Department of Obstetrics and Gynecology, Family Planning Services and Research Section, Stanford University School of Medicine, Palo Alto, California; and DuPont Clinic, Washington, DC.
Obstet Gynecol. 2023 Jun 1;141(6):1115-1123. doi: 10.1097/AOG.0000000000005190. Epub 2023 May 3.
To assess cabergoline's efficacy at decreasing breast symptoms after second-trimester abortion or pregnancy loss.
This was a double-blinded, block-randomized superiority trial comparing cabergoline 1 mg once to placebo for preventing bothersome breast engorgement after second-trimester uterine evacuation. We enrolled pregnant people at 18-28 weeks of gestation who were English- or Spanish-speaking and without contraindication to the study drug. Participants completed a validated, piloted, electronic survey at baseline and at multiple timepoints through 2 weeks postprocedure to assess breast symptoms, side effects, and bother. Our primary outcome was any breast symptoms (a composite of engorgement, milk leakage, tenderness, and need for pain relief) on day 4; we planned to enroll 80 patients to show a 30% difference in breast symptoms (80% power, α=0.049). A subgroup of participants returned for serum prolactin levels.
After screening 150 patients from April 2021 to June 2022, we enrolled 73 participants. Baseline demographics were balanced between groups: median gestational age was 21 weeks (range 18-26 weeks), 56.2% of participants were nulliparous, 34.2% self-identified as Hispanic, and 37.0% had public insurance. At baseline, reported breast symptoms were similar between groups. Among 69 participants who returned surveys on day 4, significantly fewer participants receiving cabergoline reported any breast symptoms compared with placebo (27.8% vs 97.0%, P<.001) (primary outcome) and fewer reported significant bother (2.8% vs 33.3%, P=.001) (secondary outcome). These differences persisted through day 14. Reported incidence and severity of bother from side effects were similar between groups: most common were constipation, fatigue, and headache. Serum prolactin levels were similar at baseline. On day 4, mean serum prolactin level was 6.5 ng/mL (SD 2.2) for those who received cabergoline and 18.0 ng/mL (SD 5.9) for placebo (P=.049).
Cabergoline is an effective and well-tolerated strategy to prevent breast symptoms after second-trimester abortion or pregnancy loss.
ClinicalTrials.gov, NCT04701333.
评估卡麦角林在减少中期妊娠流产或妊娠丢失后乳房症状的疗效。
这是一项双盲、随机分组的优效性试验，比较卡麦角林 1mg 一次与安慰剂用于预防中期子宫排空后烦人的乳房充盈。我们招募了 18-28 孕周的妊娠患者，他们会讲英语或西班牙语，并且对研究药物无禁忌。参与者在基线和术后 2 周内的多个时间点完成了一项经过验证的、试点的电子调查，以评估乳房症状、副作用和困扰。我们的主要结局是第 4 天的任何乳房症状（充盈、溢乳、触痛和需要缓解疼痛的复合症状）；我们计划招募 80 名患者，以显示乳房症状有 30%的差异（80%的效力，α=0.049）。一组参与者返回进行血清催乳素水平检测。
在 2021 年 4 月至 2022 年 6 月期间筛查了 150 名患者后，我们招募了 73 名参与者。两组的基线人口统计学特征平衡：中位孕龄为 21 周（范围 18-26 周），56.2%的参与者为初产妇，34.2%自认为是西班牙裔，37.0%有公共保险。在基线时，两组的报告乳房症状相似。在 69 名返回第 4 天调查的参与者中，与安慰剂相比，接受卡麦角林治疗的参与者报告任何乳房症状的比例显著更低（27.8%比 97.0%，P<.001）（主要结局），报告显著困扰的比例也更低（2.8%比 33.3%，P=.001）（次要结局）。这些差异在第 14 天仍持续存在。两组报告的副作用引起的困扰发生率和严重程度相似：最常见的是便秘、疲劳和头痛。基线时血清催乳素水平相似。在第 4 天，接受卡麦角林治疗的患者平均血清催乳素水平为 6.5ng/mL（SD 2.2），而接受安慰剂的患者为 18.0ng/mL（SD 5.9）（P=.049）。
卡麦角林是一种有效且耐受良好的策略，可预防中期妊娠流产或妊娠丢失后乳房症状。
ClinicalTrials.gov，NCT04701333。
