Pharmacological Inhibition of Lactation After 16 to 20 We... | NCT06123026

Studies
Pharmacological Inhibition of Lactation After 16 to 20 Week Abortion

NCT06123026

Sponsor

Northwestern University

Status

Recruiting

Last Update Posted

May 29, 2024Actual

Enrollment

200Estimated

Phase

Phase 4

Conditions

Lactation Suppressed
Second Trimester Abortion

Interventions

Cabergoline
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 18, 2023Actual

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Oct 28, 2023

First Submission Date that Met QC Criteria

Nov 7, 2023

First Posted Date

Nov 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2024

Last Update Posted Date

May 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cabergoline	Experimental	1mg oral cabergoline administered once after patient's procedure	Drug: Cabergoline
Placebo	Placebo Comparator	1 tablet encapsulated placebo by Investigational Drug Pharmacy administered once after patient's procedure	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cabergoline	Drug	1mg oral cabergoline given to participants once	Cabergoline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
breast symptoms	Using the bristol breast inventory to assess breast symptoms (engorgement, lactation, etc).	3 days post procedure and two weeks post procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern Medical Center	Recruiting	Chicago	Illinois	60611	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 10, 2026			Feb 26, 2026	3

Intervention Browse Module

MeSH Terms

ID	Term
D000077465	Cabergoline

Ancestor Terms

ID	Term
D004873	Ergolines
D004876	Ergot Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided