A pilot randomized controlled clinical trial of second uterine curettage versus usual care to determine the effect of re-curettage on patients' need for chemotherapy among women with low risk, nonmetastatic gestational trophoblastic neoplasm in Urmia, Iran.

ABSTRACT

OBJECTIVE: The objective of this study was to determine if second curettage was associated with a decreased need for the number of chemotherapy treatments compared to usual care. METHODS: A pilot randomized controlled clinical trial was designed at Motahhari Referral Hospital in 2014. Fifty-two patients with low risk, nonmetastatic gestational trophoblastic neoplasm were assigned randomly to two arms. The interventional arm included a repeat uterine curettage, and the control group received standard care (chemotherapy). All participants were followed periodically over 6 months. Primary outcome was defined as the number of chemotherapy courses in each arm. Student's t-test and receiver operator characteristics (ROC) curve were applied for statistical analysis as appropriate. RESULTS: Fifty percent of participants who underwent re-curettage did respond to intervention with no further chemotherapy after 6 months of follow-up. The intervention arm had higher number of remissions without chemotherapy compared to those who received usual care. In the subgroup analysis, the ROC curve could predict the re-curettage treatment response by beta human chorionic gonadotropin (BhCG) level significantly. No complications were reported in the intervention arm. CONCLUSION: Second curettage is an alternative effective procedure to decrease the need for chemotherapy among patients with low risk, nonmetastatic gestational trophoblastic neoplasm. Further clinical trials with larger sample size may be needed to determine the effective role of second curettage among patients.