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Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion

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Northwestern University

Status and phase

Enrolling
Phase 4

Conditions

Lactation Suppressed
Second Trimester Abortion

Treatments

Drug: Cabergoline
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06123026
STU00218555

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups, including a placebo group

Cabergoline
Experimental group
Description:
1mg oral cabergoline administered once after patient's procedure
Treatment:
Drug: Cabergoline
Placebo
Placebo Comparator group
Description:
1 tablet encapsulated placebo by Investigational Drug Pharmacy administered once after patient's procedure
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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