Trial Outcomes & Findings for Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Loss (NCT NCT04701333)
NCT ID: NCT04701333
Last Updated: 2024-02-13
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
73 participants
Primary outcome timeframe
Day 4 after procedure
Results posted on
2024-02-13
Participant Flow
Participant milestones
| Measure |
Cabergoline
After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator.
Cabergoline 1 MG: Dopamine agonist
|
Placebo
After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered a placebo pill orally with juice or water by the clinician or study investigator.
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
37
|
|
Overall Study
COMPLETED
|
33
|
29
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
Reasons for withdrawal
| Measure |
Cabergoline
After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator.
Cabergoline 1 MG: Dopamine agonist
|
Placebo
After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered a placebo pill orally with juice or water by the clinician or study investigator.
Placebo: Placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
7
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Loss
Baseline characteristics by cohort
| Measure |
Cabergoline
n=36 Participants
After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator.
Cabergoline 1 MG: Dopamine agonist
|
Placebo
n=37 Participants
After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered a placebo pill orally with juice or water by the clinician or study investigator.
Placebo: Placebo
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 5.4 • n=99 Participants
|
31.6 years
STANDARD_DEVIATION 5.7 • n=107 Participants
|
31.1 years
STANDARD_DEVIATION 5.6 • n=206 Participants
|
|
Sex/Gender, Customized
Woman
|
35 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Non-binary
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Gestational age at time of procedure
|
148.9 days
STANDARD_DEVIATION 13.4 • n=99 Participants
|
147.7 days
STANDARD_DEVIATION 12.8 • n=107 Participants
|
148.3 days
STANDARD_DEVIATION 13.0 • n=206 Participants
|
|
Nulliparous
|
16 participants
n=99 Participants
|
25 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
Indication
Undesired pregnancy
|
14 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Indication
Fetal anomaly
|
20 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Indication
Maternal comorbidity
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Indication
Fetal demise
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 4 after procedurePopulation: Participants who returned survey data for this outcome are included in the analysis.
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.
Outcome measures
| Measure |
Cabergoline
n=36 Participants
After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator.
Cabergoline 1 MG: Dopamine agonist
|
Placebo
n=33 Participants
After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered a placebo pill orally with juice or water by the clinician or study investigator.
Placebo: Placebo
|
|---|---|---|
|
Number of Participants Reporting Breast Pain
|
10 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Participants who returned survey data for this outcome are included in the analysis.
Participants selected from previously documented side-effects from the dopaminergic class or free-text. Participants may have reported more than one side-effect.
Outcome measures
| Measure |
Cabergoline
n=36 Participants
After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator.
Cabergoline 1 MG: Dopamine agonist
|
Placebo
n=36 Participants
After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered a placebo pill orally with juice or water by the clinician or study investigator.
Placebo: Placebo
|
|---|---|---|
|
Number of Participants Experiencing Side-effects
Nausea/ vomiting
|
5 Participants
|
2 Participants
|
|
Number of Participants Experiencing Side-effects
Headache
|
12 Participants
|
9 Participants
|
|
Number of Participants Experiencing Side-effects
Dizziness/ lightheadness
|
7 Participants
|
7 Participants
|
|
Number of Participants Experiencing Side-effects
Constipation
|
14 Participants
|
18 Participants
|
|
Number of Participants Experiencing Side-effects
Acid reflux
|
3 Participants
|
2 Participants
|
|
Number of Participants Experiencing Side-effects
Fatigue
|
12 Participants
|
11 Participants
|
|
Number of Participants Experiencing Side-effects
Lower extremity edema
|
4 Participants
|
4 Participants
|
|
Number of Participants Experiencing Side-effects
Hot flashes
|
2 Participants
|
9 Participants
|
|
Number of Participants Experiencing Side-effects
Palpitations
|
1 Participants
|
1 Participants
|
|
Number of Participants Experiencing Side-effects
Anxiety
|
4 Participants
|
3 Participants
|
|
Number of Participants Experiencing Side-effects
Insomnia
|
8 Participants
|
11 Participants
|
|
Number of Participants Experiencing Side-effects
Visual disturbance
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 4 after procedurePopulation: Participants who returned survey data for this outcome are included in the analysis.
Assessed using a Facial Pain Score (scale range 0-6, significant bother \>=4)
Outcome measures
| Measure |
Cabergoline
n=36 Participants
After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator.
Cabergoline 1 MG: Dopamine agonist
|
Placebo
n=33 Participants
After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered a placebo pill orally with juice or water by the clinician or study investigator.
Placebo: Placebo
|
|---|---|---|
|
Number of Participants Reporting Significant Bother From Breast Pain
|
1 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 4 after procedurePopulation: Participants who returned for serum blood draws
A subset of participants returned blood tests to measure effectiveness of drug
Outcome measures
| Measure |
Cabergoline
n=3 Participants
After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator.
Cabergoline 1 MG: Dopamine agonist
|
Placebo
n=3 Participants
After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered a placebo pill orally with juice or water by the clinician or study investigator.
Placebo: Placebo
|
|---|---|---|
|
Serum Prolactin Level
|
6.5 ng/mL
Standard Deviation 2.2
|
18.0 ng/mL
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Day 4 after procedurePopulation: Participants who returned survey data for this outcome are included in the analysis.
Assessed using a Facial Pain Score (scale range 0-6, significant bother \>=4)
Outcome measures
| Measure |
Cabergoline
n=36 Participants
After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator.
Cabergoline 1 MG: Dopamine agonist
|
Placebo
n=33 Participants
After the completion of the surgical procedure or medical induction for the second-trimester abortion or fetal loss, the participant will be administered a placebo pill orally with juice or water by the clinician or study investigator.
Placebo: Placebo
|
|---|---|---|
|
Number of Participants Reporting Significant Bother From Side-effects
|
2 Participants
|
6 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place