, which may not be available in some settings, particularly in developing countries. Additionally, electrical

Fig. 1. Quantile plot of gestational age by vacuum method. Ellipses represent 95% confidence interval of the mean for each plot.

C.S. Todd et al. / International Journal of Gynecology and Obstetrics 83 (2003) 59

Table 2 Mean procedure time adjusted for provider experience Provider Procedure type EVA All providers Mean"S.D. (min) Median, n Most experienced provider Mean"S.D. (min) Median, n Significance of experienced compared to all providers 16.42"8.82 15, ns35 13.87"4.6 12, ns23 Ps0.0156 MVA 20"8.94 17, ns38 14.8"4.24 15, ns20 Ps0.004

suction sources may be less acceptable to patients because of the noise w6x. Therefore, MVA was assessed as the suction component of the procedure to determine if it was as effective. If EVA were perceived (or, by protocol, mandated) to be a requirement in performing D&E, providers in many countries would need to resort to another procedure, likely one that is less safe and effective than D&E. However, if MVA could be demonstrated to provide adequate suction and to be safe, effective, and expeditious, it might be possible to introduce this procedure into settings where EVA is not readily available. Our data indicate that when MVA was compared with EVA in terms of procedure time or ability to complete the procedure, no significant differences were found between the two techniques. This appears to be true even when the agent used for cervical preparation (laminaria or misoprostol) and parity were individually considered. The suction techniques differ very little from each other, and this is reflected by the similarity of the procedure times in the MVA and EVA groups. It is interesting that another study found a significant difference between MVA and EVA procedure time, though this study investigated only first-trimester procedures and was a randomized controlled trial w6x. However, in that study, according to the authors, the time taken to examine the specimen was not incorporated into the procedure time for the EVA procedures, while it was included in the MVA procedures. We acknowledge that our sample numbers are small and it is possible that a larger

sample may result in a significant difference in procedure time between MVA and EVA and y or gestational age. Additionally, there were no immediate or late complications in our cohort. While it is possible that patients may have gone to an outside hospital for a late complication without following-up at our institution, the nature of health financing in our area and the health care facilities accessible to most of our patients makes this unlikely. It is possible that a larger cohort would better define the safety of this procedure. Predictably, both gestational age and provider experience affect procedure time. It is not surprising that procedure time increases with gestational age, and this occurred in both suction-source groups. This was due to the increased volume of uterine contents with advancing gestational age rather than a discrepancy between the suction sources. Provider experience contributed significantly to differences in procedure time for both techniques (MVA, Ps0.001; EVA, Ps0.02). This has been corroborated by several studies and is an important factor in assessing the safety of surgical second-trimester abortion w57x. It is possible that the less-experienced providers spend more time on tissue examination although their instrumentation time is similar to that of an experienced provider; these phases of the procedure were not timed separately and this may represent a hidden bias in our assessment. We acknowledge that some may dispute the validity of our findings, as this was not a randomized controlled trial design. However, because the two groups were virtually identical with respect to age, parity, and gestational age, we feel that randomization would have made little if any difference in the results. In conclusion, our data indicate that MVA is a safe and effective alternative to EVA in providing the suction component of the D&E procedure. Based on other reports regarding noise perception w6,8x and pain perception w9x, MVA is highly acceptable to patients in the United States. In settings where electricity and equipment are unavailable or unreliable, MVA techniques coupled with instrumental extraction may be the safest and most expeditious option for second-trimester abortions. Larger studies, either observational or randomized, particularly in limited resource areas,

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could shed further light on this promising technique. References

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