Recruiting
Phase 2

Cabergoline

Sponsor:

Maimonides Medical Center

Code:

NCT07492160

Conditions

Pregnancy

Abortion

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cabergoline

Placebo

Study Details

Brief 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

Conditions

Pregnancy

Abortion

Study ID

NCT07492160

Start date

Mar 16, 2026

Status verified date

Mar, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

348 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cabergoline

Participants undergoing abortion or pregnancy loss between 12 and 18 weeks of gestation will receive a single 1 mg oral dose of Cabergoline approximately one hour after the procedure. Participants will complete baseline and follow-up surveys assessing breast symptoms, including breast engorgement, milk leakage, tenderness, and need for pain relief, at multiple time points through 14 days after the procedure. A subset of participants may also provide blood samples for measurement of serum prolactin levels.

placebo comparator: Placebo

Participants undergoing abortion or pregnancy loss between 12 and 18 weeks of gestation will receive a single oral dose of placebo approximately one hour after the procedure. Participants will complete baseline and follow-up surveys assessing breast symptoms, including breast engorgement, milk leakage, tenderness, and need for pain relief, at multiple time points through 14 days after the procedure. A subset of participants may also provide blood samples for measurement of serum prolactin levels.

Interventions

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.

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 measure

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

Central Contacts and Locations

Central contacts

June Ng, MD

718-283-7048JuNg@maimo.org

Olivia Sher, MPH

718-283-7962OSher@maimo.org

Locations

Maimonides Medical Center

Recruiting

Brooklyn, New York, United States, 11219

Contacts

June Ng, MD

718-283-7048JuNg@maimo.org

Principal Investigator:

June Ng, MD

More Information

Sponsor

Maimonides Medical Center

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Keywords

  • cabergoline
  • pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maimonides Medical Center on 2026-03-25.