Treatment of first trimester miscarriage: a prospective cohort study in a large tertiary care center in Northern Italy
Objective: To assess acceptability, efficacy, and short- and medium-term complications of vaginal misoprostol therapy for the treatment of first trimester miscarriage.
Study design: A prospective cohort study including women admitted to the Unit of Obstetrics, MBBM Foundation, San Gerardo Hospital (Monza, Italy) for medical or surgical treatment of first trimester miscarriage between October 2014 and March 2018. As per Institutional protocol, patients in the medical therapy group received 800 µg of misoprostol vaginally. A second dose could be considered 3 days after the first administration if that was ineffective. Surgical treatment consisted of uterine vacuum aspiration. Success of misoprostol treatment was defined as the expulsion of the gestational sac with no need for subsequent surgery.
Results: During the study period, 967 patients were diagnosed with first trimester miscarriage and were included in the study. Of these, 514 (53.2%) women were eligible for and consented to medical therapy. Surgical treatment was performed in the remaining 453 (46.8%) patients due to either medical contraindication to misoprostol or patient’s choice. Acceptance of misoprostol as first therapeutic choice increased over time, becoming the preferred treatment after approximately 18 months of use in clinical practice. One dose of misoprostol was successful in 69.8% (n = 359) of patients, whereas 20 women required urgent surgery for bleeding (n = 19) or suspected infection (n = 1). Among the remaining 135 patients, 20 (14.8%) refused the second dose of misoprostol and opted for surgery. Expulsion of the gestational sac was obtained in 74 additional cases who completed the medical protocol, for an overall success rate of 87.7% (433/494). The majority of women receiving misoprostol did not experience any short-term complication (92.0%) or side effect (93.8%). Eight (1.6%) cases requiring delayed surgery (hysteroscopy or vacuum aspiration) for retained product of conception were identified at the postmedical treatment follow up, thus leading to an actual success rate of misoprostol of 86.0% (n = 425).
Conclusions: This is the first study assessing the acceptability, efficacy, and complication rate of medical management of first trimester miscarriage in an Italian tertiary care center. Our results confirm that misoprostol alone is an effective as well as a safe therapeutic option for the treatment of first trimester miscarriage.