Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial.
Andrea Henkel, Sarah A Johnson, Matthew F Reeves...
https://pubmed.ncbi.nlm.nih.gov/37486652Actively Recruiting
Phase 2
Age: 18Years +
FEMALE
ID07492160
Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms After 12-18 Week Abortion or Pregnancy Loss: A Pilot and Randomized Controlled Trial
Led by Maimonides Medical Center · Updated on 2026-03-25
348
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to learn if cabergoline can prevent lactation and reduce breast symptoms like engorgement, milk leakage, tenderness, and pain in pregnant people aged 18 or older who experience abortion or pregnancy loss between 12 and 18 weeks of gestation. The study compares cabergoline to a placebo to see if it lowers the number of participants with breast symptoms and eases symptom severity and discomfort. This study also explores how common breast symptoms are in this early second trimester group. Participants will be randomly assigned to receive a single oral dose of either 1 mg cabergoline or a placebo about one hour after their abortion or pregnancy loss procedure. Both groups will complete surveys before and after the procedure to track breast symptoms and related bother. A small group of participants may also provide blood samples to measure prolactin levels, which relate to lactation. Throughout the study, participants will fill out baseline and multiple follow-up surveys on days 2, 3, 4, 7, and 14 after the procedure. These surveys assess breast symptoms and how bothersome they are. The main measurement is the proportion of participants with breast symptoms four days after the procedure. Safety and satisfaction are also monitored. Blood samples for hormone levels are optional and collected at selected times. The study is designed to improve care and comfort after abortion or pregnancy loss in the early second trimester.
CONDITIONS
Brief Title
Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Prior mastectomy
- Currently breastfeeding
- Current use of a dopamine agonist or dopamine antagonist medication
- Known contraindication to Cabergoline according to the medication prescribing information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - Single day (day of procedure)
Participants receive a single oral dose of cabergoline or placebo approximately one hour after the abortion or pregnancy loss procedure.
1 treatment visit (in-person)
Follow-up
Duration - 14 days after the procedure
Participants complete follow-up surveys to assess breast symptoms and symptom bother after the procedure. A subset may provide optional blood samples to measure hormone levels.
5 follow-up visits on days 2, 3, 4, 7, and 14 (remote or in-person)
Trial Site Locations
Total: 1 location
1
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Actively Recruiting
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Research Team
J
June Ng, MD
O
Olivia Sher, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial.
Andrea Henkel, Erica P Cahill, Sonia Chavez...
https://pubmed.ncbi.nlm.nih.gov/41538804Single dose cabergoline versus bromocriptine in inhibition of puerperal lactation: randomised, double blind, multicentre study. European Multicentre Study Group for Cabergoline in Lactation Inhibition.
https://pubmed.ncbi.nlm.nih.gov/1676318Is Cabergoline Safe and Effective for Postpartum Lactation Inhibition? A Systematic Review.
Yang Yang, Isabelle Boucoiran, Karen J Tulloch...
https://pubmed.ncbi.nlm.nih.gov/32210637Safety of Cabergoline for Postpartum Lactation Inhibition or Suppression: A Systematic Review.
Kristin Harris, Kellie E Murphy, Daphne Horn...
https://pubmed.ncbi.nlm.nih.gov/31285168Cabergoline versus bromocriptine in suppression of lactation after cesarean delivery.
G Giorda, S de Vincentiis, T Motta...
https://pubmed.ncbi.nlm.nih.gov/2037265Clinical commentary: the bromocriptine (Parlodel) controversy and recommendations for lactation suppression.
W F Rayburn
https://pubmed.ncbi.nlm.nih.gov/8672187Severe adverse effects of bromocriptine in lactation inhibition: a pharmacovigilance survey.
N Bernard, H Jantzem, M Becker...
https://pubmed.ncbi.nlm.nih.gov/25761676Prevention of breast pain and milk secretion with bromocriptine after second-trimester abortion.
A Nyboe Andersen, P Damm, A Tabor...
https://pubmed.ncbi.nlm.nih.gov/2220345