CompletedPhase 2

Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss

United States69 participantsStarted 2024-02-07

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pregnant people, ages 18 years or older * Intrauterine pregnancy between 16/0-19/6 weeks of gestation age (by ultrasound dating performed prior to or same day of enrollment visit) * Consented for an induced, elective abortion or undergoing management of fetal 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: 18 Years Female No No 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 or antagonist therapy for other indication leg syndrome) * Contraindication to cabergoline (as per package insert) * Uncontrolled hypertension - defined as baseline BP \> 160/110, or chronic hypertension requiring more than one baseline medication, or current pregnancy-induced hypertension spectrum disorders (gesta…

What they're measuring

Number of Participants Reporting Breast Pain

Timeframe: Day 4 after procedure

Trial details

NCT IDNCT06029673

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-15

Results submitted2025-09-15