Abstract: Aim: Ectopic pregnancy can be treated either by surgical intervention or also by medical and expectant management if the patient is haemodynamically stable. The current study aims to determine the outcomes and safety of the combination of mifepristone and methotrexate in the medical management of ectopic pregnancy and evaluate the relation between the baseline serum progesterone and success rate(resolution) in the combination agent (study) group.
Materials and Methods: The study was an observational longitudinal follow up study of a cohort of women with ectopic pregnancy in the study period of February 2010 to November 2011 at Fernandez Hospital - Bogulkunta, a tertiary referral centre, in Hyderabad, AP.
40 women satisfying the inclusion criteria after due consent were registered into the study group of oral mifepristone plus systemic methotrexate. The patients with an ectopic pregnancy between January 2008 and December 2009, who met the same inclusion criteria for medical treatment and were treated with 50 mg/m2 methotrexate alone, were used as historical controls to compare outcomes.
Outcomes: A successful resolution of the ectopic pregnancy was achieved in 35 (85.36%) women who received the combination (cases) and 23 (69.6%) women who received only methotrexate (controls). Although clinically significant, this difference was not statistically significant (p=0.10). The median resolution time taken for ? HCG to fall to 10 MIu/ml in the combination group was significantly lower compared to the methotrexate group. All of the cases resolved within 6 weeks while 6 of the control took more than 6 weeks to resolve (p=0.001). The most common side effect seen in the combination group was the separation pain (65%) which subsided with nonopiate analgesics. The mean serum progesterone was 8 ng/ml and it ranged from 0.7 to 29.5 ng/ml. The mean time taken for normalization of ? hCG levels in women with serum progesterone > 10 ng/ml was 30.6 days versus 20.4 days in those with serum progesterone <10ng/ml.
Conclusion: Our prospective observational study has proved that the combination of methotrexate and mifepristone did better in terms of faster and cost effective resolution of ectopic pregnancy. Absence of any adverse effects related to the above combination appears to confirm the safety of mifepristone in combination of methotrexate. Serum progesterone was not helpful in predicting the success of medical treatment though ectopic pregnancy with higher progesterone levels required more days for resolution.