Risk of infection and wound dehiscence after use of prophylactic antibiotics in episiotomy or second degree tear (REPAIR study): single centre, double blind, placebo controlled randomised trial.

Methods

Single centre, double blind, placebo controlled randomised trial.

单中心、双盲、安慰剂对照的随机试验。

One university hospital in the Capital Region of Denmark.

位于丹麦首都地区的某大学医院。

Participants were enrolled between March and December 2023.

参与者在2023年3月至12月期间被纳入研究。

All initial clinical consultations were conducted between March 2023 and January 2024, and all long term follow-up consultations were conducted between March and November 2024.

所有初始临床咨询均在2023年3月至2024年1月之间进行，所有长期随访咨询均在2024年3月至11月之间进行。

This article reports only data from the first consultation.

本文仅报告了首次咨询的数据。

442 women with episiotomies or second degree tears were consecutively recruited at delivery.

在分娩时，连续招募了442名有会阴切开术或二度撕裂的女性。

Exclusion criteria included treatment allergy (or risk of cross reactivity with related antibiotics), antibiotic use within 24 hours of delivery, non-Danish speakers, caesarean section, or episiotomy extension.

排除标准包括治疗过敏（或与相关抗生素交叉反应的风险）、分娩前24小时内使用抗生素、非丹麦语使用者、剖宫产或会阴切开术延长。

intervention

A computer generated program randomised participants to either three doses of amoxicillin (500 mg) with clavulanic acid (125 mg) or placebo starting within six hours post partum and repeated at eight hour intervals.

计算机生成的程序将参与者随机分配到三剂量的阿莫西林（500毫克）与克拉维酸（125毫克）或安慰剂组，开始于产后六小时内，并以八小时间隔重复。

Follow-up was conducted four to 14 days post partum.

随访在产后4至14天进行。

Physicians, the steering committee, and participants were blinded.

医生、指导委员会成员以及参与者均被蒙蔽。

Methods

Wound complications (primary outcome) and clinically relevant wound complications (secondary outcome).

伤口并发症（主要结果）和临床上相关的伤口并发症（次要结果）。

Results

The study ended as planned, in December 2024. 433 women completed follow-up and were included in the primary analysis.

研究按计划在2024年12月结束。433名女性完成了随访，并被纳入主要分析。

No significant difference was observed in overall wound complications (antibiotic 47/218, 22%; placebo 62/215, 29%; P=0.10), with a risk difference of -7.2% (95% confidence interval(CI) -15.4% to 0.8%) and a relative risk of 0.75 (0.54 to 1.04).

在总体伤口并发症方面未观察到显著差异（抗生素组47/218，22%；安慰剂组62/215，29%；P=0.10），风险差异为-7.2%（95%置信区间（CI）-15.4%至0.8%），相对风险为0.75（0.54至1.04）。

For clinically relevant wound complications, significantly fewer events occurred in the treatment group (19/218, 9% v 36/215, 17%; P=0.01), with a risk difference of -8.0% (95% CI -14.3% to -1.8%) and a relative risk of 0.52 (0.31 to 0.88).

在临床相关伤口并发症方面，治疗组发生事件显著较少（19/218，9%对比36/215，17%；P=0.01），风险差异为-8.0%（95%置信区间-14.3%至-1.8%），相对风险为0.52（0.31至0.88）。

For clinically relevant wound complications, the number needed to treat was 12 (95% CI 7 to 56).

在临床相关伤口并发症方面，需要治疗的患者数为12（95%置信区间7至56）。

Exploratory outcomes show that the treatment group reported better self-evaluated health, received fewer additional antibiotic treatments, and had smaller average wound dehiscence among patients with dehiscence.

探索性结果表明，治疗组报告了更好的自我评估健康状况，接受了更少的额外抗生素治疗，并且在有伤口裂开的患者中，平均伤口裂开程度较小。

No serious adverse reactions occurred.

没有发生严重的不良反应。

Conclusions

Although no significant effect was seen for overall wound complications, prophylactic antibiotics significantly reduced the risk of clinically relevant wound complications in women with episiotomies and second degree tears and should be considered in postpartum care.

尽管对于总体伤口并发症没有显著效果，但预防性抗生素显著降低了有会阴切开和二度撕裂的妇女的临床相关伤口并发症风险，应在产后护理中予以考虑。

trial_registration

Clinical Trials Information System (euclinicaltrials.eu) 2022-501930-49-00 and ClinicalTrials.gov NCT05830162.

临床试验信息系统(euclinicaltrials.eu) 2022-501930-49-00 和 ClinicalTrials.gov NCT05830162。