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采用血清孕激素作为有先兆流产风险患者管理指导的新方法:一项前瞻性队列研究。

Novel approach using serum progesterone as a triage to guide management of patients with threatened miscarriage: a prospective cohort study.

机构信息

Department of Obstetrics and Gynaecology, KK Women's and Children's Hospital, 100 Bukit Timah Road, 229899, Singapore, Singapore.

Duke-National University of Singapore Medical School, 8 College Road, 169857, Singapore, Singapore.

出版信息

Sci Rep. 2020 Jun 4;10(1):9153. doi: 10.1038/s41598-020-66155-x.

DOI:10.1038/s41598-020-66155-x
PMID:32499581
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7272626/
Abstract

Threatened miscarriage is a common gynaecological emergency, with up to 25% of women eventually progressing to spontaneous miscarriage. The uncertainty of pregnancy outcomes results in significant anxiety. However, there is currently no acceptable framework for triaging patients presenting with threatened miscarriage. We aim to evaluate the efficacy and safety of a novel clinical protocol using a single serum progesterone level to prognosticate and guide management of patients with threatened miscarriage. 1087 women presenting with threatened miscarriage were enrolled in the study. The primary outcome was spontaneous miscarriage by 16 weeks' gestation. Among the 77.9% (847/1087) of study participants with serum progesterone ≥ 35 nmol/L who were not treated with oral dydrogesterone, the miscarriage rate was 9.6% (81/847). This did not differ significantly from the 8.5% (31/364) miscarriage rate observed in our prior studies; p = 0.566. Among women with serum progesterone < 35 nmol/L who were treated with dydrogesterone, the miscarriage rate was 70.8% (170/240). Our novel clinical triage protocol using a single serum progesterone level allowed both effective risk stratification and a reduction in progestogen use with no significant adverse pregnancy outcomes. This protocol, based on a single serum progesterone cutoff, can be readily adapted for use in other healthcare institutions.

摘要

先兆流产是一种常见的妇科急症,多达 25%的女性最终会自然流产。妊娠结局的不确定性导致了明显的焦虑。然而,目前对于有先兆流产症状的患者的分诊还没有一个可接受的框架。我们旨在评估一种使用单一血清孕激素水平预测和指导先兆流产患者管理的新型临床方案的疗效和安全性。共有 1087 名有先兆流产症状的妇女参与了这项研究。主要结局是 16 周时自发流产。在未接受口服地屈孕酮治疗、血清孕激素水平≥35 nmol/L 的 77.9%(847/1087)研究参与者中,流产率为 9.6%(81/847)。与我们之前研究中观察到的 8.5%(31/364)的流产率相比,这没有显著差异;p=0.566。在接受地屈孕酮治疗、血清孕激素水平<35 nmol/L 的妇女中,流产率为 70.8%(170/240)。我们使用单一血清孕激素水平的新型临床分诊方案,既能有效进行风险分层,又能减少孕激素的使用,且妊娠结局无显著不良。该方案基于单一的血清孕激素截断值,可以很容易地在其他医疗机构中应用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0dc/7272626/2765c4ca54c3/41598_2020_66155_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0dc/7272626/aec7068dcc8b/41598_2020_66155_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0dc/7272626/2765c4ca54c3/41598_2020_66155_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0dc/7272626/aec7068dcc8b/41598_2020_66155_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0dc/7272626/2765c4ca54c3/41598_2020_66155_Fig2_HTML.jpg

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本文引用的文献

1
A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy.一项孕激素治疗早孕期出血患者的随机临床试验。
N Engl J Med. 2019 May 9;380(19):1815-1824. doi: 10.1056/NEJMoa1813730.
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Serum progesterone distribution in normal pregnancies compared to pregnancies complicated by threatened miscarriage from 5 to 13 weeks gestation: a prospective cohort study.比较 5 至 13 孕周正常妊娠与因先兆流产而复杂的妊娠的血清孕激素分布:一项前瞻性队列研究。
BMC Pregnancy Childbirth. 2018 Sep 5;18(1):360. doi: 10.1186/s12884-018-2002-z.
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Progestogen for treating threatened miscarriage.
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The threshold effect of factors associated with spontaneous abortion in human-assisted reproductive technology.与人类辅助生殖技术中自然流产相关因素的阈值效应。
Sci Rep. 2021 May 31;11(1):11368. doi: 10.1038/s41598-021-90970-5.
用于治疗先兆流产的孕激素。
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Threatened miscarriage and depressive and anxiety symptoms among women and partners in early pregnancy.孕早期孕妇及其伴侣的难免流产威胁与抑郁焦虑症状。
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[Risk factors for different types of hypospadias].[不同类型尿道下裂的危险因素]
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The Influence of Oral Dydrogesterone and Vaginal Progesterone on Threatened Abortion: A Systematic Review and Meta-Analysis.口服地屈孕酮和阴道用孕酮对先兆流产的影响:系统评价和荟萃分析。
Biomed Res Int. 2017;2017:3616875. doi: 10.1155/2017/3616875. Epub 2017 Dec 17.
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Dydrogesterone use in early pregnancy.孕早期使用地屈孕酮。
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