Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion

Phase 4

Recruiting

• Conditions: Lactation Suppressed; Second Trimester Abortion
• Interventions: Drug: Placebo; Drug: Cabergoline

• Registration Number: NCT06123026
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-28
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-08
• Study Start: 2023-12-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1 tablet encapsulated placebo by Investigational Drug Pharmacy administered once after patient's procedure
Cabergoline	Cabergoline	1mg oral cabergoline administered once after patient's procedure

Primary Outcome Measures

Name	Time	Method
breast symptoms	3 days post procedure and two weeks post procedure	Using the bristol breast inventory to assess breast symptoms (engorgement, lactation, etc).

Trial Locations

Locations (1)

Northwestern Medical Center; 🇺🇸 Chicago, Illinois, United States