RecruitingPhase 4NCT06123026

Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion

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


Sponsor

Northwestern University

Enrollment

200 participants

Start Date

Dec 18, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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)

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Interventions

DRUGCabergoline

1mg oral cabergoline given to participants once

DRUGPlacebo

1 encapsulated placebo tablet given to participants after procedure


Locations(1)

Northwestern Medical Center

Chicago, Illinois, United States

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NCT06123026