Phase 2
N=73
Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Loss
Lactation Suppressed
Bottom Line
View on ClinicalTrials.gov: NCT04701333 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Number of Participants Reporting Breast Pain — 10; 32 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 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Breast Pain |
10; 32 | — |
| SECONDARY Number of Participants Experiencing Side-effects |
5; 2; 12; 9; 7; 7 | — |
| SECONDARY Number of Participants Reporting Significant Bother From Breast Pain |
1; 11 | — |
| SECONDARY Serum Prolactin Level |
6.5; 18.0 | — |
| SECONDARY Number of Participants Reporting Significant Bother From Side-effects |
2; 6 | — |
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
Data sourced from ClinicalTrials.gov (NCT04701333). 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.