A randomised trial of surgical, medical and expectant management of first trimester spontaneous miscarriage. Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial). A randomized controlled trial comparing medical and expectant management of first trimester miscarriage. Management of miscarriage: a randomized controlled trial of expectant management versus surgical evacuation. Randomised trial comparing expectant with medical management for first trimester miscarriages. Medical vs. surgical evacuation of first-trimester spontaneous abortion. Randomised trial of expectant versus surgical management of spontaneous miscarriage. A randomized study comparing efficacy and patient satisfaction in medical or surgical treatment of miscarriage. The impact of using a partially randomised patient preference design when evaluating alternative managements for heavy menstrual bleeding.
Medical management and expectant care have been considered possible alternatives to surgical evacuation of the uterus for first trimester spontaneous miscarriage in recent years.
                To compare the effectiveness and safety of medical and expectant management with surgical management for first trimester incomplete or inevitable miscarriage.
                Forty women were recruited following diagnosis of incomplete or inevitable miscarriage, and randomised to surgical, medical or expectant care via an off-site, computerised enrollment system. The primary outcome was the effectiveness of medical (vaginal misoprostol) and expectant management relative to surgical evacuation, assessed at 10-14 days and 8 weeks post-recruitment. Infection, pain, bleeding, anxiety, depression, physical and emotional recovery were assessed also. Analysis was by intention-to-treat.
                Effectiveness at 8 weeks was lower for medical (80.0%) and expectant (78.6%) than for surgical management (100.0%). Two women in the medical group had confirmed infections. Bleeding lasted longer in the expectant group than in the surgical group. There were no significant differences in pain, physical recovery, anxiety or depression between the groups. 54.6%, 42.9% and 57.1% of the surgical, medical and expectant groups respectively would opt for the same treatment again.
                Expectant care appears to be sufficiently safe and effective to be offered as an option for women. Medical management might carry a higher risk of infection than surgical or expectant care. To ascertain whether a clinically important difference exists in the incidence of gynaecological infection between surgical management and expectant or medical management of miscarriage.
                Randomised controlled trial comparing medical and expectant management with surgical management of first trimester miscarriage.
                Early pregnancy assessment units of seven hospitals in the United Kingdom.
                Women of less than 13 weeks' gestation, with a diagnosis of early fetal demise or incomplete miscarriage.
                Expectant management (no specific intervention); medical management (vaginal dose of misoprostol preceded, for women with early fetal demise, by oral mifepristone 24-48 hours earlier); surgical management (surgical evacuation).
                Confirmed gynaecological infection at 14 days and eight weeks; need for unplanned admission or surgical intervention.
                1200 women were recruited: 399 to expectant management, 398 to medical management, and 403 to surgical management. No differences were found in the incidence of confirmed infection within 14 days between the expectant group (3%) and the surgical group (3%) (risk difference 0.2%, 95% confidence interval - 2.2% to 2.7%) or between the medical group (2%) and the surgical group (0.7%, - 1.6% to 3.1%). Compared with the surgical group, the number of unplanned hospital admissions was significantly higher in both the expectant group (risk difference - 41%, - 47% to - 36%) and the medical group (- 10%, - 15% to - 6%). Similarly, when compared with the surgical group, the number of women who had an unplanned surgical curettage was significantly higher in the expectant group (risk difference - 39%, - 44% to - 34%) and the medical group (- 30%, - 35% to - 25%).
                The incidence of gynaecological infection after surgical, expectant, and medical management of first trimester miscarriage is low (2-3%), and no evidence exists of a difference by the method of management. However, significantly more unplanned admissions and unplanned surgical curettage occurred after expectant management and medical management than after surgical management. TRIAL REGISTRATION NATIONAL RESEARCH REGISTER: N0467011677/N0467073587. We aimed to determine whether outpatient treatment of miscarriage with vaginal misoprostol is more effective than expectant management in reducing the need for surgical evacuation of retained products of conception (ERPC).
                Of 131 eligible women with first trimester miscarriage, 104 agreed to randomization to either 600 microg misoprostol or placebo intravaginally. They were assessed the following day and administered a second dose of their allocated treatment if miscarriage was not complete. Those not successful after two doses were seen on day 7, and, if miscarriage was not complete, an ERPC was performed.
                The success rate of medical management was 88.5% (46/52) compared with 44.2% (23/52) for expectant management. There was no significant difference in success rate (100 versus 85.7%) in women treated with an incomplete miscarriage. Women with early pregnancy failure had a success rate of 87% with misoprostol compared with 29% with expectant management [odds ratio (OR) 15.96; 95% confidence interval (CI) 5.26, 48.37]. The complete miscarriage rate was achieved quicker in the medical group than the expectant group by day 1 (32.7 versus 5.8%) and by day 2 (73.1 versus 13.5%) of treatment. There were no differences in side-effects, bleeding duration, analgesia use, pain score and satisfaction with treatment. Women in the expectant group made more outpatient visits (5.06 versus 4.44%; OR = -0.62, 95% CI -1.04, -0.19). More women in the medical group (90.4 versus 73.1%; OR 1.26, 95% CI 1.05, 1.50) would elect the same treatment in the future.
                Medical management using 600 microg misoprostol vaginally is more effective than expectant management of early pregnancy failure. Misoprostol did not increase the side-effect profile and patient acceptability was superior to expectant management. In many countries, surgical uterine evacuation is the standard treatment for women with a miscarriage, but expectant management has been advocated as an alternative. The choice between the two options cannot be based on published evidence alone, because randomized clinical trials are scarce while generalizability of findings to patients with a strong preference for either management options is unclear.
                In a randomized controlled trial, the complications and efficacy of either expectant or surgical management for miscarriages were compared, and the results in patients who refused randomization and were managed according to their own preference were studied. In total, 122 patients were randomized and 305 were managed according to their choice.
                No differences were found in the number of emergency curettages and complications between expectant and surgical management. Efficacy at 6 weeks was 30/64 (47%) in women allocated to expectant management, and 55/58 (95%) in women allocated to surgical evacuation. After 7 days, 37% of expectantly managed women had a spontaneous complete miscarriage. After 6 weeks, intention-to-treat analysis including cross-overs showed similar effectiveness (92% versus 100%). Results in the preference groups were comparable with those in the randomized groups.
                In our experience a waiting period of 7 days after diagnosis may prevent 37% of surgical procedures. To compare the efficacy of antiprogesterone (mifepristone) in combination with a synthetic prostaglandin E1 analogue (misoprostol) for outpatient treatment of miscarriages.
                One hundred and twenty-two women with first trimester miscarriages.
                The women were randomised to treatment with mifepristone 400 mg orally followed by a single oral dose of 400 microg misoprostol 48 hours later (n = 60) or expectant management (n = 62). Women were re-evaluated five days later. If retained intrauterine products of conception were found with an antero-posterior diameter above 15 mm on transvaginal ultrasound, surgical evacuation was performed.
                Eighty-two percent of the women randomised to pharmacological treatment and 76% of those randomised to expectant management had an empty uterine cavity after five days. Convalescence time was 1.8 days longer for women randomised to pharmacological treatment. Pain, bleeding, complications, and satisfaction with the treatment did not differ between the groups.
                Most cases of spontaneous incomplete miscarriage will become a complete miscarriage without intervention. This study shows that outpatient treatment with a combination of antiprogesterone and a prostaglandin E1 analogue did not increase the rate of complete miscarriage, compared with expectancy alone, by a clinical important degree. To determine whether management of incomplete first-trimester abortion with vaginal misoprostol in an under-resourced setting is a viable treatment option.
                A total of 94 women were randomized to 600 microg of misoprostol intravaginally or to surgical curettage. The women receiving misoprostol were administered a second dose if the abortion was incomplete; and if still not complete after a week, evacuation of retained products of conception was performed. All women had a follow-up visit 2 weeks following complete abortion.
                The overall success rate of medical management was 91.5%, with 15 of 47 successful cases after 1 dose of misoprostol; 8.5% of the 47 women required evacuation of retained products of conception after 1 week because of treatment failure. The success rate in the surgical arm was 100%. Patients in the medical arm had a longer duration of bleeding and a greater need for analgesia. There were no differences in hemoglobin levels, white blood cell count, adverse effects, pain score, and satisfaction with treatment at the follow-up visit. However, more women who received the medical treatment would recommend it or choose it in the future.
                Medical management using 600 microg of misoprostol in 2 doses is effective to treat incomplete first-trimester abortions in an under-resourced setting when there is no evidence of uterine sepsis. Thirty-five women with retained products of conception after spontaneous miscarriage were randomised to expectant (n = 19) or surgical (n = 16) management, respectively. Women were reviewed at one week, two weeks and six months. There were no significant differences in the number of days of pain, bleeding, sick leave or return to normal periods. Nine of twelve women from the expectant group and six of nine from the surgical group who attempted to conceive did so by six months. All 16 women were satisfied with conservative management. This study provides further reassurance when considering expectant management for spontaneous miscarriage both in the short and medium term. To compare the efficacy of the medical treatment to surgical uterine evacuation and patient satisfaction in each group.
                A randomized, controlled study.
                An outpatient clinic in the Department of Gynecology and Obstetrics in Oulu University Hospital, Oulu, Finland.
                Ninety-eight eligible women who had had miscarriages.
                Medical treatment of miscarriage (n = 49) with 200 mg of mifepristone and 0.8 mg of misoprostol 1-3 days after the event or surgical uterine evacuation (n = 49). Questionnaires to collect data of experienced pain and patient satisfaction.
                The complete abortion rate with the primary treatment (primary outcome) and the patient satisfaction (secondary outcome).
                The success rate was equal (100% in surgical and 90% in medical group). More infections were diagnosed in the surgical group. Surgically treated patients were more satisfied with the treatment (100% vs. 88%). Medical treatment was considered more painful and fewer patients (70% vs. 91%) would choose the medical method in the future.
                Medical treatment is an effective alternative to surgical treatment and increases the choice available to women. Surgical treatment is associated with more infections. More medically treated patients experienced pain and dissatisfaction. To identify the advantages and disadvantages of using a partially randomised patient preference design rather than a conventional randomised controlled design when evaluating alternative managements for heavy menstrual bleeding.
                Randomised controlled comparison of two clinical trial designs with subsequent follow up of the cohorts of women generated.
                Women attending a general gynaecology clinic for the first time because of heavy menstrual bleeding.
                Partially randomised patient preference clinical trial design and conventional randomised controlled design.
                Overall participation; participation in randomised clinical trial of medical management compared with transcervical surgical resection of the endometrium; prognostic characteristics (socio-demographic and Short Form 36) of clinical trial groups; outcomes (clinical and Short Form 36) of clinical trial groups.
                Overall, more women participated in the partially randomised patient preference design (130/135 vs 97/138; difference 27%, 95% CI 18% to 34%) but there was no difference in the numbers who agreed to be randomised (90/135 vs 97/138; difference-3%, 95% CI-15% to 7%). Women who chose medical management tended to have better general health, to be less restricted by their menstrual problems, with fewer having been previously treated by their general practitioner. Those who chose transcervical resection of the endometrium had all tried medical management and had higher bleeding scores. Follow up satisfactions and acceptability rates, and Short Form 36 scores were highest after transcervical resection of the endometrium, whether chosen or randomised. Acceptability and a desire to continue the same treatment was greater among those who chose medical management than those randomly allocated it.
                Use of the partially randomised patient preference design did not affect recruitment to the randomised controlled trial suggesting that a conventionally designed trial would not be biased by motivational factors in this context. Data from the preference groups informed the generalisability of the results but did tend to confirm conclusions that anyway reasonably followed from the randomised controlled trial. The extra resource implications of using the partially randomised patient preference design were significant reflecting the additional 40% who participated and the extra analyses entailed.
Expectant management led to a higher risk of incomplete miscarriage, need for unplanned (or additional) surgical emptying of the uterus, bleeding and need for transfusion. Risk of infection and psychological outcomes were similar for both groups. Costs were lower for expectant management. Given the lack of clear superiority of either approach, the woman's preference should be important in decision making. Pharmacological ('medical') management has added choices for women and their clinicians and has been examined in other reviews.