A Reduced Dose of Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss (LISTA3)
Study Overview
Detailed Description
Most people do not expect breast engorgement following a second-trimester pregnancy loss yet nearly all report bothersome symptoms. Prolactin is the primary hormone responsible for milk production. The dopamine agonist class, including cabergoline, prevents prolactin release, leading to lactation inhibition. Based on dose-finding studies after a full-term birth, a one-time dose of cabergoline 1 mg is offered for lactation inhibition for full-term fetal/neonatal loss or for those with contraindications to breastfeeding.
Recently, our own research found a single dose of cabergoline 1 mg effectively prevents breast symptoms after a second-trimester abortion or stillbirth. However, cabergoline is relatively expensive and associated with side effects such as dizziness, headache, and nausea.
As serum prolactin levels are much lower in the second trimester, it is plausible that a lower dose of cabergoline may still be effective in preventing lactation following a second-trimester loss. Our overarching hypothesis is that a lower dose of cabergoline given after a second-trimester abortion or pregnancy loss will still prevent breast symptoms while also decreasing the frequency and severity of side effects. A lower dose would additionally save money for the healthcare system and patient. For this pilot study, we first plan to test whether a lower dose of cabergoline can reduce serum prolactin levels to physiologic levels.
This is a pilot double-blinded, gestational-age stratified trial of those with fetal demise, stillbirth, or seeking abortion care between 16- and 26-weeks gestation. The investigators will determine if the proportion of participants receiving cabergoline 0.5 mg with normal serum prolactin level on Day 4 is non-inferior to those receiving cabergoline 1 mg.
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnant people, ages 18 years or older
- Intrauterine pregnancy between 16/0-25/6 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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Cabergoline 1 mg tab
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.
|
Cabergoline
Other Names:
|
|
Experimental: Cabergoline 0.5 mg tab
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 0.5mg orally with juice or water by the clinician or study investigator.
|
Cabergoline
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with serum prolactin level less than 23 ng/mL
Time Frame: Day 4
|
Comparison of the proportion of participants receiving cabergoline 0.5 mg with normal serum prolactin level (defined as less than 23ng/mL) to those receiving cabergoline 1 mg
|
Day 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with breast symptoms
Time Frame: Day 4
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 80200
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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