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

NCT ID: NCT06029673

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-07
• Study Completion Date: 2025-07-01

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.

Detailed Description

This study is a double-blinded, placebo-controlled, gestational-age stratified superiority trial of those undergoing abortion or intrauterine fetal demise between 16 and 20-weeks gestation at Stanford Health Care. Participants will be randomized to either cabergoline 1 mg or placebo the day of procedure. Participants will complete a survey to assess symptoms, using the validated Bristol Breast Symptoms Inventory, and side-effects at baseline and Day 2, 4, 7, and 14 after the procedure. The study plan is to recruit 72 subjects powered to detect a 45% decrease in those reporting breast symptoms compared to the control group.

This study has the potential to improve overall patient experience by validating the routine use of cabergoline for lactation inhibition in the early second-trimester after abortion or pregnancy loss.

Conditions

Lactation Suppressed

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Cabergoline

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.

Group Type: EXPERIMENTAL

Cabergoline 1 MG

Intervention Type: DRUG

Dopamine agonist

Interventions

Cabergoline 1 MG

Dopamine agonist

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Dosintex

Eligibility Criteria

Inclusion Criteria

• 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

• 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

Exclusion Criteria

18 Years Female No No

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Planned Parenthood Mar Monte

UNKNOWN

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Planned Parenthood - San Jose Central Health Center

San Jose, California, United States

Stanford University

Stanford, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

71540

Identifier Type: -

Identifier Source: org_study_id