Use of erythromycin for nonsurgical female sterilization in West Bengal, India: a study of 790 cases

Abstract

Objective Determine if erythromycin is an effective agent for achieving occlusion of the Fallopian tube for nonsurgical female sterilization. Methods Two studies of 100 healthy volunteers requesting sterilization were planned, one in Julpia Andhermanik and the other in Kolkata (Calcutta). A readily available marketed tablet preparation containing 500 mg of the estolate salt of erythromycin was used for the trial. In one study (Bishnupur), the tablet was crushed before placing in a copper-T IUD inserter for placement at the fundus. In the other study (Kolkata), crushed tablets were processed into 50 mg pellets of the same diameter as standard quinacrine pellets and 10 pellets were inserted at the fundus using aseptic precautions. Procedures in each study were repeated at 30 days. Oral contraceptives were prescribed for three cycles following first insertion. No incentive was offered for participation in the trial. Follow-up treatment, including first-trimester abortion for pregnancy due to failure of the sterilization procedure, was assured without charge. Due to extraordinary patient demand, one study (Bishnupur) was expanded to 690 cases for reasons of compassion. Results At 12 months of use, the failure rate of the sterilization procedure for the crushed 500 mg tablets was 35.8% (SE = 1.8) with 417 women at risk. At 12 months of use, the failure rate for the erythromycin pellets was 28.6% (SE = 5.0) with 43 women at risk. There were no serious complications reported in either trial. All pregnancies resulting from failure of the sterilization procedure were terminated by menstrual regulation within 10 weeks gestation. Conclusions The failure rate in this study is unacceptably high for erythromycin to be used as a sterilization method.