Phase 2 N=69 Randomized Quadruple-blind Prevention

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

Lactation Suppressed

Bottom Line

View on ClinicalTrials.gov: NCT06029673 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2025

Primary outcome: Primary: Number of Participants Reporting Breast Pain — 16; 30 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cabergoline 1 MG (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Stanford University
Primary completion: Jun 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Reporting Breast Pain	16; 30	—
SECONDARY Number of Participants Experiencing Side-effects	26; 31	—
SECONDARY Number of Participants Reporting Significant Bother From Breast Pain	1; 7	—
SECONDARY Number of Participants Reporting Significant Bother From Side-effects	1; 1	—

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.

Eligibility Criteria

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 (gestational hypertension, preeclampsia, eclampsia)
History of cardiac valvular disorders or valvular repair
History of pulmonary, pericardial, or retroperitoneal fibrotic disorders

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06029673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.