Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Loss
Condition: Lactation Suppressed
Intervention: Cabergoline 1 MG; Placebo
Intervention description: Dopamine agonist; Placebo
Intervention MeSH terms: Cabergoline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 73.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: abortion; intrauterine fetal demise; second-trimester; lactation; engorgement

Summary:

      This research study investigates the use of a drug, cabergoline, given immediately after
      second-trimester abortion or perinatal loss to decrease breast engorgement. Cabergoline is a
      medication approved for the symptomatic treatment of pituitary adenomas that result in a
      hyperprolactinemic state (a brain tumor that results in milk leakage). The benefit of
      stopping milk leakage has also been studied and used in populations who shouldn't breastfeed.
      The investigators aim to clarify if cabergoline is effective in preventing breast engorgement
      and milk leakage after second-trimester abortions or perinatal loss (stillbirth). Breast
      engorgement causes physical pain and emotional distress as lactation is uniquely associated
      with parenthood and those undergoing second-trimester abortions are doing so because they
      choose not to parent or a previously desired pregnancy is now complicated by anomalies. As
      there are no current recommendations for management of this painful engorgement beyond
      icepacks and support bras, the investigators aim to validate the use of this pharmacologic
      option in this setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant people, ages 18 years or older

          -  Intrauterine pregnancy between 18/0-28/0 weeks of gestation age (by ultrasound dating
             performed prior to or same day of enrollment visit)

          -  Consented for an induced, elective abortion or undergoing induction for demise

          -  English or Spanish speaking

          -  Able to consent for a research study, literate in English or Spanish

          -  Willing to comply with study procedures and follow-up

          -  Access to smart phone throughout study

        Exclusion Criteria:

          -  Prior mastectomy (breast reduction or chest masculinization surgery acceptable)

          -  Currently breastfeeding

          -  Currently receiving dopamine agonist therapy for other indication (prolactinoma,
             Cushings syndrome, acromegaly, restless leg syndrome)

          -  Contraindication to cabergoline (as per package insert)

               -  Uncontrolled hypertension - defined as baseline BP > 150/100, or chronic
                  hypertension requiring more than one baseline medication, or pregnancy-induced
                  hypertension spectrum disorders (gestational hypertension, preeclampsia,
                  eclampsia)

               -  History of cardiac valvular disorders or valvular repair

               -  History of pulmonary, pericardial, or retroperitoneal fibrotic disorders