胎膜早破患者应用抗生素预防感染：一项前瞻性、多中心、随机试验。
Antibiotic prophylaxis in ragged placental membranes: a prospective, multicentre, randomized trial.
机构信息
Department of Obstetrics and Gynaecology, Sarawak General Hospital, Hospital Road, 93586, Kuching, Sarawak, Malaysia.
Department of Obstetrics and Gynaecology, Sri Aman Hospital, Hospital Road, 95000, Sri Aman, Sarawak, Malaysia.
出版信息
BMC Pregnancy Childbirth. 2019 Jul 11;19(1):240. doi: 10.1186/s12884-019-2373-9.
BACKGROUND
Ragged placental membranes is a distinct entity from retained placenta and not uncommonly reported in midwifery texts. Although the incidence of postpartum endometritis is merely 1-5% after vaginal births, it remains the most common source of puerperal sepsis, contributing up to 15% of maternal mortality in low income countries. Geographically-remote centres in Malaysia prophylactically administer antibiotics for women with ragged placental membranes after vaginal birth, extrapolating evidence from retained placenta. We sought to clarify the rationale in continuing such practices.
METHODS
This was an open-label, prospective, multicentre, randomized trial. Three hospitals where the current protocol was to administer prophylactic amoxycillin-clavulanic acid served as the sites of recruitment. Women who delivered vaginally beyond 24 weeks of gestation with ragged membranes were invited to participate in the trial and randomized into prophylaxis or expectant management with medical advice by blocks of 10, at a 1:1 ratio. A medication adherence diary was provided and patients followed up at 2 weeks and 6 weeks postpartum.
RESULTS
A total of 6569 women gave birth vaginally in three centres during the trial period, of which 10.9% had ragged membranes. The incidence of endometritis was not significantly raised in women with or without prophylaxis (0.90% vs 0.29%; p = 0.60). All cases of endometritis presented within the first 2 weeks and preventive use of antibiotics did not ameliorate the severity of endometritis since rates of ICU admission, surgical evacuation and transfusion were comparable.
CONCLUSION
Preventive use of antibiotics after vaginal delivery in women with ragged placental membranes did not result in a reduction of endometritis. Educating women on the signs and symptoms of endometritis would suffice. Based on the reported incidence of ragged membranes, a change in practice would result in 1500 less prescriptions of antibiotics per annum in these three centres.
TRIAL REGISTRATION
NCT03459599 (Retrospectively registered on 9 March 2018).
背景
胎盘边缘不规则是一种与胎盘滞留不同的实体，在助产士文献中常有报道。虽然阴道分娩后子宫内膜炎的发病率仅为 1-5%，但它仍然是产褥期脓毒症最常见的来源，在低收入国家占产妇死亡的 15%。马来西亚地理位置偏远的中心对阴道分娩后胎盘边缘不规则的妇女预防性使用抗生素，这是从胎盘滞留中推断出的证据。我们试图澄清继续这种做法的理由。
方法
这是一项开放性、前瞻性、多中心、随机试验。三个医院采用当前方案为阴道分娩后胎盘边缘不规则的妇女预防性使用阿莫西林-克拉维酸，作为招募地点。邀请在妊娠 24 周后阴道分娩且胎盘边缘不规则的妇女参加试验，并按 10 例为一组，以 1:1 的比例随机分为预防组或接受医学建议的期待治疗组。提供了一份药物依从性日记，并在产后 2 周和 6 周对患者进行随访。
结果
在试验期间，三个中心共有 6569 名妇女阴道分娩，其中 10.9%有胎盘边缘不规则。预防性使用抗生素不会增加有或没有预防性使用抗生素的妇女的子宫内膜炎发生率（0.90%比 0.29%；p=0.60）。所有子宫内膜炎病例均在产后 2 周内出现，预防性使用抗生素并不能改善子宫内膜炎的严重程度，因为 ICU 入院、手术清除和输血的比例相当。
结论
在胎盘边缘不规则的阴道分娩妇女中预防性使用抗生素不会降低子宫内膜炎的发生率。对妇女进行有关子宫内膜炎的症状和体征的教育就足够了。根据报告的胎盘边缘不规则发生率，这三个中心每年将减少 1500 例抗生素处方。
试验注册
NCT03459599（于 2018 年 3 月 9 日回顾性注册）。
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