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Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion

Sponsor
Northwestern University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06123026
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
28.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion: a Randomized Controlled Trial
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cabergoline

1mg oral cabergoline administered once after patient's procedure

Drug: Cabergoline
1mg oral cabergoline given to participants once
Placebo Comparator: Placebo

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

Drug: Placebo
1 encapsulated placebo tablet given to participants after procedure

Outcome Measures

Primary Outcome Measures

  1. breast symptoms [3 days post procedure and two weeks post procedure]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern Medical Center Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Northwestern University
ClinicalTrials.gov Identifier:
NCT06123026
Other Study ID Numbers:
  • STU00218555
First Posted:
Nov 8, 2023
Last Update Posted:
Nov 8, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Cabergoline

Study Results

No Results Posted as of Nov 8, 2023