Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion

Second Trimester Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06123026
• Other study ID #: STU00218555
• Status: Recruiting
• Phase: Phase 4
• Start date: December 18, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lactation Suppressed
• Second Trimester Abortion

Intervention

Drug:
• Cabergoline
1mg oral cabergoline given to participants once
• Placebo
1 encapsulated placebo tablet given to participants after procedure

Locations

Country	Name	City	State
United States	Northwestern Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	breast symptoms	Using the bristol breast inventory to assess breast symptoms (engorgement, lactation, etc).	3 days post procedure and two weeks post procedure