A randomised double blind trial comparing misoprostol or placebo in the management of early miscarriage

Abstract

Objectives To study if misoprostol 400 Ag, administered vaginally, increased the successful resolution of early miscarriage compared with placebo. Design Randomised, double blind placebo controlled study.Setting Sahlgrenska University Hospital, Göteborg, Sweden.Sample One hundred and twenty-six women seeking medical attention for early miscarriage.Method Women with a non-viable, first trimester miscarriage were randomised to vaginal administration of misoprostol 400 Ag or placebo. Main outcome measures Main outcome measure was the proportion of successful complete resolution of miscarriage. Secondary outcomes were incidence of infection, bleeding, gastrointestinal side effects, pain, use of analgesics and length of sick leave between groups. Results Sixty-four patients were randomised to misoprostol and 62 to placebo. Eighty-one percent in the misoprostol and 52% in the placebo group had a complete miscarriage within one week of the primary visit (RR 1.57; 95% CI 1.20-2.06). Patients in the misoprostol group reported more pain as assessed on a visual analogue scale (60.4 [31.0] vs 43.8 [37.1] mm; P < 0.007) and required analgesics more often (83% vs 61%, RR 1.35; 95% CI 1.08 -1.70). There were no significant differences in the occurrence of gastrointestinal side effects, infection, reduction in haemoglobin or sick leave between the groups. Conclusions Treatment with 400 Ag misoprostol administered vaginally increased the success rate of resolvement of uncomplicated early miscarriages compared with placebo. However, women who received misoprostol experienced more pain and required more analgesics than those who did not.

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] .…”

“…maximum sonographic anteroposterior diameter of the uterine cavity contents < 15 mm or ≤ 15 mm 23,27,29,35 . This definition has been questioned 24,[36][37][38][39] .…”

“…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)…”

Use of Misoprostol in the Management of Early Pregnancy Loss

“…Among the study population 73.5% used pain killer for relieving pain. Eighty three percent required analgesics in a study done by Blohm et al 16 Pain killer can be used for pain relief without affecting the success of the method.…”