Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Number of Participants Reporting Breast Pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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, 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
排除标准
- •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
- •Exclusion Criteria:
- •Prior mastectomy (breast reduction or chest masculinization surgery acceptable)
- •Currently breastfeeding
- •Currently receiving dopamine agonist or antagonist therapy for other indication leg syndrome)
- •Contraindication to cabergoline (as per package insert)
- •Uncontrolled hypertension - defined as baseline BP > 160/110, or chronic hypertension requiring more than one baseline medication, or current pregnancy-induced hypertension spectrum disorders (gestational hypertension, preeclampsia, eclampsia)
- •History of cardiac valvular disorders or valvular repair
- •History of pulmonary, pericardial, or retroperitoneal fibrotic disorders
研究组 & 干预措施
Cabergoline
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.
干预措施: Cabergoline 1 MG (Drug)
Placebo
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Reporting Breast Pain
时间窗: 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.
次要结局
- Number of Participants Experiencing Side-effects(Cumulative over 2 weeks)
- Number of Participants Reporting Significant Bother From Breast Pain(Day 4 after procedure)
- Number of Participants Reporting Significant Bother From Side-effects(Cumulative over 2 weeks)