Erythromycin Gel Dosing Study Pilot Survey

Sponsor

Family Health International

Principal Investigator

Dr. Gretchen Stuart, Obstetrics and Gynecology

Project Run Dates

2/1/2007 to 12/31/2007

Total Award Amount

$4,107

 

Summary

Investigators at Family Health International (FHI) are exploring the development of a nonsurgical female sterilization method involving the transcervical uterine delivery of a gel containing erythromycin, a sclerosing agent, to cause tubal occlusion. If effective, the procedure would offer a safer, less costly alternative to surgical sterilization and would be particularly welcome in resource-limited settings. FHI is planning a four-stage clinical project to develop and evaluate this nonsurgical sterilization technique with erythromycin gel. To inform the selection of research sites for this future study, FHI wishes to assess the feasibility of recruitment at potential clinical centers. The plan for this assessment is to conduct a survey of women who meet eligibility criteria and are planning a tubal ligation. Women will be recruited from 1.) the UNC-CH Family Planning Clinic when they present for a sterilization consult where the interview will take place before or after their scheduled clinic appointment and; 2.) from the surgery schedule to identify women scheduled for a tubal ligation. These women will be contacted by telephone to determine interest and willingness to participate, and a convenient in-hospital meeting time (at the pre-op visit or right before surgery) will be determined. The trained project manager will intercept and interview women presenting for care at the hospital or clinic and request oral consent to ask a series of questions that will take approximately 30 minutes to answer. The purpose of this pilot exercise is to estimate the potential enrollment rate at UNC-CH, to evaluate the informed consent process, and to determine appropriate participant compensation.

 

Associated Publications and other materials

 

Associated Award Numbers: A07-0987-001

Associated Sponsor Award Numbers: 00-92948-05298