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NCT Number: NCT06123026

Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion

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.

Recruiting

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Key information

Conditions

Lactation Suppressed Second Trimester Abortion

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern Medical Center

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Leanne McCloskey

CONTACT

[email protected]

312-926-8678

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

cabergoline

Drug

1mg oral cabergoline given to participants once

Placebo

Drug

1 encapsulated placebo tablet given to participants after procedure

Primary outcomes

  1. breast symptoms

    Time frame: 3 days post procedure and two weeks post procedure

    Using the bristol breast inventory to assess breast symptoms (engorgement, lactation, etc).

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2023
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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