About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Prior mastectomy
Currently breastfeeding
Current use of a dopamine agonist or dopamine antagonist medication
Known contraindication to Cabergoline according to the medication prescribing information
Trial design
Parallel
Treatments tested in this trial
Cabergoline
DrugParticipants 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.
Placebo
DrugParticipants 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
Treatment groups
Trial outcomes
Primary outcomes
Proportion of Participants With Breast Symptoms 4 Days After Abortion or Pregnancy Loss
The proportion of participants reporting any breast symptoms, including breast engorgement, milk leakage, tenderness, or need for pain relief, assessed using the Bristol Breast Symptoms Inventory.
Secondary outcomes
Participant-Reported Bother/Satisfaction From Breast Symptoms & Serum Prolactin Levels
Participant-reported level of bother related to breast symptoms following abortion or pregnancy loss, assessed using survey responses. Participant satisfaction with breast symptom management following abortion or pregnancy loss, assessed through survey responses. Serum prolactin levels measured in a subset of participants to evaluate the physiologic effect of cabergoline on lactation-related hormone levels.
Sponsors and contacts
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Jefferson Drapkin
Lead sponsor
Maimonides Medical Center
Sponsor institution