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Recruiting NCT06123026

Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion

Phase IV Interventional Lactation Suppressed Second Trimester Abortion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cabergoline, Placebo.
Who it may be relevant to
Registry conditions: Lactation Suppressed, Second Trimester Abortion. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Northwestern Medical Center — Chicago

Identifiers

NCT: NCT06123026 · STU00218555

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗