Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion

NCT ID: NCT06123026

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-18

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lactation Suppressed Second Trimester Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cabergoline

1mg oral cabergoline administered once after patient's procedure

Group Type EXPERIMENTAL

Cabergoline

Intervention Type DRUG

1mg oral cabergoline given to participants once

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 encapsulated placebo tablet given to participants after procedure

Interventions

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Cabergoline

1mg oral cabergoline given to participants once

Intervention Type DRUG

Placebo

1 encapsulated placebo tablet given to participants after procedure

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Northwestern Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Leanne McCloskey

Role: primary

312-926-8678

Other Identifiers

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STU00218555

Identifier Type: -

Identifier Source: org_study_id

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