Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion

Purpose

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.

Conditions

  • Lactation Suppressed
  • Second Trimester Abortion

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Northwestern Medical Center
Chicago, Illinois 60611
Contact:
Leanne McCloskey
312-926-8678
erin.fleurant@nm.org

More Details

Status
Recruiting
Sponsor
Northwestern University

Study Contact