Effect of single-dose methotrexate injection to prevent neoplastic changes in high risk complete hydatidiform mole: A randomised control trial.

Abstract

Complete hydatidiform mole affects women in their reproductive age. About 15-20% develops persistent molar gestational trophoblastic neoplasia (GTN), which is linked with delayed (beyond 56 days) normalization of serum βHCG after surgical evacuation. The objective of the article is to shorten the duration of normalization time of βHCG with single-dose methotrexate injection in women with high risk complete hydatidiform mole (CHM) after suction evacuation. Total 76 women with CHM were randomized into intervention and control groups. In the intervention arm (n = 34) women received single dose 100 mg intramuscular methotrexate injection post evacuation and the control group (n = 42) had standard care. Surveillance was done in both groups at two weeks intervals for next six months and duration of normalization of βHCG level was recorded. Total 94.7% women completed follow-up. Mean of normalization time was significantly lower in the intervention group compared to controls (9.7 weeks versus 14.7 week; P < 0.01). Time to event curve showed significantly earlier cumulative normalization time for the intervention group. Single-dose 100 mg methotrexate injection is a low-cost, simple intervention to help one out of three women with CHM with high-risk features to achieve normalization of βHCG within 56 days. This might be helpful for people in resource-poor countries where adherence to prolonged surveillance is poor.