Lactation Suppressed
Conditions
Keywords
abortion, fetal demise, lactation, engorgement
Brief summary
Breast pain following second-trimester abortion is common. Breast engorgement and milk leakage following second-trimester perinatal loss and abortion can cause both physical pain and emotional distress. Dopamine agonists have previously been shown to be effective in lactation inhibition for third-trimester fetal/neonatal loss or contraindications to breastfeeding. The investigator's prior work demonstrated that compared to placebo, a single dose of cabergoline was effective in preventing breast symptoms after abortion or loss 18-28 weeks. As lactogenesis starts as early as 16 weeks gestation, the investigators hope to determine the efficacy of cabergoline earlier in the second trimester,16-20 weeks.
Detailed description
This study is a double-blinded, placebo-controlled, gestational-age stratified superiority trial of those undergoing abortion or intrauterine fetal demise between 16 and 20-weeks gestation at Stanford Health Care. Participants will be randomized to either cabergoline 1 mg or placebo the day of procedure. Participants will complete a survey to assess symptoms, using the validated Bristol Breast Symptoms Inventory, and side-effects at baseline and Day 2, 4, 7, and 14 after the procedure. The study plan is to recruit 72 subjects powered to detect a 45% decrease in those reporting breast symptoms compared to the control group. This study has the potential to improve overall patient experience by validating the routine use of cabergoline for lactation inhibition in the early second-trimester after abortion or pregnancy loss.
Interventions
DRUGCabergoline 1 MG
Dopamine agonist
DRUGPlacebo
Placebo
Sponsors
Planned Parenthood Mar Monte
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant people, ages 18 years or older * Intrauterine pregnancy between 16/0-19/6 weeks of gestation age (by ultrasound dating performed prior to or same day of enrollment visit) * Consented for an induced, elective abortion or undergoing management of fetal demise * English or Spanish speaking * Able to consent for a research study, literate in English or Spanish * Willing to comply with study procedures and follow-up * Access to smart phone throughout study
Exclusion criteria
18 Years Female No No Inclusion Criteria: * Pregnant people, ages 18 years or older * Intrauterine pregnancy between 18/0-28/0 weeks of gestation age (by ultrasound dating performed prior to or same day of enrollment visit) * Consented for an induced, elective abortion or undergoing induction for demise * English or Spanish speaking * Able to consent for a research study, literate in English or Spanish * Willing to comply with study procedures and follow-up * Access to smart phone throughout study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Breast Pain | Day 4 after procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Side-effects | Cumulative over 2 weeks | 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. |
| Number of Participants Reporting Significant Bother From Breast Pain | Day 4 after procedure | Assessed using a Facial Pain Score; scale range 0-6 (higher scores indicate greater pain), with significant bother \>=4 |
| Number of Participants Reporting Significant Bother From Side-effects | Cumulative over 2 weeks | Assessed using a Facial Pain Score; scale range 0-6 (higher scores indicate greater pain), with significant bother \>=4 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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. | 34 |
| Total | 66 |
Baseline characteristics
| Characteristic | Cabergoline | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 34 Participants | 66 Participants |
| Age, Continuous | 27.8 years STANDARD_DEVIATION 7.9 | 28.6 years STANDARD_DEVIATION 7.2 | 28.2 years STANDARD_DEVIATION 7.5 |
| Prior breastfeeding experience | 11 Participants | 17 Participants | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 18 Participants | 6 Participants | 24 Participants |
| Race (NIH/OMB) White | 7 Participants | 18 Participants | 25 Participants |
| Region of Enrollment United States | 32 Participants | 34 Participants | 66 Participants |
| Sex: Female, Male Female | 32 Participants | 34 Participants | 66 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 35 |
| other Total, other adverse events | 0 / 34 | 0 / 35 |
| serious Total, serious adverse events | 0 / 34 | 0 / 35 |
Outcome results
Primary
Number of Participants Reporting Breast Pain
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.
Time frame: Day 4 after procedure
Population: ITT analysis - participants that did not provide any additional surveys beyond date of enrollment were excluded
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabergoline | Number of Participants Reporting Breast Pain | 16 Participants |
| Placebo | Number of Participants Reporting Breast Pain | 30 Participants |
Secondary
Number of Participants Experiencing Side-effects
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.
Time frame: Cumulative over 2 weeks
Population: ITT analysis - participants that did not provide any additional surveys beyond date of enrollment were excluded
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabergoline | Number of Participants Experiencing Side-effects | 26 Participants |
| Placebo | Number of Participants Experiencing Side-effects | 31 Participants |
Secondary
Number of Participants Reporting Significant Bother From Breast Pain
Assessed using a Facial Pain Score; scale range 0-6 (higher scores indicate greater pain), with significant bother \>=4
Time frame: Day 4 after procedure
Population: ITT analysis - participants that did not provide any additional surveys beyond date of enrollment were excluded
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabergoline | Number of Participants Reporting Significant Bother From Breast Pain | 1 Participants |
| Placebo | Number of Participants Reporting Significant Bother From Breast Pain | 7 Participants |
Secondary
Number of Participants Reporting Significant Bother From Side-effects
Assessed using a Facial Pain Score; scale range 0-6 (higher scores indicate greater pain), with significant bother \>=4
Time frame: Cumulative over 2 weeks
Population: ITT analysis - participants that did not provide any additional surveys beyond date of enrollment were excluded
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cabergoline | Number of Participants Reporting Significant Bother From Side-effects | 1 Participants |
| Placebo | Number of Participants Reporting Significant Bother From Side-effects | 1 Participants |