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

4 years ago

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

P. Sladkevicius, A. Fernlund, L. Jokubkiene, L. Valentin

Objectives To compare vaginal misoprostol treatment with expectant management in early non-viable pregnancies with vaginal bleeding with regard to complete evacuation of the uterine cavity within 10 days. Methods Parallel randomized controlled, open label, trial conducted in Skåne university hospital, Sweden. Patients with anembryonic pregnancy or early fetal demise (crown-rump length <33mm) and vaginal bleeding were randomly allocated to either expectant management or single dose 800μg of misoprostol vaginally. Patients were evaluated clinically and by ultrasound until complete evacuation of the uterus (no gestational sac in the uterine cavity and maximum anterior-posterior diameter of the intra-cavitary contents <15 mm as measured by transvaginal ultrasound on a midsagittal view). Follow-up visits were planned at 10, 17, 24 and 31 days. Dilatation and evacuation (D&E) was recommended if miscarriage was not complete in 31 days, but was performed earlier on patient's request, or if there was excessive bleeding as judged clinically. Analysis is by intention to treat. Main outcome measure is number of patients with complete miscarriage without D&E <10 days. Clinical Trials NCT01033903. Results Ninety-four patients were randomized to misoprostol and 95 to expectant management. After exclusion of three patients and withdrawal of consent by two patients 184 patients (n=94, n=90) were included. Miscarriage was complete <10 days in 62/94 (66 %) of the patients in the misoprostol group and in 39/90 (43%) of those in the group managed expectantly (risk difference 23%, 95% confidence interval 8% to 37%). At 31 days the corresponding figures were 81/94 (86%) and 55/90 (61%) (risk difference 25%, 12% to 38%). Two patients from each group underwent emergency D&E because of excessive bleeding and one of these in each group received blood transfusion. The number of patients undergoing D&E on their own request was higher in the expectantly managed group, 15/90 (17%) versus 3/94 (3%) (risk difference14%, 4% to 23%) as was the number of patients making out of protocol visits, 50/90 (56%) versus 27/94(29%) (risk difference27%, 12% to 40%). More patients in the misoprostol group than in the expectantly managed group experienced pain, 91/91 (100%) versus 71/77 (92.2%) (risk difference 7.8%, 1.0% to 16.8%), and used painkillers, 85/91 (93%) versus 59/77 (77%) (risk difference 17%, 5% to 29%). No major side effects were reported in any group. Conclusions Misoprostol treatment is more effective than expectant management in early non-viable pregnancies in women with vaginal bleeding with regard to complete evacuation of the uterus. Both methods are safe but misoprostol treatment is associated with more pain than expectant management.

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1002/uog.18940