Efficacy of Cabergoline in Inhibiting Lactation and Alleviating Breast Symptoms After 12-18 Week Abortion or Pregnancy Loss: A Pilot and Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Breast Symptoms 4 Days After Abortion or Pregnancy Loss
研究概览
简要总结
The goal of this clinical trial is to learn whether cabergoline can prevent lactation and reduce breast symptoms in pregnant people aged 18 years or older undergoing abortion or pregnancy loss between 12 and 18 weeks of gestation. The main questions it aims to answer are:
Does cabergoline decrease the proportion of participants who experience breast symptoms (including breast engorgement, milk leakage, tenderness, and need for pain relief) after abortion or pregnancy loss?
Does cabergoline reduce the severity of breast symptoms and associated bother compared with placebo?
Researchers will compare participants receiving cabergoline to those receiving placebo to determine whether cabergoline reduces the frequency and severity of breast symptoms following abortion or pregnancy loss.
Participants will:
Complete a baseline survey assessing breast symptoms prior to the abortion or pregnancy loss procedure
Receive a single oral dose of either cabergoline (1 mg) or placebo approximately one hour after the procedure
Complete follow-up surveys on days 2, 3, 4, 7, and 14 after the procedure to assess breast symptoms and related bother
A subset of participants will provide blood samples at selected time points to measure serum prolactin levels
详细描述
Breast symptoms such as breast engorgement, milk leakage, and tenderness are common after abortion or pregnancy loss in the second trimester because lactation can begin as early as 12-20 weeks of gestation. While care following abortion or pregnancy loss often focuses on pelvic symptoms, breast symptoms may also cause significant physical discomfort and emotional distress for patients. Prior research suggests that a large proportion of patients undergoing abortion or pregnancy loss between 14 and 20 weeks experience breast tenderness, engorgement, or milk production. However, the frequency and severity of these symptoms earlier in the second trimester (12-18 weeks) has not been well characterized.
Historically, medications such as bromocriptine were used to suppress lactation following pregnancy termination or delivery. However, bromocriptine has been associated with serious cardiovascular, neurologic, and psychiatric side effects and is no longer recommended for lactation suppression in the United States. Cabergoline, a dopamine agonist that suppresses prolactin secretion, has emerged as a safer alternative and has been shown to be effective in suppressing lactation after full-term delivery. More recent studies suggest that cabergoline may also reduce breast symptoms following abortion or pregnancy loss in the later second trimester, but limited evidence exists for individuals between 12 and 18 weeks of gestation.
This study aims to evaluate both the prevalence of breast symptoms and the effectiveness of cabergoline for preventing these symptoms among individuals undergoing abortion or pregnancy loss between 12 and 18 weeks of gestation.
The study will include two phases conducted at Maimonides Medical Center. In the first phase, participants will complete a survey assessing baseline breast symptoms prior to the abortion or pregnancy loss procedure. The survey will use the Bristol Breast Symptoms Inventory, a validated instrument that measures the severity of breast engorgement, milk leakage, tenderness, and the need for pain relief. This phase will allow researchers to estimate how frequently breast symptoms occur in this population.
In the second phase, participants will be enrolled in a double-blind randomized controlled trial. Participants will be randomly assigned to receive either a single oral dose of cabergoline (1 mg) or a placebo approximately one hour after the abortion or pregnancy loss procedure. Both participants and clinical providers will be blinded to the treatment assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Double-blinded (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant people aged 18 years or older
- •Gestational age between 12 and 18 weeks
- •Undergoing treatment for spontaneous or induced abortion at Maimonides Medical Center
- •Able to provide informed consent
- •Willing and able to complete study surveys
排除标准
- •Prior mastectomy
- •Currently breastfeeding
- •Current use of a dopamine agonist or dopamine antagonist medication
- •Known contraindication to Cabergoline according to the medication prescribing information
研究组 & 干预措施
Placebo
Participants undergoing abortion or pregnancy loss between 12 and 18 weeks of gestation will receive a single oral dose of placebo approximately one hour after the procedure. Participants will complete baseline and follow-up surveys assessing breast symptoms, including breast engorgement, milk leakage, tenderness, and need for pain relief, at multiple time points through 14 days after the procedure. A subset of participants may also provide blood samples for measurement of serum prolactin levels.
干预措施: Placebo (Drug)
Cabergoline
Participants undergoing abortion or pregnancy loss between 12 and 18 weeks of gestation will receive a single 1 mg oral dose of Cabergoline approximately one hour after the procedure. Participants will complete baseline and follow-up surveys assessing breast symptoms, including breast engorgement, milk leakage, tenderness, and need for pain relief, at multiple time points through 14 days after the procedure. A subset of participants may also provide blood samples for measurement of serum prolactin levels.
干预措施: Cabergoline (Drug)
结局指标
主要结局
Proportion of Participants With Breast Symptoms 4 Days After Abortion or Pregnancy Loss
时间窗: 4 days after abortion or pregnancy loss
The proportion of participants reporting any breast symptoms, including breast engorgement, milk leakage, tenderness, or need for pain relief, assessed using the Bristol Breast Symptoms Inventory.
次要结局
- Participant-Reported Bother/Satisfaction From Breast Symptoms & Serum Prolactin Levels(Days 0, 2, 3, 4, 7, and 14 after abortion or pregnancy loss)
研究者
Jefferson Drapkin
Research Manager
Maimonides Medical Center
