Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial)

Abstract

Objective To ascertain whether a clinically important difference exists in the incidence of gynaecological infection between surgical management and expectant or medical management of miscarriage. Design Randomised controlled trial comparing medical and expectant management with surgical management of first trimester miscarriage. Setting Early pregnancy assessment units of seven hospitals in the United Kingdom. Participants Women of less than 13 weeks' gestation, with a diagnosis of early fetal demise or incomplete miscarriage. Interventions 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). Main outcome measures Confirmed gynaecological infection at 14 days and eight weeks; need for unplanned admission or surgical intervention. Results 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%). Conclusions 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.

Misoprostol treatment vs expectant management in women with early non‐viable pregnancy and vaginal bleeding: a pragmatic randomized controlled trial

“…Our results confirm those of others, that misoprostol treatment shortens the time to complete miscarriage in women with a non-viable early pregnancy 18,19,23,25,27,31 (see Table 4), but they also show that expectant management is a viable alternative to medical treatment. Many women find expectant management highly attractive 24,34,40 .…”

“…In addition, in many trials, D&E was carried out after a very short period of observation, so that the chance of successful treatment with long observation cannot be evaluated properly. Results of published randomized trials comparing misoprostol treatment with expectant management or placebo are summarized in Table 4 18,19,23,25,[27][28][29][30][31] .…”

“…However, the number finally analyzed almost reached the number needed according to our sample size calculation. Difficulty with recruiting patients to randomized trials on management of early pregnancy failure is not unique to our study 25,30,32 . Our experience, in accordance with that of others, is that many patients have a strong preconceived treatment preference 32 .…”

“…D&E before first follow-up (n = 2) (Bleeding (n = 2)) D&E before first follow-up (n = Follow-up day 24 (22)(23)(24)(25)(26)(27)(28) (n = 34) Failed to appear (n = 2) Follow-up day 31 (30)(31)(32)(33)(34)(35)(36)(37) (n = 11)…”

“…Antibiotics were prescribed when an infection was suspected on the basis of symptoms, clinical findings and laboratory results as recommended by the US Centers for Disease Control and Prevention 22 . Sample size calculation was based on the assumption of a 70% success rate (complete miscarriage within 10 days after randomization) in the misoprostol group and 50% success rate in the expectantly managed group [23][24][25] . To achieve 80% power with an alpha error of 0.05 the total required sample size was 93 patients in each group.…”