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Completed

NCT Number: NCT06029673

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

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.

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Key information

Conditions

Lactation Suppressed Behavior Breast Feeding Cardiovascular Diseases Death Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Fetal Death Hyperemia Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Planned Parenthood - San Jose Central Health Center, San Jose, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cabergoline 1 MG

Drug

Dopamine agonist

Other names: Dosintex

Placebo

Drug

Placebo

Primary outcomes

  1. Number of Participants Reporting Breast Pain

    Time frame: Day 4 after procedure

    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.

Secondary outcomes

  1. Number of Participants Experiencing Side-effects

    Time frame: Cumulative over 2 weeks

    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.

  2. Number of Participants Reporting Significant Bother From Breast Pain

    Time frame: Day 4 after procedure

    Assessed using a Facial Pain Score; scale range 0-6 (higher scores indicate greater pain), with significant bother >=4

  3. Number of Participants Reporting Significant Bother From Side-effects

    Time frame: Cumulative over 2 weeks

    Assessed using a Facial Pain Score; scale range 0-6 (higher scores indicate greater pain), with significant bother >=4

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Planned Parenthood Mar Monte

Registry information

Official study title

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

Acronym: eLISTA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2023
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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