Recruiting

Lactation Inhibition

Sponsor:

Northwestern University

Code:

NCT06123026

Conditions

Lactation Suppressed

Second Trimester Abortion

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Cabergoline

Placebo

Study Details

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.

Conditions

Lactation Suppressed

Second Trimester Abortion

Study ID

NCT06123026

Start date

Dec 18, 2023

Status verified date

May, 2024

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cabergoline

1mg oral cabergoline administered once after patient's procedure

placebo comparator: Placebo

1 tablet encapsulated placebo by Investigational Drug Pharmacy administered once after patient's procedure

Interventions

Cabergoline

1mg oral cabergoline given to participants once

Placebo

1 encapsulated placebo tablet given to participants after procedure

Primary outcome measure

  • breast symptoms [ Time Frame: 3 days post procedure and two weeks post procedure ]

Central Contacts and Locations

Locations

Northwestern Medical Center

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Leanne McCloskey

312-926-8678erin.fleurant@nm.org

More Information

Sponsor

Northwestern University

Last update posted

May 29, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2024-05-29.