Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms

Official title

Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms After 12-18 Week Abortion or Pregnancy Loss: A Pilot and Randomized Controlled Trial

Overview

The goal of this clinical trial is to learn whether cabergoline can prevent lactation and reduce breast symptoms in pregnant people aged 18 years or older undergoing abortion or pregnancy loss between 12 and 18 weeks of gestation. The main questions it aims to answer are: Does cabergoline decrease the proportion of participants who experience breast symptoms (including breast engorgement, milk leakage, tenderness, and need for pain relief) after abortion or pregnancy loss? Does cabergoline reduce the severity of breast symptoms and associated bother compared with placebo? Researchers will compare participants receiving cabergoline to those receiving placebo to determine whether cabergoline reduces the frequency and severity of breast symptoms following abortion or pregnancy loss. Participants will: Complete a baseline survey assessing breast symptoms prior to the abortion or pregnancy loss procedure Receive a single oral dose of either cabergoline (1 mg) or placebo approximately one hour after the procedure Complete follow-up surveys on days 2, 3, 4, 7, and 14 after the procedure to assess breast symptoms and related bother A subset of participants will provide blood samples at selected time points to measure serum prolactin levels

Detailed description

Breast symptoms such as breast engorgement, milk leakage, and tenderness are common after abortion or pregnancy loss in the second trimester because lactation can begin as early as 12-20 weeks of gestation. While care following abortion or pregnancy loss often focuses on pelvic symptoms, breast symptoms may also cause significant physical discomfort and emotional distress for patients. Prior research suggests that a large proportion of patients undergoing abortion or pregnancy loss between 14 and 20 weeks experience breast tenderness, engorgement, or milk production. However, the frequency and severity of these symptoms earlier in the second trimester (12-18 weeks) has not been well characterized.

Historically, medications such as bromocriptine were used to suppress lactation following pregnancy termination or delivery. However, bromocriptine has been associated with serious cardiovascular, neurologic, and psychiatric side effects and is no longer recommended for lactation suppression in the United States. Cabergoline, a dopamine agonist that suppresses prolactin secretion, has emerged as a safer alternative and has been shown to be effective in suppressing lactation after full-term delivery. More recent studies suggest that cabergoline may also reduce breast symptoms following abortion or pregnancy loss in the later second trimester, but limited evidence exists for individuals between 12 and 18 weeks of gestation.

This study aims to evaluate both the prevalence of breast symptoms and the effectiveness of cabergoline for preventing these symptoms among individuals undergoing abortion or pregnancy loss between 12 and 18 weeks of gestation.

The study will include two phases conducted at Maimonides Medical Center. In the first phase, participants will complete a survey assessing baseline breast symptoms prior to the abortion or pregnancy loss procedure. The survey will use the Bristol Breast Symptoms Inventory, a validated instrument that measures the severity of breast engorgement, milk leakage, tenderness, and the need for pain relief. This phase will allow researchers to estimate how frequently breast symptoms occur in this population.

In the second phase, participants will be enrolled in a double-blind randomized controlled trial. Participants will be randomly assigned to receive either a single oral dose of cabergoline (1 mg) or a placebo approximately one hour after the abortion or pregnancy loss procedure. Both participants and clinical providers will be blinded to the treatment assignment.

Participants will complete follow-up surveys on days 2, 3, 4, 7, and 14 after the procedure to assess the presence and severity of breast symptoms as well as the level of bother caused by these symptoms. The primary outcome of the study will be the proportion of participants reporting breast symptoms four days after the procedure. Secondary outcomes include the severity of individual breast symptoms, overall symptom bother, and participant satisfaction.

A subset of approximately 20 participants will also be invited to provide blood samples at several time points during the study to measure serum prolactin levels. These measurements will help evaluate the biological effect of cabergoline on lactation-related hormone levels. Participation in blood sampling will be optional and not required for participation in the main study.

By evaluating both the frequency of breast symptoms and the effectiveness of cabergoline for preventing them, this study aims to improve clinical care and patient comfort for individuals undergoing abortion or pregnancy loss in the early second trimester.

Interventions

• Drug Cabergoline
  Participants will receive a single oral dose of 1 mg of Cabergoline administered approximately one hour after completion of the abortion or pregnancy loss procedure. Cabergoline is a dopamine agonist that suppresses prolactin secretion and is used in this study to inhibit lactation and reduce breast symptoms.
• Drug Placebo
  Participants will receive a single oral dose of a placebo tablet administered approximately one hour after completion of the abortion or pregnancy loss procedure. The placebo will be identical in appearance to the cabergoline tablet and contains no active medication

Primary outcome measures

• Proportion of Participants With Breast Symptoms 4 Days After Abortion or Pregnancy Loss [Time frame: 4 days after abortion or pregnancy loss]

Secondary outcome measures (1)

• Participant-Reported Bother/Satisfaction From Breast Symptoms & Serum Prolactin Levels [Time frame: Days 0, 2, 3, 4, 7, and 14 after abortion or pregnancy loss]

Eligibility criteria

Inclusion criteria

• Pregnant people aged 18 years or older
• Gestational age between 12 and 18 weeks
• Undergoing treatment for spontaneous or induced abortion at Maimonides Medical Center
• Able to provide informed consent
• Willing and able to complete study surveys

Exclusion criteria

• Prior mastectomy
• Currently breastfeeding
• Current use of a dopamine agonist or dopamine antagonist medication
• Known contraindication to Cabergoline according to the medication prescribing information

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Maimonides Medical Center — Brooklyn

Publications

• Henkel A, Johnson SA, Reeves MF, Cahill EP, Blumenthal PD, Shaw KA. Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jun 1;141(6):1115-1123. doi: 10.1097/AOG.0000000000005190. Epub 2023 May 3. PMID 37486652
• Henkel A, Cahill EP, Chavez S, Shorter JM, Amaya SI, Kaur S, Soltani A, Caron J, Crowe S, Williams Z, Mastey N, Lyell DJ, Shaw KA. Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial. Obstet Gynecol. 2026 Feb 1;147(2):277-284. doi: 10.1097/AOG.0000000000006137. Epub 2025 Dec 5. PMID 41538804
• Single dose cabergoline versus bromocriptine in inhibition of puerperal lactation: randomised, double blind, multicentre study. European Multicentre Study Group for Cabergoline in Lactation Inhibition. BMJ. 1991 Jun 8;302(6789):1367-71. doi: 10.1136/bmj.302.6789.1367. PMID 1676318
• Yang Y, Boucoiran I, Tulloch KJ, Poliquin V. Is Cabergoline Safe and Effective for Postpartum Lactation Inhibition? A Systematic Review. Int J Womens Health. 2020 Mar 9;12:159-170. doi: 10.2147/IJWH.S232693. eCollection 2020. PMID 32210637
• Harris K, Murphy KE, Horn D, MacGilivray J, Yudin MH. Safety of Cabergoline for Postpartum Lactation Inhibition or Suppression: A Systematic Review. J Obstet Gynaecol Can. 2020 Mar;42(3):308-315.e20. doi: 10.1016/j.jogc.2019.03.014. Epub 2019 Jul 6. PMID 31285168
• Giorda G, de Vincentiis S, Motta T, Casazza S, Fadin M, D'Alberton A. Cabergoline versus bromocriptine in suppression of lactation after cesarean delivery. Gynecol Obstet Invest. 1991;31(2):93-6. doi: 10.1159/000293109. PMID 2037265
• Rayburn WF. Clinical commentary: the bromocriptine (Parlodel) controversy and recommendations for lactation suppression. Am J Perinatol. 1996 Feb;13(2):69-71. doi: 10.1055/s-2007-994294. PMID 8672187
• Bernard N, Jantzem H, Becker M, Pecriaux C, Benard-Laribiere A, Montastruc JL, Descotes J, Vial T; French Network of Regional Pharmacovigilance Centres. Severe adverse effects of bromocriptine in lactation inhibition: a pharmacovigilance survey. BJOG. 2015 Aug;122(9):1244-51. doi: 10.1111/1471-0528.13352. Epub 2015 Mar 11. PMID 25761676

Identifiers

NCT: NCT07492160 · 2025-07-24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗