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口服地屈孕酮预防先兆流产致流产:一项随机、双盲、安慰剂对照试验。

Oral dydrogesterone for prevention of miscarriage in threatened miscarriage: a randomized, double-blind, placebo-controlled trial.

机构信息

Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Pathumwan, Bangkok, Thailand.

出版信息

J Matern Fetal Neonatal Med. 2024 Dec;37(1):2333929. doi: 10.1080/14767058.2024.2333929. Epub 2024 Apr 3.

DOI:10.1080/14767058.2024.2333929
PMID:38570191
Abstract

OBJECTIVE

To determine the effectiveness of oral dydrogesterone in preventing miscarriage in threatened miscarriage.

METHODS

A randomized, controlled trial study was conducted among pregnant Thai women at the gestational age of six to less than 20 weeks who visited King Chulalongkorn Memorial Hospital, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand with threatened miscarriage from August 2021 to August 2022. These pregnant women were randomized to receive oral dydrogesterone 20 mg per day or placebo twice a day until one week after vaginal bleeding stopped or otherwise for a maximum of six weeks.

RESULTS

A total of 100 pregnancies were recruited. Fifty of them were assigned to receive oral dydrogesterone and 50 were assigned to receive placebo. The rate of continuing pregnancy beyond 20 weeks of gestational age was 90.0% (45 out of 50 women) in the dydrogesterone group and 86.0% (43 out of 50 women) in the placebo group ( = 0.538). The incidence of adverse events did not differ significantly between the groups.

CONCLUSION

Oral dydrogesterone 20 mg/day could not prevent miscarriages in women with threatened miscarriage.

摘要

目的

评估口服地屈孕酮对先兆流产孕妇的保胎效果。

方法

一项随机对照试验在泰国曼谷朱拉隆功国王纪念医院妇产科进行,2021 年 8 月至 2022 年 8 月期间,招募了妊娠 6 周至 20 周加 6 天,有先兆流产表现的孕妇。这些孕妇被随机分配,每天口服地屈孕酮 20mg 或安慰剂,每天两次,直至阴道出血停止后一周,或最长使用 6 周。

结果

共有 100 例妊娠被招募。其中 50 例分配至地屈孕酮组,50 例分配至安慰剂组。地屈孕酮组中,妊娠继续至 20 周加 6 天以上的比例为 90.0%(45/50),安慰剂组为 86.0%(43/50)( = 0.538)。两组的不良事件发生率无显著差异。

结论

对于有先兆流产表现的孕妇,每天口服地屈孕酮 20mg 并不能预防流产。

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J Matern Fetal Neonatal Med. 2024 Dec;37(1):2333929. doi: 10.1080/14767058.2024.2333929. Epub 2024 Apr 3.
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Reprod Fertil. 2025 Feb 3;6(1). doi: 10.1530/RAF-24-0044. Print 2025 Jan 1.
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