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Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Loss

Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Loss

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04701333
Acronym
LISTA
Enrollment
73
Registered
2021-01-08
Start date
2021-04-01
Completion date
2023-03-01
Last updated
2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactation Suppressed

Keywords

abortion, intrauterine fetal demise, second-trimester, lactation, engorgement

Brief 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.

Detailed description

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. In a head-to-head trial, cabergoline was more effective with a better safety profile than bromocriptine and has thus emerged as preferred treatment for term lactation inhibition internationally. Despite the frequency of breast symptoms after second-trimester abortions, there are no current guidelines for this population. The investigators are conducting a double-blinded, placebo-controlled, superiority trial of participants undergoing abortion or experiencing intrauterine fetal demise between 18 and 28-weeks gestation at Stanford Health Care. Participants will be randomized to either cabergoline 1mg or placebo the day of procedure. Participants will complete the Bristol Breast Inventory, a survey to assess symptoms and side-effects at baseline and day 2, 3, 4, 7, and 14 after the procedure. The primary outcome is breast symptoms on Day 4 as reported on the Bristol Breast Inventory. Secondary outcomes include satisfaction, acceptability, and side-effects. Investigators hypothesize that cabergoline is superior to placebo for preventing breast engorgement after second-trimester abortion or loss. A sub-study of 6 participants will return for serum prolactin levels at baseline, days 4, 7, 14 after procedure.

Interventions

Dopamine agonist

DRUGPlacebo

Placebo

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
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 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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Reporting Breast PainDay 4 after procedureParticipants 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.

Secondary

MeasureTime frameDescription
Number of Participants Experiencing Side-effects2 weeksParticipants selected from previously documented side-effects from the dopaminergic class or free-text. Participants may have reported more than one side-effect.
Number of Participants Reporting Significant Bother From Breast PainDay 4 after procedureAssessed using a Facial Pain Score (scale range 0-6, significant bother \>=4)
Serum Prolactin LevelDay 4 after procedureA subset of participants returned blood tests to measure effectiveness of drug
Number of Participants Reporting Significant Bother From Side-effectsDay 4 after procedureAssessed using a Facial Pain Score (scale range 0-6, significant bother \>=4)

Countries

United States

Participant flow

Participants by arm

ArmCount
Cabergoline
After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator. Cabergoline 1 MG: Dopamine agonist
36
Placebo
After the completion of the surgical procedure or medical induction for the 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. Placebo: Placebo
37
Total73

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up37
Overall StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicCabergolinePlaceboTotal
Age, Continuous30.5 years
STANDARD_DEVIATION 5.4
31.6 years
STANDARD_DEVIATION 5.7
31.1 years
STANDARD_DEVIATION 5.6
Ethnicity (NIH/OMB)
Hispanic or Latino
12 Participants13 Participants25 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
24 Participants24 Participants48 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Gestational age at time of procedure148.9 days
STANDARD_DEVIATION 13.4
147.7 days
STANDARD_DEVIATION 12.8
148.3 days
STANDARD_DEVIATION 13
Indication
Fetal anomaly
20 Participants27 Participants47 Participants
Indication
Fetal demise
2 Participants1 Participants3 Participants
Indication
Maternal comorbidity
0 Participants1 Participants1 Participants
Indication
Undesired pregnancy
14 Participants8 Participants22 Participants
Nulliparous16 participants25 participants41 participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
14 Participants15 Participants29 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants2 Participants
Race (NIH/OMB)
More than one race
3 Participants0 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants5 Participants12 Participants
Race (NIH/OMB)
White
11 Participants15 Participants26 Participants
Sex/Gender, Customized
Non-binary
1 Participants0 Participants1 Participants
Sex/Gender, Customized
Woman
35 Participants37 Participants72 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 360 / 37
other
Total, other adverse events
0 / 360 / 37
serious
Total, serious adverse events
0 / 360 / 37

Outcome results

Primary

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

Population: Participants who returned survey data for this outcome are included in the analysis.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CabergolineNumber of Participants Reporting Breast Pain10 Participants
PlaceboNumber of Participants Reporting Breast Pain32 Participants
Secondary

Number of Participants Experiencing Side-effects

Participants selected from previously documented side-effects from the dopaminergic class or free-text. Participants may have reported more than one side-effect.

Time frame: 2 weeks

Population: Participants who returned survey data for this outcome are included in the analysis.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
CabergolineNumber of Participants Experiencing Side-effectsLower extremity edema4 Participants
CabergolineNumber of Participants Experiencing Side-effectsDizziness/ lightheadness7 Participants
CabergolineNumber of Participants Experiencing Side-effectsHot flashes2 Participants
CabergolineNumber of Participants Experiencing Side-effectsNausea/ vomiting5 Participants
CabergolineNumber of Participants Experiencing Side-effectsPalpitations1 Participants
CabergolineNumber of Participants Experiencing Side-effectsHeadache12 Participants
CabergolineNumber of Participants Experiencing Side-effectsAnxiety4 Participants
CabergolineNumber of Participants Experiencing Side-effectsAcid reflux3 Participants
CabergolineNumber of Participants Experiencing Side-effectsInsomnia8 Participants
CabergolineNumber of Participants Experiencing Side-effectsFatigue12 Participants
CabergolineNumber of Participants Experiencing Side-effectsVisual disturbance1 Participants
CabergolineNumber of Participants Experiencing Side-effectsConstipation14 Participants
PlaceboNumber of Participants Experiencing Side-effectsVisual disturbance2 Participants
PlaceboNumber of Participants Experiencing Side-effectsHeadache9 Participants
PlaceboNumber of Participants Experiencing Side-effectsDizziness/ lightheadness7 Participants
PlaceboNumber of Participants Experiencing Side-effectsAcid reflux2 Participants
PlaceboNumber of Participants Experiencing Side-effectsConstipation18 Participants
PlaceboNumber of Participants Experiencing Side-effectsFatigue11 Participants
PlaceboNumber of Participants Experiencing Side-effectsLower extremity edema4 Participants
PlaceboNumber of Participants Experiencing Side-effectsHot flashes9 Participants
PlaceboNumber of Participants Experiencing Side-effectsPalpitations1 Participants
PlaceboNumber of Participants Experiencing Side-effectsAnxiety3 Participants
PlaceboNumber of Participants Experiencing Side-effectsInsomnia11 Participants
PlaceboNumber of Participants Experiencing Side-effectsNausea/ vomiting2 Participants
Secondary

Number of Participants Reporting Significant Bother From Breast Pain

Assessed using a Facial Pain Score (scale range 0-6, significant bother \>=4)

Time frame: Day 4 after procedure

Population: Participants who returned survey data for this outcome are included in the analysis.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CabergolineNumber of Participants Reporting Significant Bother From Breast Pain1 Participants
PlaceboNumber of Participants Reporting Significant Bother From Breast Pain11 Participants
Secondary

Number of Participants Reporting Significant Bother From Side-effects

Assessed using a Facial Pain Score (scale range 0-6, significant bother \>=4)

Time frame: Day 4 after procedure

Population: Participants who returned survey data for this outcome are included in the analysis.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CabergolineNumber of Participants Reporting Significant Bother From Side-effects2 Participants
PlaceboNumber of Participants Reporting Significant Bother From Side-effects6 Participants
Secondary

Serum Prolactin Level

A subset of participants returned blood tests to measure effectiveness of drug

Time frame: Day 4 after procedure

Population: Participants who returned for serum blood draws

ArmMeasureValue (MEAN)Dispersion
CabergolineSerum Prolactin Level6.5 ng/mLStandard Deviation 2.2
PlaceboSerum Prolactin Level18.0 ng/mLStandard Deviation 5.9

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026