Journal Logo

Original articles

A randomized controlled trial comparing surgical evacuation of pregnancy with or without ultrasound guidance

Magdy, Ahmed M.; Momtaz, Mohamed; Ramzy, Abdel-Maguid; Zamzam, Maha

Author Information
Evidence Based Women's Health Journal: May 2014 - Volume 4 - Issue 2 - p 96-98
doi: 10.1097/01.EBX.0000440895.84700.e0
  • Free

Abstract

Introduction

Ultrasound-guided evacuation and curettage have recently been used worldwide as a technique to avoid many risk factors and complications that could result from blinded curettage for first-trimester abortions 1.

Since 1996, patients have been offered evacuation of retained products of conception by ultrasound guidance, which was found to be safe, involving lesser bleeding, being less time consuming, and also being associated with less incidence and reduced risk of uterine perforation and other complications such as postevacuation Asherman’s syndrome in addition to the reduced risk for the need of operative intervention such as laparotomy or laparoscopy 2.

The most recent mortality data available (estimated between 2003 and 2007) demonstrate that the mortality resulting from early pregnancy failure has decreased significantly to a 5-year national average of 0.5/100 000 live births in the USA 1.

Investigators included women presenting with postoperative (evacuation) bleeding suspicious by ultrasound of having retained products of conception, and they were elected for ultrasound-guided evacuation. They concluded that extraction of retained products of conception under sonographic guidance resulted in reduced risk of postoperative bleeding by 2–3%, and could therefore be used as an alternative approach to evacuation without ultrasound guidance 3. The aim of the present study was to evaluate the importance of the use of ultrasound in surgical evacuation during first trimesteric abortion.

Patients and methods

The present study is a randomized controlled trial comparing first-trimester surgical evacuation of pregnancy with or without continuous ultrasound guidance. The present study was conducted in Police Authority Hospital and Kasr Al Ainy Hospital from 2010 to 2012. Written consent was obtained from all patients participating in the study.

Patients were randomly allocated into two groups: group I included 100 women to have the surgical evacuation under continuous real-time ultrasound guidance; group II included 100 women in whom surgical evacuation was performed without ultrasound guidance.

We included women undergoing surgical evacuation in their first trimester of pregnancy with no medical problems. We excluded those with multiple gestations, vesicular mole, presence of uterine pathology such as fibroid, or congenital uterine malformation such as bicornuat uterus.

Procedure

Patients who agreed to participate in the study were subjected to history taking, clinical examination, and initial investigations. All patients had a preliminary ultrasound to assess the size and axis of the uterus, the position and size of the pregnancy, and the type of miscarriage. The transducer was held on the abdomen to obtain a longitudinal image of the uterus, cervix and position of gestational sac, or any instrument passed into the uterus. The progress of the operation was continuously monitored as the uterine content was evacuated under visual supervision. The duration of the procedure was calculated to range from 15 to 25 min.

Data collection

Data collected about patients included their age, the number of fetuses, the number of pervious pregnancies and their outcomes, and gestational age. The primary outcomes were intraoperative hemorrhage, uterine perforation, and failed procedure; the retained products of conception cause infection, requiring repeated evacuation and infection.

The secondary outcomes were delayed bleeding and prolonged time of the procedure. Whether intraoperative scanning was considered satisfactory for visualization by the surgeon was also recorded.

Follow-up

Follow-up was performed 4–8 h after the procedure and before discharge for the primary outcome, with another delayed follow-up after 1 week with repeat ultrasound if needed.

Statistical analysis

Data were analyzed using the Statistical Package for the Social Sciences for Windows (version 9.0; SPSS Inc., Chicago, Illinois, USA). Comparison between the two groups was made using the χ2-test for categorical variables, the Mann–Whitney U-test for nonparametric variables, and independent sample t-test for parametric data, and the relative risk was calculated with 95% confidence intervals. All tests performed were two-sided, and the differences were considered statistically significant if the P-value was 0.05.

The study was approved by the institutional review board of the department of obstetrics & Gynecology, Faculty of Medicine.

Results

There was no significant difference between both groups regarding age, parity, gestational age, or the number of previous Caesarean section (CS). During follow-up, five cases treated without ultrasound guidance were noted to have evidence of infection in comparison with only two cases treated under ultrasound guidance (P=0.275). There was also a nonsignificant difference regarding hospital stay after evacuation (P=0.254).

However, there were significant differences between both groups in favor of performing the procedure under ultrasound guidance regarding incidence of complications such as perforation, intraoperative bleeding, and duration of the operation.

Discussion

Ultrasound evaluation of patients presenting with first-trimester bleeding is the mainstay of the examination; it is an important, helpful, and noninvasive tool in the investigation, diagnosis, and follow-up of such cases. In the present study, we tried it as a supplementary tool to surgical evacuation to avoid complications. Uterine perforation occurred only in four patients who did not have ultrasound guidance, which when compared with the absence of perforation with ultrasound guidance showed a P-value of 0.041. This means that ultrasound usage produced a significant result in reducing perforation during evacuation. Because of the easy accessibility to the cervix, sounding, dilatation and better visualization of the content of the uterus, safe removal of the content with no further curettage, or perforation is possible.

This matches well with a study conducted by other investigators including 11 747 cases between 1972 and 1981 in the USA and another case-series study in Canada between 1986 and 1990 including 547 cases treated by surgical evacuation at 12–14 weeks. They concluded that the incidence of uterine perforation was rare and that there were three factors affecting this complication: first personnel experience, second the use of ultrasound guidance during the procedure, and third the gestational age at the time of evacuation 4.

In the present study, nine cases suffered from intraoperative bleeding of more than 500 ml, with an incidence of 10% of the total number of the recruited cases treated without ultrasound compared with 1.1% of ultrasound-guided cases, showing a P-value of 0.009, which showed the statistical significance of ultrasound guidance in reducing intraoperative bleeding.

Ultrasound guidance shortened the duration of our procedure significantly as it helped decrease the duration of the procedure, being safer and easier to perform under supervision, and this was proved statistically by a P-value of 0.003. Prolonged operating time is one of the major factors that may lead to severe hemorrhage and hysterectomy. This was shown in a study conducted in the USA by Patel et al.5 in which six women had hemorrhage during the procedure, of which two required transfusion and one of the two affected cases required hysterectomy, and this was found to correspond with our results that there was less hemorrhage upon usage of ultrasound guidance.

In contrast to our study, other investigators performed a comprehensive analysis of the use of preprocedure ultrasound for first-trimester and second-trimester abortion; this study included 750 citations, which were scrutinized by these two authors, and 25 full test papers were obtained and these texts were evaluated in detail by these two authors; they excluded systematic previous randomized controlled trails and reports of any comparative studies on the use of preoperative ultrasound and no use of ultrasound for either safety or efficacy outcomes; they concluded that there was no evidence on the effects of preprocedure ultrasound for the risk associated with second-trimester abortion with regard to either safety or efficacy despite the fact that ultrasound is widely used in some settings to estimate the gestational age and to detect pregnancy abnormalities 6.

Any implications for routine ultrasound may be greater for pregnancies beyond the first trimester where appropriate procedures for managing miscarriage change with increasing gestational age. The use of resources to research this issue is questionable as the use of ultrasound is unlikely to be a risk to women’s health. Therefore, the primary consideration by policy makers should be the routine use of ultrasound with the potential benefit of detection of uncommon factors that may complicate or influence the miscarriage process, and this was against our study, which disregarded and ignored the cost-effectiveness of ultrasound usage.

Postoperative infection has been one of the major problems after any operation, or even expectant management of first-trimester miscarriage; in our study, there were five cases who suffered from postprocedure infection. Curettage by itself can actually lead to infection in 0.1–4.7% of cases 7.

Our study showed a reduced risk of postoperative infection when the procedure was performed under ultrasound guidance; this was compared with a study conducted by Sotiriadis et al.8, who concluded that ultrasound-guided surgical management is significantly more likely to induce complete evacuation of the uterus than either medical management or surgical evacuation without ultrasound guidance, which was associated with much less intraoperative as well as postoperative bleeding; this coincides with the results of our study, in which seven women suffered from intraoperative or postoperative bleeding when treated without ultrasound guidance.

Other investigators studied all women retrospectively: those undergoing medical evacuation versus surgical evacuation without ultrasound versus ultrasound-guided evacuation, between January 1999 and 31 December 2001; they concluded that the routine use of transabdominal or transvaginal ultrasound during evacuation markedly reduced the time needed for intervention, which was found to match with the results of our study as shown in the study by Acharya and Morgan 9.

Conclusion

Surgical evacuation under ultrasound guidance is safer, assuring less complications. Further studies are needed to confirm our results (Table 1).

T1-8
Table 1:
A comparison of the occurrence of uterine perforation among ultrasound-guided cases and those without ultrasound guidance

Acknowledgements

Conflicts of interest

There are no conflicts of interest.

References

1. Torloni MR, Vedmedovska N, Merialdi M, Betrán AP, Allen T, González R, Platt LD.Safety of ultrasonography in pregnancy: WHO systematic review of the literature and meta-analysis.Ultrasound Obstet Gynecol2009;33:599–608.
2. Rolo LC, Nardozza LMM, Araujo E Jr, Nowak PM, Filho JB, Moron AF.Measurement of embryo volume at 710 weeks’ gestation by 3D-sonography.J Obstet Gynaecol (Lahore)2009;29:188–191.
3. Acharya G, Morgan H, Paramanantham L, Fernando R.A randomized controlled trial comparing surgical termination of pregnancy with and without continuous ultrasound guidance.Eur J Obstet Gynecol Reprod Biol2004;114:69–74.
4. Grossman D, Blanchard K, Blumenthal P.Complications after second trimester surgical and medical abortion.Reprod Health Matters2008;16Suppl173–182.
5. Patel A, Talmont E, Morfesis J, Pelta M, Gatter M, Momtaz MR, et al..Adequacy and safety of buccal misoprostol for cervical preparation prior to termination of second-trimester pregnancy.Contraception2006;73:420–430.
6. Caserta L, Labriola D, Torella M, Di Caterina B.The use of transvaginal ultrasound following voluntary interruption of pregnancy to reduce complications due to incomplete curettage.Minerva Ginecol2008;60:7–13.
7. Wijesinghe PS, Padumadasa GS, Palihawadana TS, Marleen FS.A trial of expectant management in incomplete miscarriage.Ceylon Med J2011;56:10–13.
8. Sotiriadis A, Makrydimas G, Papatheodorou S, Ioannidis JPA.Expectant, medical, or surgical management of first-trimester miscarriage: a meta-analysis [review].Obstet Gynecol2005;1055 I1104–1113.
9. Acharya G, Morgan H.First-trimester, three-dimensional transvaginal ultrasound volumetry in normal pregnancies and spontaneous miscarriages.Ultrasound Obstet Gynecol2002;19:575–579.
Keywords:

bleeding; randomized; surgical evacuation; ultrasound

© 2014 Lippincott Williams & Wilkins, Inc.