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Clinical Trial Summary

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. The investigator's prior work demonstrated that compared to placebo, a single dose of cabergoline was effective in preventing breast symptoms after abortion or loss 18-28 weeks. As lactogenesis starts as early as 16 weeks gestation, the investigators hope to determine the efficacy of cabergoline earlier in the second trimester,16-20 weeks.


Clinical Trial Description

This study is a double-blinded, placebo-controlled, gestational-age stratified superiority trial of those undergoing abortion or intrauterine fetal demise between 16 and 20-weeks gestation at Stanford Health Care. Participants will be randomized to either cabergoline 1 mg 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, 4, 7, and 14 after the procedure. The study plan is to recruit 72 subjects powered to detect a 45% decrease in those reporting breast symptoms compared to the control group. This study has the potential to improve overall patient experience by validating the routine use of cabergoline for lactation inhibition in the early second-trimester after abortion or pregnancy loss. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06029673
Study type Interventional
Source Stanford University
Contact
Status Enrolling by invitation
Phase Phase 2
Start date February 7, 2024
Completion date December 2026

See also
  Status Clinical Trial Phase
Recruiting NCT03965572 - Factors and Outcomes Associated With Postpartum Cabergoline Use
Recruiting NCT04038749 - Satisfaction of Patients With the Chosen Method of Inhibition of Lactation N/A
Completed NCT05024422 - Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline N/A
Recruiting NCT06123026 - Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion Phase 4
Completed NCT04701333 - Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Loss Phase 2