Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion

Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion: a Randomized Controlled Trial

The goal of this clinical trial is to compare breast symptoms (lactation, engorgement, etc) of individuals who undergo a procedure for second trimester of pregnancy loss between 16 weeks and 20 weeks gestational age. The participants will be randomly placed in two groups, one with a placebo tablet and one with medication called "cabergoline" which are taken immediately after their procedure. Researchers will compare groups to see if there are any significant differences in breast symptoms.

Study Overview

• Status: Recruiting
• Conditions: Second Trimester Abortion; Lactation Suppressed
• Intervention / Treatment: Drug: Cabergoline; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Medical Center
      • Contact: Leanne McCloskey; Phone Number: 312-926-8678; Email: erin.fleurant@nm.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• pregnant individuals seeking termination of pregnancy after 16w0d gestation and up to 19w6d gestation. this includes management of intrauterine demises
• ages 18 to 50
• con provide informed consent in English

Exclusion Criteria:

• Age under 18 or above 50
• gestational ages before 16 weeks 0 days or after 20 weeks 0 days
• unable to provide written consent in English
• hypertensive disorder
• uncontrolled hypertension or known hypersensitivity to ergot derivatives
• History of cardiac valvular disorders
• history of pulmonary fibrosis
• documented bipolar schizophrenia
• documented allergy to medication, including lactose intolerance (placebo pill involves lactose)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cabergoline; 1mg oral cabergoline administered once after patient's procedure	Drug: Cabergoline; 1mg oral cabergoline given to participants once
Placebo Comparator: Placebo; 1 tablet encapsulated placebo by Investigational Drug Pharmacy administered once after patient's procedure	Drug: Placebo; 1 encapsulated placebo tablet given to participants after procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
breast symptoms	Using the bristol breast inventory to assess breast symptoms (engorgement, lactation, etc).	3 days post procedure and two weeks post procedure

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: October 28, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Cabergoline
• Other Study ID Numbers: STU00218555

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No