Breast pain following second-trimester abortion is common. Breast engorgement and milk leakage following second-trimester perinatal loss and abortion can cause both physical pain and emotional distress. Dopamine agonists have previously been shown to be effective in lactation inhibition for third-trimester fetal/neonatal loss or contraindications to breastfeeding. In a head-to-head trial, cabergoline was more effective with a better safety profile than bromocriptine and has thus emerged as preferred treatment for term lactation inhibition internationally. Despite the frequency of breast symptoms after second-trimester abortions, there are no current guidelines for this population.
We will conduct a double-blinded, placebo-controlled, site-stratified superiority trial of those undergoing abortion or intrauterine fetal demise between 18 and 28-weeks gestation at Stanford Health Care or DuPont Clinic. Participants will be randomized to either cabergoline 1mg or placebo the day of procedure. Participants will complete a survey to assess symptoms, using the validated Bristol Breast Symptoms Inventory, and side-effects at baseline and Day 2, 3, 4, 7, and 14 after the procedure. Our primary outcome is breast symptoms on Day 4. Secondary outcomes include satisfaction, acceptability, and side-effects. We plan to recruit 100 subjects powered to detect a 30% decrease in those reporting breast symptoms compared to the control group. A sub-study of 10 participants will return for serum prolactin levels on Days 2, 4, 7, 14.
This study has the potential to improve overall patient experience by validating the routine use of cabergoline for lactation inhibition after second-trimester abortion or loss.