即刻与延迟放置左炔诺孕酮宫内节育系统后牛奶中左炔诺孕酮水平和乳脂率的比较。
Comparison of levonorgestrel level and creamatocrit in milk following immediate versus delayed postpartum placement of the levonorgestrel IUD.
机构信息
The University of Utah School of Medicine, 30 N 1900 E, 2B200, Salt Lake City, UT, 84132, USA.
Department of Psychiatry, Neuropsychiatric Institute, University of Illinois, Chicago, 912 S Wood St, Chicago, IL, 60612, USA.
出版信息
BMC Womens Health. 2021 Jan 21;21(1):33. doi: 10.1186/s12905-021-01179-7.
BACKGROUND
Breastfeeding and postpartum contraception critically influence infant and maternal health outcomes. In this pilot study, we explore the effects of timing and duration of postpartum levonorgestrel exposure on milk lipid and levonorgestrel content to establish baseline data for future research.
METHODS
This sub-study recruited a balanced convenience sample from 259 participants enrolled in a parent randomized controlled trial comparing immediate to delayed (4-8 weeks) postpartum levonorgestrel IUD placement. All planned to breastfeed, self-selected for sub-study participation, and provided the first sample at 4-8 weeks postpartum (before IUD placement for the delayed group) and the second four weeks later. We used the Wilcoxon rank sum (inter-group) and signed rank (intra-group) tests to compare milk lipid content (creamatocrit) and levonorgestrel levels between groups and time points.
RESULTS
We recruited 15 participants from the immediate group and 17 from the delayed group with 10 and 12, respectively, providing both early and late samples. Initially, median levonorgestrel concentration of the immediate group (n = 10) (32.5 pg/mL, IQR: 24.8, 59.4) exceeded that of the delayed group (n = 12) (17.5 pg/mL, IQR: 0.0, 25.8) (p = 0.01). Four weeks later, the values aligned: 26.2 pg/mL (IQR: 20.3, 37.3) vs. 28.0 pg/mL (IQR: 25.2, 40.8). Creamatocrits were similar between both groups and timepoints.
CONCLUSIONS
Immediate postpartum levonorgestrel IUD placement results in steady, low levels of levonorgestrel in milk without apparent effects on lipid content. These findings provide initial support for the safety of immediate postpartum levonorgestrel IUD initiation, though the study was not powered to detect noninferiority between groups.
TRIAL REGISTRATION
This randomized controlled trial was registered with ClinicalTrials.gov (Registry No. NCT01990703) on November 21, 2013.
背景
母乳喂养和产后避孕对婴儿和产妇的健康结果有重要影响。在这项初步研究中，我们探讨了产后左炔诺孕酮暴露的时间和持续时间对乳汁脂质和左炔诺孕酮含量的影响，为未来的研究建立基线数据。
方法
这项子研究从参加一项比较即刻与延迟（4-8 周）产后左炔诺孕酮 IUD 放置的父母随机对照试验的 259 名参与者中招募了一个平衡的便利样本。所有参与者都计划母乳喂养，自行选择参加子研究，并在产后 4-8 周（延迟组 IUD 放置前）和四周后提供第一次样本。我们使用 Wilcoxon 秩和（组间）和符号秩（组内）检验比较组间和时间点的乳汁脂质含量（乳脂球计数）和左炔诺孕酮水平。
结果
我们从即刻组招募了 15 名参与者，从延迟组招募了 17 名参与者，其中 10 名和 12 名分别提供了早期和晚期样本。最初，即刻组（n=10）的左炔诺孕酮浓度中位数（32.5 pg/mL，IQR：24.8，59.4）高于延迟组（n=12）（17.5 pg/mL，IQR：0.0，25.8）（p=0.01）。四周后，两组的数值一致：26.2 pg/mL（IQR：20.3，37.3）与 28.0 pg/mL（IQR：25.2，40.8）。两组和两个时间点的乳脂球计数相似。
结论
即刻产后左炔诺孕酮 IUD 放置导致乳汁中左炔诺孕酮水平稳定且较低，而对脂质含量无明显影响。这些发现初步支持即刻产后左炔诺孕酮 IUD 启动的安全性，但该研究没有足够的能力来检测两组之间的非劣效性。
试验注册
这项随机对照试验于 2013 年 11 月 21 日在 ClinicalTrials.gov（注册号：NCT01990703）注册。
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