Trial Outcomes & Findings for Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss (NCT NCT06029673)

Last Updated: 2025-10-03

Results Overview

Participants will assess their breast symptoms using the validated Bristol Breast Inventory survey to assess 4 domains of breast symptoms: tenderness, engorgement, leaking milk, pain relief. Participants who indicated symptoms in any of these areas met the criteria for this outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

69 participants

Primary outcome timeframe

Day 4 after procedure

Results posted on

2025-10-03

Participant Flow

Participant milestones

Participant milestones
Measure	Cabergoline After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant is administered cabergoline 1mg orally with juice or water by the clinician or study investigator.	Placebo After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant is administered a placebo pill orally with juice or water by the clinician or study investigator.
Overall Study STARTED	34	35
Overall Study COMPLETED	32	34
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cabergoline n=32 Participants After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant is administered cabergoline 1mg orally with juice or water by the clinician or study investigator.	Placebo n=34 Participants After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant is administered a placebo pill orally with juice or water by the clinician or study investigator.	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	34 Participants n=7 Participants	66 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	27.8 years STANDARD_DEVIATION 7.9 • n=5 Participants	28.6 years STANDARD_DEVIATION 7.2 • n=7 Participants	28.2 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	34 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	18 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants n=5 Participants	6 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	32 Participants n=5 Participants	34 Participants n=7 Participants	66 Participants n=5 Participants
Prior breastfeeding experience	11 Participants n=5 Participants	17 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 4 after procedure

Population: ITT analysis - participants that did not provide any additional surveys beyond date of enrollment were excluded

Outcome measures

Outcome measures
Measure	Cabergoline n=32 Participants After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant is administered cabergoline 1mg orally with juice or water by the clinician or study investigator.	Placebo n=34 Participants After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant is administered a placebo pill orally with juice or water by the clinician or study investigator.
Number of Participants Reporting Breast Pain	16 Participants	30 Participants

SECONDARY outcome

Timeframe: Cumulative over 2 weeks

Population: ITT analysis - participants that did not provide any additional surveys beyond date of enrollment were excluded

Participants selected from previously documented side-effects from the dopaminergic class or entered as free-text. Participants may have reported more than one side-effect. The experience of dopaminergetic medication side effects may or may not be considered to be adverse events.

Outcome measures

Outcome measures
Measure	Cabergoline n=32 Participants After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant is administered cabergoline 1mg orally with juice or water by the clinician or study investigator.	Placebo n=34 Participants After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant is administered a placebo pill orally with juice or water by the clinician or study investigator.
Number of Participants Experiencing Side-effects	26 Participants	31 Participants

SECONDARY outcome

Timeframe: Day 4 after procedure

Population: ITT analysis - participants that did not provide any additional surveys beyond date of enrollment were excluded

Assessed using a Facial Pain Score; scale range 0-6 (higher scores indicate greater pain), with significant bother \>=4

Outcome measures

Outcome measures
Measure	Cabergoline n=32 Participants After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant is administered cabergoline 1mg orally with juice or water by the clinician or study investigator.	Placebo n=34 Participants After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant is administered a placebo pill orally with juice or water by the clinician or study investigator.
Number of Participants Reporting Significant Bother From Breast Pain	1 Participants	7 Participants

SECONDARY outcome

Timeframe: Cumulative over 2 weeks

Population: ITT analysis - participants that did not provide any additional surveys beyond date of enrollment were excluded

Assessed using a Facial Pain Score; scale range 0-6 (higher scores indicate greater pain), with significant bother \>=4

Outcome measures

Outcome measures
Measure	Cabergoline n=32 Participants After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant is administered cabergoline 1mg orally with juice or water by the clinician or study investigator.	Placebo n=34 Participants After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant is administered a placebo pill orally with juice or water by the clinician or study investigator.
Number of Participants Reporting Significant Bother From Side-effects	1 Participants	1 Participants

Adverse Events

Cabergoline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Team

Stanford University

Phone: (650) 497-5175

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place