Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms After 12-18 Week Abortion or Pregnancy Loss: A Pilot and Randomized Controlled Trial
Maimonides Medical Center
Summary
The goal of this clinical trial is to learn whether cabergoline can prevent lactation and reduce breast symptoms in pregnant people aged 18 years or older undergoing abortion or pregnancy loss between 12 and 18 weeks of gestation. The main questions it aims to answer are: Does cabergoline decrease the proportion of participants who experience breast symptoms (including breast engorgement, milk leakage, tenderness, and need for pain relief) after abortion or pregnancy loss? Does cabergoline reduce the severity of breast symptoms and associated bother compared with placebo? Researchers will compare participants receiving cabergoline to those receiving placebo to determine whether cabergoline reduces the frequency and severity of breast symptoms following abortion or pregnancy loss. Participants will: Complete a baseline survey assessing breast symptoms prior to the abortion or pregnancy loss procedure Receive a single oral dose of either cabergoline (1 mg) or placebo approximately one hour after the procedure Complete follow-up surveys on days 2, 3, 4, 7, and 14 after the procedure to assess breast symptoms and related bother A subset of participants will provide blood samples at selected time points to measure serum prolactin levels
Description
Breast symptoms such as breast engorgement, milk leakage, and tenderness are common after abortion or pregnancy loss in the second trimester because lactation can begin as early as 12-20 weeks of gestation. While care following abortion or pregnancy loss often focuses on pelvic symptoms, breast symptoms may also cause significant physical discomfort and emotional distress for patients. Prior research suggests that a large proportion of patients undergoing abortion or pregnancy loss between 14 and 20 weeks experience breast tenderness, engorgement, or milk production. However, the frequency and…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Pregnant people aged 18 years or older * Gestational age between 12 and 18 weeks * Undergoing treatment for spontaneous or induced abortion at Maimonides Medical Center * Able to provide informed consent * Willing and able to complete study surveys Exclusion Criteria: * Prior mastectomy * Currently breastfeeding * Current use of a dopamine agonist or dopamine antagonist medication * Known contraindication to Cabergoline according to the medication prescribing information
Interventions
- DrugCabergoline
Participants will receive a single oral dose of 1 mg of Cabergoline administered approximately one hour after completion of the abortion or pregnancy loss procedure. Cabergoline is a dopamine agonist that suppresses prolactin secretion and is used in this study to inhibit lactation and reduce breast symptoms.
- DrugPlacebo
Participants will receive a single oral dose of a placebo tablet administered approximately one hour after completion of the abortion or pregnancy loss procedure. The placebo will be identical in appearance to the cabergoline tablet and contains no active medication
Location
- Maimonides Medical CenterBrooklyn, New York