A Phase 2 interventional study of Cabergoline 1 MG and Placebo in Lactation Suppressed, sponsored by Stanford University. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Stanford University · Phase 2, Interventional, and Prevention
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.
This study is a double-blinded, placebo-controlled, gestational-age stratified superiority trial of those undergoing abortion or intrauterine fetal demise between 16 and 20-weeks gestation at Stanford Health Care. Participants will be randomized to either cabergoline 1 mg or placebo the day of procedure. Participants will complete a survey to assess symptoms, using the validated Bristol Breast Symptoms Inventory, and side-effects at baseline and Day 2, 4, 7, and 14 after the procedure. The study plan is to recruit 72 subjects powered to detect a 45% decrease in those reporting breast symptoms compared to the control group.
This study has the potential to improve overall patient experience by validating the routine use of cabergoline for lactation inhibition in the early second-trimester after abortion or pregnancy loss.
33 studies on the registry are indexed under Fetal Death; 8 are open to participants now.
This study's enrollment of 69 is below the median of 95 across 14 interventional studies indexed under Fetal Death.
Browse Fetal Death studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
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Inclusion Criteria:
Exclusion Criteria:
18 Years Female No No
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator.
Drug: Cabergoline 1 MG
After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant will be administered a placebo pill orally with juice or water by the clinician or study investigator.
Drug: Placebo
Dopamine agonist
Also known as: Dosintex
Placebo
Number of Participants Reporting Breast Pain
Participants will assess their breast symptoms using the validated Bristol Breast Inventory survey to assess 4 domains of breast symptoms: tenderness, engorgement, leaking milk, pain relief. Participants who indicated symptoms in any of these areas met the criteria for this outcome.
Time frame: Day 4 after procedure
Number of Participants Experiencing Side-effects
Participants selected from previously documented side-effects from the dopaminergic class or entered as free-text. Participants may have reported more than one side-effect. The experience of dopaminergetic medication side effects may or may not be considered to be adverse events.
Time frame: Cumulative over 2 weeks
Number of Participants Reporting Significant Bother From Breast Pain
Assessed using a Facial Pain Score; scale range 0-6 (higher scores indicate greater pain), with significant bother \>=4
Time frame: Day 4 after procedure
Number of Participants Reporting Significant Bother From Side-effects
Assessed using a Facial Pain Score; scale range 0-6 (higher scores indicate greater pain), with significant bother \>=4
Time frame: Cumulative over 2 weeks
| Milestone | Cabergoline | Placebo |
|---|---|---|
| Started | 34 | 35 |
| Completed | 32 | 34 |
| Not completed | 2 | 1 |
Participants will assess their breast symptoms using the validated Bristol Breast Inventory survey to assess 4 domains of breast symptoms: tenderness, engorgement, leaking milk, pain relief. Participants who indicated symptoms in any of these areas met the criteria for this outcome.
| Participants | Cabergoline | Placebo |
|---|---|---|
| Number of Participants Reporting Breast Pain | 16 | 30 |
Participants selected from previously documented side-effects from the dopaminergic class or entered as free-text. Participants may have reported more than one side-effect. The experience of dopaminergetic medication side effects may or may not be considered to be adverse events.
| Participants | Cabergoline | Placebo |
|---|---|---|
| Number of Participants Experiencing Side-effects | 26 | 31 |
Assessed using a Facial Pain Score; scale range 0-6 (higher scores indicate greater pain), with significant bother \>=4
| Participants | Cabergoline | Placebo |
|---|---|---|
| Number of Participants Reporting Significant Bother From Breast Pain | 1 | 7 |
Assessed using a Facial Pain Score; scale range 0-6 (higher scores indicate greater pain), with significant bother \>=4
| Participants | Cabergoline | Placebo |
|---|---|---|
| Number of Participants Reporting Significant Bother From Side-effects | 1 | 1 |
Collected over 14 days following drug/placebo allocation. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cabergoline | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| Placebo | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
Intent-to-treat (ITT) analysis - participants that did not provide any additional surveys beyond date of enrollment were excluded
| Age, Categorical(Participants) | Cabergoline | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 32 | 34 | 66 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Cabergoline | Placebo | Total |
|---|---|---|---|
| Mean | 27.8 ± 7.9 | 28.6 ± 7.2 | 28.2 ± 7.5 |
| Sex: Female, Male(Participants) | Cabergoline | Placebo | Total |
|---|---|---|---|
| Female | 32 | 34 | 66 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cabergoline | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 3 | 3 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 4 | 6 |
| White | 7 | 18 | 25 |
| More than one race | 2 | 2 | 4 |
| Unknown or Not Reported | 18 | 6 | 24 |
| Region of Enrollment(Participants) | Cabergoline | Placebo | Total |
|---|---|---|---|
| United States | 32 | 34 | 66 |
| Prior breastfeeding experience(Participants) | Cabergoline | Placebo | Total |
|---|---|---|---|
| Count of participants | 11 | 17 | 28 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified data may be requested for meta-analysis inclusion
Supporting information: Study protocol
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cabergoline