Markenzie Jean-baptiste

OBGYN Clinical Online Case

Date: 5/16/2020

Title: Mifepristone Pretreatment for the Medical Management of Early Pregnancy Loss

Authors: Courtney A. Schreiber, M.D., M.P.H., Mitchell D. Creinin, M.D., Jessica Atrio, M.D., Sarita Sonalkar, M.D., M.P.H., Sarah J. Ratcliffe, Ph.D., and Kurt T. Barnhart, M.D., M.S.C.E

Journal: New England Journal Of Medicine, published 2018, currently indexed for MEDLINE.

Summary

This study was a randomized control trial that compared the efficacy and safety of pretreatment with mifepristone followed by treatment with misoprostol, with that of misoprostol alone in the medical management of first trimester pregnancy loss. Studies have shown that medical management with misoprostol alone has commonly resulted in treatment failure. The standard dose of 800 μg of misoprostol, administered vaginally, has shown to have low efficacy among women with a closed cervical os. Also, as many as 15 to 40% of such women require a second dose of misoprostol, which prolongs the treatment period. This is an important topic because first trimester miscarriage is the most common complication in pregnancy and affects approximately 1 million women in the United States annually. Also, medical management of early pregnancy loss allows for planned and expedited expulsion of nonviable pregnancy tissue, can help to relieve the burden accompanying early pregnancy loss and can avoid a surgical procedure like dilation and curettage.

The women that were included in this study were healthy, 18 years of age or older and had an ultrasound examination that showed a nonviable intrauterine pregnancy between 5 and 12 completed weeks of gestation. 300 women were randomly assigned to receive pretreatment with 200 mg of mifepristone, administered orally, followed by 800 μg of misoprostol, administered vaginally approximately 24 hours later (mifepristone-pretreatment group, n=148), or standard therapy with 800 μg of misoprostol alone, administered vaginally (misoprostol-alone group, n=149), on trial day 1. The participants returned 1-4 days after misoprostol use for examination which included ultrasound examination. For women in which the gestational sac was not expelled, they were offered expectant management, a second dose of misoprostol or uterine aspiration. The main outcome was gestational sac expulsion with one dose of misoprostol by the first follow up visit and no additional intervention needed within 30 days after the treatment.

The results of the study showed complete expulsion after one dose of misoprostol in 124 of 148 women (83.8%; 95% confidence interval [CI], 76.8 to 89.3) in the mifepristone-pretreatment group. In the misoprostol-alone group,  100 of 149 women had complete expulsion after one dose of misoprostol (67.1%; 95% CI, 59.0 to 74.6).  Also, uterine aspiration was performed less frequently in the mifepristone-pretreatment group than in the misoprostol-alone group (8.8% vs. 23.5%; relative risk, 0.37; 95% CI, 0.21 to 0.68). There was however more bleeding that resulted in blood transfusion in 2.0% of the women in mifepristone-pretreatment group compared to 0.7% in the misoprostol-alone group (P = 0.31). Both groups had 1.3 % of pelvic infections.  The author concluded that pretreatment with mifepristone followed by treatment with misoprostol resulted in a higher likelihood of successful management of first-trimester pregnancy loss than treatment with misoprostol alone. The study did not present with any limitations, but I think future studies can include a larger sample size to further strengthen the results of the study.

 

 

Source:

Schreiber, C., Creinin, M., Atrio, J., Sonalkar, S., Ratcliffe, S., & Barnhart, K. (2018). Mifepristone Pretreatment for the Medical Management of Early Pregnancy Loss. New England Journal Of Medicine, 378(23), 2161-2170. doi: 10.1056/nejmoa1715726

https://www-ncbi-nlm-nih-gov.york.ezproxy.cuny.edu/pmc/articles/PMC6437668/