Misoprostol At 4 Weeks Pregnancy

In this prospective study, we found that medical termination of pregnancy using vaginal misoprostol alone was 96% effective in women with missed or incomplete intrauterine device expulsion, who were at risk for surgical evacuation.

In this prospective study, we found that medical termination of pregnancy using vaginal misoprostol alone was 96% effective in women with failed attempted first trimester surgical abortion and mifepristone/misoprostol regimens.

In this prospective study, we found that medical termination of pregnancy using vaginal misoprostol alone was 96% effective in women with limited fibroids. Although vaginal misoprostol alone resulted in a high success rate, the addition of mifepristone would improve the process further by reducing cramping.

In this prospective study, we found that medical termination of pregnancy using vaginal misoprostol alone was 96% effective in women with a gestation age of less than 6 weeks or 65 days after their last menstruation. Moreover, vaginal misoprostol alone was 100% effective in women who were more than six weeks pregnant but less than nine weeks pregnant.

The study objective is to evaluate the effectiveness and safety of medical termination of unwanted pregnancy in pregnant women who were 8 and more weeks of gestation by the single vaginal administration of 400 mcg misoprostol. In this prospective study, we found that medical termination of pregnancy using vaginal misoprostol alone was 96% effective in women with

Misoprostol at 5 Weeks Pregnancy

BACKGROUND: Misoprostol is a prostaglandin E1 analogue that has been used for medical abortion. We conducted this prospective study to compare the efficacy of vaginal misoprostol for abortion in women at a gestational age of <42 days and in women at a gestational age of 42–56 days. METHODS: A total of 160 women seeking medical termination of a pregnancy of <56 days were enrolled in the study. Medical termination was performed using 800 μg of vaginal misoprostol, repeated every 24 h for a maximum of three doses. RESULTS: The overall complete abortion rate was 91.3%. In group A (gestation <42 days) complete abortion occurred in 96.3% of women, whereas in group B (gestation = 42–56 days) complete abortion occurred in 86.3% of women (P < 0.025). The two groups did not differ significantly with respect to side-effects (incidence of pain, bleeding, nausea, diarrhoea, fever and headache). Women who had aborted successfully were significantly more satisfied with the method compared with women who did not (P < 0.001). CONCLUSIONS: The vaginal misoprostol-alone regimen is highly effective for women seeking medical abortion of pregnancies of ≤56 days. However, better efficacy may be achieved at a gestational age of <42 days.

abortionmisoprostolmedical pregnancy termination

Topic:

Issue Section:

 Fertility control

Introduction

Although surgical abortion is safe when done properly (Hakim-Elahi et al., 1990), some women choose medical abortion, especially those at a younger age or those who have not yet had their own family (Borgatta et al., 2001). The main advantage of medical abortion is that it allows women to avoid the risks of surgery and anaesthesia.

The first agent used for medical abortion was mifepristone (Couzinet et al., 1986), initially approved in France in 1988. Methotrexate was also employed in the early 1990s for medical termination of intrauterine pregnancies (Creinin, 1993).

Misoprostol is a prostaglandin E1 analogue that has been initially used for the treatment and prevention of gastric ulcer disease (Norman et al., 1991). In addition, misoprostol has been investigated as an agent to induce abortion (Barbosa and Arilha, 1993Coelho et al., 1993Costa and Vessey, 1993).

The administration of misoprostol along with either methotrexate or mifepristone regimens is highly effective for first trimester medical abortions; with efficacy rates ranging from 83 to 96% for methotrexate plus misoprostol (Creinin et al., 1996Wiebe, 1997Borgatta et al., 2001), to 92–97% for mifepristone plus misoprostol (Peyron et al., 1993Spitz et al., 1998Creinin et al., 2001). Misoprostol has also been used alone for medical abortions with variable efficacy (Carbonell et al., 1997199819992001Blanchard et al., 1999Jain et al., 1999).

We conducted this prospective study to compare the efficacy of vaginal misoprostol (up to three 800 μg doses) for abortion in women at a gestational age of <42 days and in women at a gestational age of 42–56 days.

Materials and methods

From January to December 2001, 160 women (age range 18–30 years, mean age 22.6 years) who requested medical termination of a pregnancy of ≤56 days were recruited for a prospective study that had been approved by the Ethics Committee of the University Hospital of Ioannina, Greece.

The inclusion criteria were: (i) age >18 years, (ii) a request for elective abortion, (iii) gestational age ≤56 days, as documented by vaginal ultrasonography (TVS) (Goldstein, 1991), (iv) haematocrit >30%, (v) adequate venous access, (vi) parity <3, (vii) a signed consent form, after participants had been informed about the possible risks and benefits of medical abortion with the understanding that there would be a surgical abortion if the medical abortion failed, and (viii) willingness to comply with schedule for visits and blood tests.

Women were excluded from the study if they had (i) known allergy to prostaglandins, (ii) symptoms indicating a threatened abortion, (iii) history of cardiac, respiratory, renal, hepatic or adrenal disease, (iv) history of thromboembolism, hypertension, coagulopathy and diabetes mellitus, (v) history or sonographic findings of uterine pathology, (vi) active pelvic infection, and (vii) prior elective abortion.

Gestational age was measured from the first day of the last menstrual period according to menstrual history and vaginal ultrasonography. A medical history was taken and a physical examination was performed. A baseline blood sample was obtained for complete blood count (CBC), rhesus status and β-hCG levels (AxSYM Total β-hCG, Microparticle Enzyme Immunoassay; non-pregnant values <3 IU/l).

Four clinic visits were scheduled. At visit 1 (day 1), the women received a vaginal administration of 800 μg misoprostol (Cytotec, Searle, USA), by digital insertion (four tablets of 200 μg misoprostol previously moistened with 2–3 drops of normal saline). The women remained recumbent for 15 min in the clinic prior to discharge. All participants were given prophylactic medication for possible side-effects (pain, nausea and vomiting), administered 30 min after the insertion of misoprostol: (i) 10 mg of metoclopramide (Primperan; up to 3 tablets/day if necessary) and (ii) a combination of 400 mg of paracetamol + 50 mg of caffeine + 10 mg of codeine phosphate (Lonarid N, Boehriger Ingelheim Hellas; up to 3 tablets/day, depending on pain intensity).

At visits 2 (day 2) and 3 (day 3), participants returned for a TVS examination and a CBC determination. During this period, the women were monitored for expulsion of the conceptus. If an intrauterine pregnancy was still present or the abortion was incomplete, an additional 800 μg misoprostol was administered vaginally along with the prophylactic medications. At visit 4 (day 4), the treatment outcome was assessed. Efficacy was defined as the termination of pregnancy with complete expulsion of the conceptus without the need for a surgical intervention. If the pregnancy continued or was incompletely aborted, the procedure was defined as failed and a surgical evacuation/curettage was scheduled within 1 week. In addition, surgical intervention was performed at any time if it was medically indicated or at a woman’s request (Winikoff et al., 1996). Women with Rh-negative blood received Rh(D) immunoglobulin within 72 h after the first application of misoprostol.

On the day of TVS confirmation of abortion, all women who successfully aborted (i.e., after the first, second or third dose of misoprostol) were given an additional 600 μg of vaginal misoprostol followed by 400 μg of oral misoprostol 24 h later.

The participants were asked to keep a symptom log of abdominal cramping, vaginal bleeding, nausea, vomiting, diarrhoea, headache and fever, and questioned at each visit for a detailed account of side-effects. Abdominal cramping was graded as follows: 0 = equal to menstruation; 1 = stronger than menstruation but tolerable; and 2 = much stronger, inhibiting normal activities. Vaginal bleeding was graded as follows: spotting, equal to menstrual flow, heavier than menstrual flow, and heavy enough to cause the patient anxiety.

Patient satisfaction was evaluated by questioning the women (i) on whether they would characterize the procedure as unsatisfactory, satisfactory or very satisfactory, (ii) about three of the advantages and three disadvantages of the procedure, and (iii) on whether they would choose this method again and/or recommend it to someone else.

Statistical analysis was performed using SPSS version 8 software. Pearson’s χ2-test and the likelihood ratio χ2-test were used to test the independence between the variables. Fisher’s exact test was used whenever there were cells with an expected frequency of <5%. All statistical tests were two-tailed and values of P < 0.05 were considered to indicate statistical significance.

Results

The characteristics of the 160 subjects are presented in Table I. All the subjects attended the repeated evaluations. Medical abortion rates differed significantly between the two groups (Table II). Overall, in group A (gestation <42 days) complete abortion occurred in 96.3% of women; whereas in group B (gestation = 42–56 days) complete abortion occurred in 86.3% of women (P < 0.025). Statistically significant differences in abortion rates were also observed after the 1st and 2nd dose of misoprostol: 71.3 and 92.5% in group A versus 51.3 and 80% in group B respectively. In group A, 51 women received one dose of misoprostol (63.8%), 23 women received two doses (28.7%) and six women received three doses (7.5%); whereas in group B, 25 women received one dose (31.3%), 39 women received two doses (48.7%) and 16 women received three doses (20%).

Suction curettage (i.e. failure of medical abortion) was arranged for three women in group A and 11 women in group B (P < 0.025). Medical abortion failure causes for each group are listed in Table III. The main indication for suction curettage was incomplete abortion.

The incidences of all reported side-effects are shown in Table IV. The two groups did not differ significantly with respect to side-effects (incidence of pain, bleeding, nausea, diarrhoea, fever and headache). In group B, four patients bled heavily; two women required blood transfusion and two women required emergency curettage.

Abdominal cramping was well-tolerated with the use of analgesia in the majority of the subjects. Only 13.1% of the women in both groups had difficulties carrying out normal activities due to abdominal cramping, and no hospital admissions were necessary (Table V). The other side-effects did not interfere with daily activities of any of the remaining subjects. Abdominal cramping and vaginal bleeding started 2.2 h (SD 0.72) and 4.1 h (SD 0.79) after misoprostol administration respectively. Total bleeding, including true bleeding and spotting, lasted 13.8 days (SD 3.7) in group A and 14.6 days (SD 4.3) in group B. No differences were found between the two groups regarding the onset of abdominal cramping or vaginal bleeding.

Overall, 91.3% of the women were satisfied with the method and would choose it again (Table VI). Women who had aborted successfully were significantly more satisfied with the method compared with women who did not (P < 0.001). Avoiding the risk of surgery and anaesthesia made the method attractive (80%); however, the duration of the protocol and the serial examinations remained a problem (70%).

Discussion

For first trimester medical abortions, misoprostol has been used extensively in conjunction with either mifepristone or methotrexate (Peyron et al., 1993Creinin et al., 1996Wiebe, 1997Spitz et al., 1998Borgatta et al., 2001Creinin et al., 2001). However, Greece is a country with no access to mifepristone, and the use of misoprostol alone is a reasonable strategy for medical abortion.

The main advantage of medical abortion is that it allows women to avoid the risks of surgery and anaesthesia. In this prospective study, we found that medical termination of pregnancy using vaginal misoprostol alone was 96% effective in women with gestational age of <42 days and 86% effective in women with gestational age of 42–56 days. Thus, these results indicate that, using vaginal misoprostol, better efficacy is achieved at a gestational age of <42 days. It has been reported that the efficacy of oral misoprostol decreases as pregnancy advances (Spitz et al., 1998). Nevertheless, in contrast to our findings, previous studies have shown that the efficacy of the vaginally administered misoprostol is not affected by the duration of pregnancy (El-Refaey et al., 1995; Jain et al., 1999,2001; Carbonel et al., 2001). The discrepancy in our findings may be primarily due to patient selection criteria: we excluded women with a history of prior elective abortion and parity of >3, because it has been reported that medical abortion success rates are decreased among women who had previous elective abortions (Spitz et al., 1998) and a parity history of >3 (Borgatta et al., 2001Creinin et al., 1996). In addition, we considered the need for surgical intervention 1 week after the 3rd misoprostol dose as representing failure, but abortion might have occurred later (World Health Organization Task Force on Post-ovulatory Methods of Fertility Regulation, 1993Anonymous, 1997Bugalho et al., 2000). Furthermore, a surgical termination performed at the woman’s request was classified as a failure.

The two groups did not differ significantly with respect to side-effects; however, in the later gestational age group, two women required blood transfusion, and two women required emergency curettage because of heavy bleeding. Although these complications are uncommon (Silvestre et al., 1990), the possibility of severe vaginal bleeding with medical abortion highlights the need for careful follow-up evaluation. Previous studies have indicated that ~1% of patients undergoing medical abortion will need emergency curettage because of heavy bleeding (Ashoc et al., 1998Schaff et al., 1999).

Although in our study misoprostol tablets were moistened before vaginal administration, it should be pointed out that randomized studies have shown that moistening the misoprostol tablets does not improve the efficacy of the regimen (Creinin et al., 1999Ngai et al., 2000).

Medical abortion should be offered to women who are willing to comply with all of the steps in the procedure (American College of Obstetricians and Gynecologists Practice Bulletin, 2001). In this study, all women returned for final confirmation of the outcomes of their pregnancies.

Disadvantages of medical pregnancy termination include the inconvenience of side-effects and the requirement of several medical visits. Abdominal cramping in medical abortion is unavoidable: almost all patients will experience some degree of pelvic cramping. In our study, only 13.1% of women reported severe abdominal cramping. However, the provided analgesia was efficient and no hospitalization was required due to excessive pain. Side-effects such as vomiting, nausea, headache, fever and diarrhoea were easily tolerated with regimens such as paracetamol and metoclopramide (Jain et al., 2001).

Overall, 91.3% of the women were satisfied with the method and would choose it again. Women who had aborted successfully were significantly more satisfied with the method compared with women who did not (P < 0.001).

In our study, no incidence of endometritis or pelvic inflammatory disease was observed. Indeed, in medical abortions the possibility of uterine infection is rare, with reported rates as low as 0.09–0.5% (Silvestre et al., 1990Spitz et al., 1998Schaff et al., 1999). In contrast, in surgical abortions infection rates range from 0.1 to 4.7% (Lichtenberg et al., 1999).

In conclusion, the vaginal misoprostol-alone regimen is highly effective for women seeking medical abortion of pregnancies of ≤56 days. However, in our study, better efficacy was achieved at a gestational age of <42 days. With advancing gestational age this regimen is less effective, whereas the incidence of side-effects may be higher.

Can Misoprostol Be Used Alone Without Mifepristone

Misoprostol and mifepristone have been shown to be effective for medical abortion up to 9 weeks of gestation. When used alone, the successful complete abortion rate dropped to ~60%. It has been demonstrated that by adding water to misoprostol, the success rate rose to 92%. This is the first randomized study to investigate the efficacy of misoprostol and water versus misoprostol alone for first trimester medical abortion in women at ≤ 9 weeks of gestation. Eighty women were randomly assigned to group 1 (water added to misoprostol) and group 2 (misoprostol alone). Vaginal misoprostol 800 μg was given on days 1, 3 and 5. If the woman did not require vacuum aspiration during the period up to the return of first menstruation after medical abortion, the outcome was classified as complete abortion. The incidence of side-effects and the acceptability were assessed through a standardized questionnaire during and after the abortion. The complete abortion rate appeared higher when water was added but the difference did not reach statistical significance. Gastro-intestinal side-effects were common but well tolerated in both groups. Overall, 40% of the women preferred a surgical method in the future because of the high failure rate. With an overall complete abortion rate of 85%, it is probably not a clinically acceptable method even if the addition of water can improve the results. We conclude that the addition of water onto misoprostol tablets does not improve its efficacy in first trimester medical abortion. Misoprostol alone is not recommended for medical abortion (up to 9 weeks of pregnancy) because of the high failure rate and low acceptability.

abortionmedicalmisoprostol

Topic:

Issue Section:

 Pregnancy and obstetrics

Introduction

Termination of pregnancy is one of the most common procedures in gynaecological practice. Vacuum aspiration has been used for first trimester termination of pregnancy. With the introduction of a cervical priming agent, the complications were significantly reduced. Although complications are uncommon, vacuum aspiration has been shown to be associated with uterine perforation, cervical injuries and excessive haemorrhage (Heisterberg et al., 1986). The overall complication rate varies between 4 and 10% (Farell et al., 1982). In the absence of complications, there is little evidence to suggest that surgical abortion has an adverse effect on future fertility.

Medical abortion had been available in Europe since 1990. Women can avoid the risks of surgery and anaesthesia. Mifepristone in combination with misoprostol is highly effective for first trimester medical abortion (Norman et al., 1991). Alternative regimens had been explored because mifepristone was not readily available in many countries. Methotrexate followed by misoprostol has also been shown to be effective (Creinin et al., 1995). However, side-effects related to methotrexate and the possibility of teratogenicity limit its popularity.

Misoprostol is a synthetic prostaglandin E1 analogue that was initially used for the treatment of gastric ulcer. We have shown that it is a safe and effective cervical priming agent prior to vacuum aspirations in first trimester abortion (Ngai et al., 19951996). It is also an effective abortifacient when given in repeated doses in second trimester abortion (Ho et al., 1997). The results of misoprostol alone in first trimester medical abortion were disappointing. The complete abortion rates were only 61–66% (Bugalho et al., 1996Koopersmith and Mishel, 1996). A 92% complete abortion rate in first trimester medical abortion (amenorrhoea <70 days) has been achieved simply by adding water to the misoprostol tablets prior to vaginal insertion (Carbonell et al., 1997). This was, however, the only published series that showed a satisfactory result. We decided to perform this prospective study to find out whether addition of water onto misoprostol tablets before insertion can improve the efficacy of misoprostol alone on first trimester medical abortion.

Materials and methods

Ethical approval for the study was granted by the Ethics Committee, Queen Mary Hospital. A total of 80 women requesting termination of pregnancy up to 9 weeks of gestation was recruited in our outpatient clinic and Family Planning Association of Hong Kong. All gave informed consent after the study had been explained, including their right to withdraw from the trial at any time without prejudice to their further medical care.

The subjects were between 16 and 42 years of age. All women satisfied the following criteria: (i) normal general and gynaecological examination; (ii) ≤9 weeks of gestation (as calculated from the date when the missed menstrual period should have started) on day 1 of the study; (iii) the size of the uterus on pelvic examination was compatible with the estimated duration of pregnancy. Exclusion criteria included: (i) history or evidence of disorders that represent a contraindication to the use of misoprostol (mitral stenosis, glaucoma, sickle cell anaemia, diastolic pressure >100 mm Hg, bronchial asthma); (ii) history or evidence of thrombo-embolism, severe or recurrent liver disease or pruritus of pregnancy; (iii) presence of intrauterine contraceptive device (IUCD) in utero; (iv) suspect or proven ectopic pregnancy; (v) heavy smoker (smoking >10 cigarettes daily in the past 2 years) or had another risk factor for cardiovascular disease.

Women were randomized into two groups: group 1, misoprostol with 3 drops of water per tablet (water group) and group 2, misoprostol only (no water group). On day 1, women in group 1 received vaginal misoprostol 800 μg with 3 drops of water added onto each tablet; women in group 2 received vaginal misoprostol 800 μg without water. They stayed in the day ward for a 4 h clinical observation period (hourly recordings of blood pressure and pulse rate). The time of misoprostol administration and expulsion of gestational products, if it occurred, were recorded on the data forms. They were assessed by one of the investigators at the end of the 4 h period. Women were asked to bring back the tissue mass if it was passed at home. They were advised to come back if excessive bleeding or abdominal pain was noted. On days 3 and 5, vaginal misoprostol (same treatment as that on day 1) was inserted and the observations were repeated. They were followed up again on days 15 and 43. Transvaginal ultrasound scan was performed in all women on day 15. Patients were examined and the bleeding patterns were checked on day 43. For those presenting with persistent bleeding or when menstruation had not returned, a further follow-up appointment was made.

The outcome of treatment was classified as: (i) complete abortion; (ii) incomplete abortion; (iii) missed abortion; and (iv) live pregnancy. The initial judgement about the outcome of therapy was made at the follow-up visit on day 15. If the ultrasound findings showed a live pregnancy (i.e. fetal heart activity present) on day 15, vacuum aspiration would be performed and the aspirates were sent for histological examination. If the ultrasound findings on day 15 were compatible with missed abortion (identifiable gestational sac without fetal heart activity), the investigator had the option of either termination of the pregnancy by vacuum aspiration or awaiting spontaneous expulsion of the products of conception. The choice between these two alternatives was left to the principal investigator after discussion with the subject. If the ultrasound findings were compatible with complete or incomplete abortion, no further action would be taken unless there was heavy bleeding or signs of pelvic infection. In these women the final judgement would be made on day 43. If no emergency or elective vacuum aspiration was necessary during the period up to the first menstruation, the outcome was classified as complete abortion. Tissues removed by vacuum aspiration were sent for histological confirmation.

Those who did not require vacuum aspiration were defined as successful cases. Failure was defined as the recourse to surgical abortion either due to method failure or change of patients’ decision. The incidence of side-effects, duration of vaginal bleeding, dosage of analgesic requirement and infection rate between the two groups were also compared. A standardized questionnaire was given to patients during and after the abortion in order to assess acceptability to the patients. The differences in the discontinuous variables were analysed by χ2 test or Fisher’s exact test. The differences of continuous variables were analysed by Student’s t-test for normally distributed data and the Mann–Whitney test for skewed data.

The calculation of sample error was based on the following assumptions: (i) type 1 error of 0.05 and power of 0.8 were acceptable; (ii) the `water group’ and `no water group’ would lead to complete abortion rates of 90 and 60% respectively. The sample size in each group should have been 38. Allowing for ~5% of the data not being available for use, the number in each group was 40. Therefore, the total sample size was 80.

Results

Patients’ characteristics are presented in Table I. A total of 73 women out of 80 completed the medical treatment. In all, seven women in group 2 dropped out of the study and underwent surgical treatment after two doses of misoprostol. No statistically significant differences were obtained when the demographic characteristics were compared between the two groups.

The incidence of side-effects is shown in Table II. No statistically significant differences were obtained for the frequency of any side-effects between the groups. All patients considered that the side-effects were tolerable, transient and decreased gradually after the first day of treatment. Nausea and vomiting were common but were well tolerated. About one-fifth of patients in both groups complained of breast tenderness and half of them complained of fatigue which was probably related to the pregnancy itself. Uterine cramps were the most common problem (75 and 57% in groups 1 and 2 respectively). The analgesia requirement was similar between the two groups (55.8 and 55.3% in groups 1 and 2 respectively). The majority of these patients needed a single dose of oral doloxene. The incidence and intensity of pain did not vary in relation to the treatment group or gestational age. The duration of bleeding was well accepted in all women. The pre- and post-treatment haemoglobin values were comparable between the two groups and there was no significant drop of haemoglobin after treatment. No patient suffered from excessive bleeding or required blood transfusion. The mean time for onset of bleeding was at 6.9 h in group 1 and 4.4 h in group 2.

The outcome of termination of pregnancy was shown in Table III. The rates of success were similar in the two groups. In group 1, treatment was successful for 34 of the 40 patients in group 1 who had water added [85%; 95% confidence interval (CI), 70–94%] and for 26 of the 40 patients in group 2 who had no water added (65%; 95% CI, 48–79%; not significant). In early pregnancy (≤7 weeks of gestation), the success rate in group 1 was 94.4% (95% CI, 72–99%) compared with 68.4% (95% CI, 43–87%; not significant) in group 2.

The cases in which failure occurred were classified (Winikoff, 1996) as follows: (i) method failure: group 1 (n = 6) and group 2 (n = 7) either live pregnancy or missed abortion on day 15 requiring vacuum aspiration, (ii) women’s own decision: group 2 (n = 7), changed their decision and opted for vacuum aspiration before completion of medical treatment, (iii) doctor’s decision. No women required transfusion or i.v. therapy and none of them had emergency surgery because of excessive pain or bleeding.

Seven women withdrew from the study. They all belonged to group 2, the no water group. Three of them withdrew on day 3 and four of them withdrew on day 5. All of them had suction evacuation with no complication.

The reasons for choosing medical abortion are listed in Table IV. It was noticed that worry about risks and complications of surgery was the major reason. Other factors that contributed to the decision making included the possible adverse effect on future pregnancy and the confidence about new medical technology.

Overall, 40% of the patients would prefer surgical treatment in the future; 60% in this group had experienced treatment failure. The reasons for choosing surgery if necessary, included inconvenience due to repeated visits (n = 15); high failure rate (n = 8); prolonged bleeding (n = 3); uncertainty about the success of medical treatment (n = 1) and pain (n = 1).

Discussion

A combination of the antiprogestin (mifepristone) and an exogenous prostaglandin given by i.m. injection or intravaginal pessary is a highly effective means of inducing abortion in early pregnancy (Rodger and Baird, 1987; World Health Organization, 1989). However, the search for a stable oral prostaglandin preparation has been largely unsuccessful. Misoprostol has greater advantages over other synthetic prostaglandin analogues. It is cheap and stable at room temperature. The drug is readily available. When 200–1000 μg of misoprostol was given 48 h after 200 μg oral mifepristone, complete abortion occurred in 95% of the women (Norman et al., 1991) with pregnancy <56 days. However, mifepristone is only available in four countries (France, UK, Sweden and China). This limits the widespread use of this regimen for first trimester medical abortion. Intramuscular or oral methotrexate, followed by misoprostol, has also been shown to be effective in first trimester medical abortion. The success rates range from 83 to 98% (Creinin et al., 19951996Hausknecht, 1995). However, the methotrexate-related side-effects and the potential teratogenicity in future pregnancy limit its popularity.

The efficacy of vaginal misoprostol alone for first trimester medical abortion varies widely, from 47 to 94% (Creinin et al., 1994; Carbonell et al., 1997). The latter group (Carbonell et al., 1997) used three doses of 800 μg every 48 h in women with pregnancy length <70 days. He modified the administrative procedure by adding 3 drops of water with misoprostol. The complete abortion rate in his study was 92%, which was comparable to that obtained from using mifepristone together with misoprostol (Normal et al., 1991). However, the size of the study was small and no control group was included. We therefore conducted a randomized trial to evaluate the use of misoprostol (with and without water) in medical abortion up to 9 weeks of gestation.

We showed that there was an apparent but not significant trend towards achieving higher complete abortion rate when water was added to misoprostol in medical abortion up to 9 weeks of pregnancy. However, this did not reach statistical significance and the difference was less than that estimated from previous results (Carbonell et al., 1997). With the overall complete abortion rate of 85%, it is probably not a clinically acceptable method even if the addition of water can improve the results. Moreover, the inconvenience of repeated administration of vaginal misoprostol compares unfavourably with the mifepristone–misoprostol regimen. However, the complete abortion rate with addition of water appears reasonable (94%) in pregnancies with menstrual delay of ≤7 weeks. Further studies may be worthwhile in this group of women.

All the women who withdrew from the study did so after the second dose of misoprostol. This was probably related to the relatively long treatment protocol. Patients became more anxious and the worry of treatment failure grew if they were not responding after `repeated medication’. From our results, we noted that ~70% in both groups passed the tissue mass after the second dose and a further 10% passed the tissue mass after the third dose. This information is useful in counselling in the future.

There is an increasing awareness among both the general public and the medical profession of the need to incorporate patients’ preferences into medical decision making. The acceptability of any method of treatment will influence the degree to which it is used by consumers, with important implications for health care planners (McNeil et al., 1982). Therefore, we included the patients’ views on acceptability in this study. A similar study had been performed in our department using RU486 and ONO802 in first trimester abortion (Tang et al., 1992). The reasons for patients choosing medical abortion in this study were very similar to those of the previous study. The worry about surgical complications remained the major concern prompting patients to choose a medical rather than a surgical method of abortion. The side-effects produced by misoprostol were minimal, transitory and comparable between the treatment groups. Pain was the most common physical symptom and was well tolerated. There was no difference in the incidence and intensity of pain between treatment groups. In the previous study (Tang et al., 1993), 80% of women would have chosen the same medical regimen again in future. In our study, we considered that the acceptability of the misoprostol regimen with or without water was low because 40% of women would not choose this regimen again. This was largely due to the high failure rate and inconvenience related to frequent visits. Overall, about one-fifth of the patients commented that the frequency of visits was higher than expected. Unacceptable side-effects, including prolonged bleeding and pain, also contributed to the preference for a surgical method in the future, if necessary.

We conclude that the use of misoprostol alone (either with or without water added) is not recommended for medical abortion up to 9 weeks of pregnancy because of the high failure rate and low acceptability by patients. Further study focusing on the medical abortion up to 7 weeks may be worthwhile.

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