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

Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Lactation Suppressed
• Intervention / Treatment: Drug: Placebo; Drug: Cabergoline 1 MG

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States, 95126
      • Planned Parenthood - San Jose Central Health Center
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cabergoline; 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; Dopamine agonist; Other Names: Dosintex
Placebo Comparator: Placebo; 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; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 4 after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	Cumulative over 2 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Planned Parenthood Mar Monte

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2024
• Primary Completion (Actual): June 15, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: engorgement; lactation; abortion; fetal demise
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Death; Pathological Conditions, Signs and Symptoms; Behavior; Feeding Behavior; Fetal Death; Hyperemia; Breast Feeding; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Heterocyclic Compounds, 4 or More Rings; Ergot Alkaloids; Ergolines; Cabergoline
• Other Study ID Numbers: 71540

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data may be requested for meta-analysis inclusion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No