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| Name | Class |
|---|---|
| Planned Parenthood Mar Monte | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabergoline | Experimental | After the completion of the surgical procedure or medical induction for the early second-trimester abortion or fetal loss, the participant will be administered cabergoline 1mg orally with juice or water by the clinician or study investigator. |
|
| Placebo | Placebo Comparator | After the completion of the surgical procedure or medical induction for the early 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabergoline 1 MG | Drug | Dopamine agonist |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 4 after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Cumulative over 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
18 Years Female No No
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood - San Jose Central Health Center | San Jose | California | 95126 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41538804 | Derived | Henkel A, Cahill EP, Chavez S, Shorter JM, Amaya SI, Kaur S, Soltani A, Caron J, Crowe S, Williams Z, Mastey N, Lyell DJ, Shaw KA. Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial. Obstet Gynecol. 2026 Feb 1;147(2):277-284. doi: 10.1097/AOG.0000000000006137. Epub 2025 Dec 5. |
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De-identified data may be requested for meta-analysis inclusion
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-to-treat (ITT) analysis - participants that did not provide any additional surveys beyond date of enrollment were excluded
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ITT analysis - participants that did not provide any additional surveys beyond date of enrollment were excluded | Posted | Count of Participants | Participants | Day 4 after procedure |
|
14 days following drug/placebo allocation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Team | Stanford University | (650) 497-5175 | gynresearch@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2023 | Aug 18, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005313 | Fetal Death |
| D001942 | Breast Feeding |
| D006940 | Hyperemia |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
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| ID | Term |
|---|---|
| D000077465 | Cabergoline |
| ID | Term |
|---|---|
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo |
|
| 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 | Day 4 after procedure |
| 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 | Cumulative over 2 weeks |
| Stanford |
| California |
| 94305 |
| United States |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Prior breastfeeding experience | Count of Participants | Participants |
|
| 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. |
|
|
| 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. | ITT analysis - participants that did not provide any additional surveys beyond date of enrollment were excluded | Posted | Count of Participants | Participants | Cumulative over 2 weeks |
|
|
|
| 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 | ITT analysis - participants that did not provide any additional surveys beyond date of enrollment were excluded | Posted | Count of Participants | Participants | Day 4 after procedure |
|
|
|
| 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 | ITT analysis - participants that did not provide any additional surveys beyond date of enrollment were excluded | Posted | Count of Participants | Participants | Cumulative over 2 weeks |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | 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. | 0 | 35 | 0 | 35 | 0 | 35 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |