Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2023
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2023
CompletedFirst Posted
Study publicly available on registry
November 8, 2023
CompletedStudy Start
First participant enrolled
December 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedMay 29, 2024
May 1, 2024
7 months
October 28, 2023
May 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
breast symptoms
Using the bristol breast inventory to assess breast symptoms (engorgement, lactation, etc).
3 days post procedure and two weeks post procedure
Study Arms (2)
Cabergoline
EXPERIMENTAL1mg oral cabergoline administered once after patient's procedure
Placebo
PLACEBO COMPARATOR1 tablet encapsulated placebo by Investigational Drug Pharmacy administered once after patient's procedure
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern Medical Center
Chicago, Illinois, 60611, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2023
First Posted
November 8, 2023
Study Start
December 18, 2023
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
May 29, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share