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Misoprostol Abortion: Ultrasonography versus Beta-hCG testing for verification of effectiveness.

Byline: Fariba Behnamfar Mehrdad Mahdian Fereshteh Rahimi and Mansoureh Samimi

Abstract

Background and Objective: Miscarriage is a common complication of early pregnancy with medical and psychological consequences. Dilation and Curettage are considered as two standard caring ways for early pregnancy failure. Alternatively misoprostol has been used as a single agent for termination of early pregnancy. Aim of the present study was to compare the usefulness of serum AY-hCG measurement and ultrasound examination to predict complete abortion after medical induction.

Methods: There were one hundred and thirty three patients experiencing missed abortion or blighted ovum. Ultrasound examination and serum AY-hCG test were performed before treatment and during follow- up in all these patients.

Results: Treatment was successful without any need for surgical intervention in 92.4% of the cases. Both methods could verify the complete abortion among all the patients at the end of the study (4th week). Kappa agreement coefficient for the two methods of diagnosis was 0.327 (P less than 0.5).

Conclusion: Based on our results AY- hCG is as effective as ultrasound in confirming a successful medically induced abortion in early pregnancy but it should be used as supplements to clinical assessments.

KEY WORDS: Medical abortion Misoprostol hCG Ultrasound Verification of expulsion.

INTRODUCTION

Early pregnancy failure includes 1520% of all pregnancies.1 Of the all recognized pregnancies

1520% end spontaneously in the first and second trimester.2 Miscarriage is a common complication of early pregnancy that can have both medical and psychological consequences like depression and anxiety.3 Incomplete abortions can be managed expectantly surgically and medically.4 Dilation and curettage have been used for managing early pregnancy failure for more than half a century for the sake of high-quality medical care. Expectant management also works well; however it is sometimes less desirable to women (and some providers) who may prefer immediate treatment.4

Medical abortion is an alternative treatment being used widely for 30 years. It may be less costly than surgical treatment and consequently due to its lower complications most patients prefer it.1

Misoprostol is a stable synthetic prostaglandin E1 analogue that has been used for the prevention of gastric ulcers induced by non-steroidal anti- inflammatory drugs. Since like other prostaglandins this agent increases uterine tone5 it has been used off-label for cervical priming or ripening in medical abortion induction of labor and prevention of postpartum hemorrhage. Researchers have reported the high efficacy and safety of misoprostol used as a single agent for the termination of early pregnancy failure. 200800 g of vaginal misoprostol is successful for the treatment of early pregnancy failure up to 6080%.6-10

Confirming a complete medical abortion at the follow-up visit is an important component of completing a medical abortion. Three methods can be employed to confirm a complete abortion: (1) sonogram examination documenting an empty uterus (2) finding a 50% decrease per day in serial serum hCG levels and (3) observing the products of conception during the in-office misoprostol visit.11 The use of ultrasound to determine the outcome of medical abortion and possible need for surgical intervention clearly requires knowledge of the ultrasound finding following medical abortion. In addition ultrasound at follow-up is sometimes difficult to interpret.12

Monitoring serial hCGs is a very reliable and safe alternative to sonogram. Measuring hCG is also reliable in detecting a persistent pregnancy or incomplete expulsion even in the case of extra uterine. Successful expulsions were consistent with a marked decline in hCG value at follow-up. Measuring hCG can easily be done in most places and might be more convenient for women as compared to an ultrasound examination.

Furthermore there is no need to have it performed in the institution that performed the medical abor- tion.2 Series of studies have compared reliability and safety of ultrasound and measurement of hCG to confirm complete abortion. Some studies have con- cluded that measurement of serial hCG is preferred than ultrasound.12 Some studies showed similar ef- ficacy13 and some emphasized on supplementation of these measures with clinical assessment.1415 The aim of the present study was to compare the useful- ness of serum AY-hCG measurement and ultrasound examination to predict completeness of abortion af- ter medical induction.

METHODS

One hundred and forty four women with diagnosis of missed abortion or blighted ovum [confirmed by vaginal ultrasound (Medison 8000 vaginal probe

7.5 MHz)] with a gestational age less than 12 weeks and a crown-rump length (CRL) of 10 mm and a positive AY-hCG test who were candidate of medical

abortion after obtaining approval from our institutional review board (IRB) and written consent were enrolled the study during 2010. Levels of AY-hCG

were measured by ELISA test using a commercial kit (Immunotech Beckman Counter Co Czech Republic). Exclusion criteria were fever (Tgreater than 38C) leu-

kocytosis thrombocytopenia sever uncontrollable bleeding anemia mole hydatiform and septic abortion. The patients received 800 mg of misoprostol

vaginally at the hospital. After 24 hours if bleeding had not started at that time or it was lower on the first day of menstruation a second dose of 800 g misoprostol was orally given.

In cases with expulsion of pregnancy products placenta was checked exactly by the physician. Women who remained undelivered by 24 hours

after the last dose (receiving totally 1600g) under-went surgical intervention and were excluded from the study. All the women with confirmed expul-

sion of pregnancy products in hospital and regardless of presence or absence of remained products combined contraceptive (LD) were immediately

administered orally per day up to 21 days. The first follow-up to assess the treatment outcome was performed on the day 15 after expulsion. The

ultrasound examination and AY-hCG testing were repeated at this time. In cases with negative or declined AY-hCG more than 80% and empty uterine in

ultrasound (no remained material or endometrial thicknessless than 15 mm141617) follow-up was terminated. If not the women were advised to continue using

contraceptive until the 4th week and then AY-hCG test and ultrasound were repeated.

Finally in cases with negative AY-hCG and with-out remained products in uterine or endometrial thickness less than 15 mm in ultrasound the treat-

ment was regarded as successful and the follow-up was completed. Otherwise the patient was referred for surgical treatment and excluded from the study.

The AY-hCG levels at follow-up are given as the percentage of the value before the treatment and are presented as mean and (S.D.). Measurements of

endometrial thickness are given in mm and presented as mean and (S.D). The Sample size was calculated (minimum 60 cases in each group) using the

method of non-inferiority calculation and based on a similar study15 in which ultrasonography had a verification of 89.7% successful medically induced abortion in early pregnancy considering confi-

Table-I: Comparing ultrasound and -hCG measurements to verify the effectiveness of the treatment.

###Diagnosis Method of Complete abortion###Ultrasound###Sum###Kappa Coefficient

###After 2 weeks (%)###After 4 weeks (%)###

###-hCG After 2 weeks (%)###79(98.75)###37(69.8)###116 (87.2)###0.327

###After 4 weeks (%)###1 (1.25)###16 (30.2)###17 (12.8)

###Sum###80 (100)###53 (100)###133 (100)

dence interval of 95% power of 90% and maximum acceptable difference of 0.2.

The data were analyzed using the Levene test and t-test. Agreement regarding the two variables (AY-hCG and ultrasound) was performed using the kappa coefficient. The level of statistical significance was set at P less than 0.05.

RESULTS

A total of 144 women were initially enrolled in the trial (age range=15-45 years) but 11 cases withdrew from the study due to surgical intervention. Rest of the patients (133 cases) completed the treatment and returned for follow-up. Women's characteris- tics such as maternal age gravidity parity preg- nancy duration prior to abortion and body mass index were similar in the two groups. Of the 133 remained women the most ultrasound finding be- fore treatment was gestational sac (41.7%) and ges- tational sac with yolk sac (28.5%). There was a sig- nificantly higher rate of complete abortion (56.3%) among the women who received the second dose of misoprostol (1600 mcg) comparing with those re- ceiving 800 mcg of the drug (43.7%) (P less than 0.05).

The treatment was successful without any need for surgical intervention in 92.4% of the cases. Among the 133 cases 116 cases (87.2%) based on AY-hCG and 80 cases (60.15%) based on ultrasound were diagnosed with complete abortion in the second week of treatment. In addition of the 80 cases 79 (98.75%) were also diagnosed by AY-hCG while of the 116 cases 79 (68.1%) were diagnosed by ultrasound as well. Kappa agreement coefficient for the two methods of diagnoses was 0.327 (P less than 0.5). Both methods could verify complete abortion in all the patients at the end of the study (4th week) (Table-I). AY-hCG was more successful

than ultrasound for the diagnosis of complete abortion at the second week in cases that have had pain as a symptom (Table-II). Of the 11 cases that were excluded from the study two patients were hospitalized due to heavy bleeding. Both of them required surgical intervention after uncontrolled bleeding and the 8 remained cases did not expel products of conception after 24 hours of second dose of misoprostol and underwent surgical evacuation.

DISCUSSION

The results of this study showed that administrating misoprostol at a dose of 800 to 1600 mcg vaginally is an effective non-surgical method of treatment for evacuation of the uterus after abortion and measuring serum AY-hCG is as effective as ultrasound to confirm a successful medically induced abortion in early pregnancy.

In the present study the success rate after using vaginal misoprostol was 92.4%. Ngoc et al. (2004) found 92.9% success rate after administration of

800 mcg misoprostol.2 Fiala et al. (2003) reported a 98.2% success rate in their study using mifeprostone 600 mg and misoprostol 400 mcg orally followed 3

hours later by a second dose of 400 mcg misoprostol if the woman had not started to bleed.12 Behrashi and Mahdian (2008) have shown the 86.7% success

rate for vaginal misoprostol to second trimester pregnancy termination using it up to 1200 mcg.18 Our finding is in agreement with Ngoc's findings.

Slightly higher effectiveness in Fiala's study may be due to difference in the used drugs and/ or different methods of administration. Synergistic

effect of mifeprostone with misoprostol may be another reason. Using different dosages in the present study compared to Behrashi's report (1600 vs 1200mcg) may be the reason of higher success

Table-II: Comparing post-induction ultrasound and -hCG measurements to verify the

###effectiveness of the treatment based on history of pain.

###Variables###With Pain###Without Pain

###-hCG (%)###Ultrasound###-hCG (%)###Ultrasound

###Diagnosis at 2nd week###24 (96)###21 (84)###92 (85.2)###59 (54.6)

###Diagnosis at 4th week###1(4)###4 (16)###16 (14.8)###49 (54.4)

###Sum###25 (100)###25 (100)###108(100)###108 (100)

rate in our study. In the present study AY-hCG measurement could verify complete abortion during the second week in 87.2% of the cases however ultrasound could confirm it in 60.5% of the women. In Fiala's study these values at the second week for AY-hCG and ultrasound were 98.5% and

89.8% respectively.12 There is a similarity between our findings and Fiala's reports regarding AY-hCG measurements but differences in the results of ultrasound examination may be due to ultrasound devices dissimilarity (may be older devices with less sensitivity in our center) and sonographer skills leading to wrong diagnoses.

Clark et al. conducted a study to determine the safety and efficacy of providing medication abortion in a primary care site without routine use of pre- and post-procedure transvaginal sonography. In their study all the patients were intended to be followed up with serum hCG testing pre- and post-treatment. They used sonography only as needed for specific indications such as no successful medical abortion no hCG decline by at least 80% or in cases with uncertain history. They concluded using clinical protocol based on obtaining pre- and post-treatment serum hCG measurement with sonograms only when indicated had similar outcome to a protocol that used mandatory pre- and post-sonograms.13

El-baradie et al. (2008) showed that measurement of serum AY- hCG and ultrasound are clinically use- ful measures for predicting late failure of medi- cal abortion but should be used as supplements to clinical measurements.14 Fielding et al. (2002) based on their study concluded that if clinicians monitor hCG levels to identify any ectopic or con- tinuing pregnancies medical abortion can be safely performed without sonography.11 Although it is expected that bleeding may continue for too long with medical abortion17 the duration of bleeding in the present study was 2.6 days (SD=2.1) and mostly with spotting. Short bleeding may be due to use of OCP by the patients in our study.

In conclusion based on our results measuring AY- hCG is as effective as ultrasound to confirm a successful medically induced abortion in early pregnancy but should be used as supplements to clinical assessments.

ACKNOWLEDGMENTS

This study was part of the thesis of Dr. Fereshteh Rahimi supported by Deputy of Research Kashan University of Medical Sciences (Grant no: 8941). The authors gratefully acknowledge Kashan University of Medical Sciences for its support.

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Publication:Pakistan Journal of Medical Sciences
Date:Dec 31, 2013
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