Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Loss

NCT04701333 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 58470
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

This research study investigates the use of a drug, cabergoline, given immediately after second-trimester abortion or perinatal loss to decrease breast engorgement. Cabergoline is a medication approved for the symptomatic treatment of pituitary adenomas that result in a hyperprolactinemic state (a brain tumor that results in milk leakage). The benefit of stopping milk leakage has also been studied and used in populations who shouldn't breastfeed. The investigators aim to clarify if cabergoline is effective in preventing breast engorgement and milk leakage after second-trimester abortions or perinatal loss (stillbirth). Breast engorgement causes physical pain and emotional distress as lactation is uniquely associated with parenthood and those undergoing second-trimester abortions are doing so because they choose not to parent or a previously desired pregnancy is now complicated by anomalies. As there are no current recommendations for management of this painful engorgement beyond icepacks and support bras, the investigators aim to validate the use of this pharmacologic option in this setting.

Conditions

Lactation Suppressed

Keywords

abortion; intrauterine fetal demise; second-trimester; 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 (4)

• Number of Participants Experiencing Side-effects

  2 weeks

• Number of Participants Reporting Significant Bother From Breast Pain

  Day 4 after procedure

• Serum Prolactin Level

  Day 4 after procedure

• Number of Participants Reporting Significant Bother From Side-effects

  Day 4 after procedure

Study Arms (2)

Cabergoline

EXPERIMENTAL

After the completion of the surgical procedure or medical induction for the 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 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: Dostinex

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 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

You may not qualify if:

• Prior mastectomy (breast reduction or chest masculinization surgery acceptable)
• Currently breastfeeding
• Currently receiving dopamine agonist therapy for other indication (prolactinoma, Cushings syndrome, acromegaly, restless leg syndrome)
• Contraindication to cabergoline (as per package insert)
• Uncontrolled hypertension - defined as baseline BP \> 150/100, or chronic hypertension requiring more than one baseline medication, or 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

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

• Henkel A, Reeves MF, Shaw KA. The experience of breast symptoms after second-trimester abortion or pregnancy loss. Am J Obstet Gynecol. 2024 Mar;230(3):e3-e5. doi: 10.1016/j.ajog.2023.10.025. Epub 2023 Oct 18. No abstract available.

  PMID: 37863161 DERIVED

• Henkel A, Johnson SA, Reeves MF, Cahill EP, Blumenthal PD, Shaw KA. Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jun 1;141(6):1115-1123. doi: 10.1097/AOG.0000000000005190. Epub 2023 May 3.

  PMID: 37486652 DERIVED

MeSH Terms

Conditions

Stillbirth; Breast Feeding; Hyperemia

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Fetal Death; 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: Principal Investigator
• 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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 8, 2021
• Study Start: April 1, 2021
• Primary Completion: June 24, 2022
• Study Completion: March 1, 2023
• Last Updated: February 13, 2024
• Results First Posted: April 5, 2023

Record last verified: 2024-01

Data Sharing

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

Locations

US (1)