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

Lactation Suppressed Clinical Trial

— eLISTA  

Official title:

Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06029673
• Other study ID #: 71540
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: February 7, 2024
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 72
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

18 Years Female No No

Inclusion Criteria:

• 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:

• 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

Related Conditions & MeSH terms

• Lactation Suppressed

Intervention

Drug:
• Cabergoline 1 MG
Dopamine agonist
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Planned Parenthood - San Jose Central Health Center	San Jose	California
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Planned Parenthood Mar Monte

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Experiencing Side-effects	Participants selected from previously documented side-effects from the dopaminergic class or entered as free-text. Participants may have reported more than one side-effect.	Cumulative over 2 weeks
Secondary	Number of Participants Reporting Significant Bother From Breast Pain	Assessed using a Facial Pain Score (scale range 0-6, significant bother >=4)	Day 4 after procedure
Secondary	Number of Participants Reporting Significant Bother From Side-effects	Assessed using a Facial Pain Score (scale range 0-6, significant bother >=4)	Cumulative over 2 weeks