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

NCT06029673 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 71540
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lactation Suppressed

Keywords

abortion; fetal demise; lactation; engorgement

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting Breast Pain

  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.

  Day 4 after procedure

Secondary Outcomes (3)

• Number of Participants Experiencing Side-effects

  Cumulative over 2 weeks

• Number of Participants Reporting Significant Bother From Breast Pain

  Day 4 after procedure

• Number of Participants Reporting Significant Bother From Side-effects

  Cumulative over 2 weeks

Study Arms (2)

Cabergoline

EXPERIMENTAL

After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator.

Drug: Cabergoline 1 MG

Placebo

PLACEBO COMPARATOR

After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant will be administered a placebo pill orally with juice or water by the clinician or study investigator.

Drug: Placebo

Interventions

Cabergoline 1 MG DRUG

Dopamine agonist

Also known as: Dosintex

Cabergoline

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Years Female No No
• 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
• 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

Sponsors & Collaborators

• Stanford University: lead
• Planned Parenthood Mar Monte: collaborator

Study Sites (2)

Planned Parenthood - San Jose Central Health Center

San Jose, California, 95126, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Fetal Death; Breast Feeding; Hyperemia

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Research Team
• Organization: Stanford University

gynresearch@stanford.edu

(650) 497-5175

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: February 7, 2024
• Primary Completion: June 15, 2025
• Study Completion: July 1, 2025
• Last Updated: October 3, 2025
• Results First Posted: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (2)