Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms

Summary

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

Timeline

Start

2026-03-16

Primary completion

2028-02

Completion

2028-04

Publications

• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background Nyboe Andersen A, Damm P, Tabor A, Pedersen IM, Harring M. Prevention of breast pain and milk secretion with bromocriptine after second-trimester abortion. Acta Obstet Gynecol Scand. 1990;69(3):235-8. doi: 10.3109/00016349009028686.

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