Obstetric Intensive Care Unit, Instituto de Medicina Integral Prof, Fernando Figueira, Recife, PE, Brazil.
Reprod Health. 2013 May 22;10:28. doi: 10.1186/1742-4755-10-28.
Hemolysis, elevated liver enzymes, and low platelets (HELLP) syndrome is one of the most severe forms of preeclampsia and aggravates both maternal and perinatal prognosis. The systematic review available in Cochrane Library compared corticosteroid (dexamethasone, betamethasone, or prednisolone) given during pregnancy, just after delivery or in the postnatal period, or both before and after birth, with placebo or no treatment. Those receiving steroids showed significantly greater improvement in platelet counts which was greater for those receiving dexamethasone than those receiving betamethasone. There was no clear evidence of any effect of corticosteroids on substantive clinical outcomes. These benefits appear to be greater in Class I HELLP syndrome.
To determine the effectiveness of dexamethasone for accelerating postpartum recovery in patients with Class I HELLP syndrome in a multicenter randomized controlled trial.
METHODS/DESIGN: The study is a triple blind randomized controlled trial including women with class I HELLP syndrome, and exclusion criteria were dexamethasone use in the last 15 days before diagnosis of HELLP syndrome; chronic use of corticosteroids; chronic diseases that alter laboratory parameters of HELLP Syndrome, such as chronic liver disease or purpura, patients unable to consent (coma or critical clinical condition) and without accompanying persons that may consent to study participation.Eligible patients will be invited to participate and those who agree will be included in the study and receive placebo or dexamethasone according to a random list of numbers and subjects will receive the study medication every 12 hours for two days.During the study the women will be subject to strict control of blood pressure and urine output. Laboratory tests will be performed at regular intervals during treatment and 24 hours and 48 hours after its suspension. If worsening of clinical or laboratory variables is observed, a rescue scheme of dexamethasone will be administrated. This proposal has already obtained approval of the local Institutional Review Board of the coordinating center (IMIP, Recife, Brazil), all other participating centers and of the National Council for Ethics in Research (CONEP) of the Brazilian Ministry of Health.
Clinical Trials Register under the number NCT00711841.
溶血、肝酶升高和血小板减少（HELLP）综合征是子痫前期最严重的形式之一，会加重母婴围生期的预后不良。Cochrane 图书馆中的系统评价比较了皮质类固醇（地塞米松、倍他米松或泼尼松龙）在怀孕期间、分娩后或产后给予，或两者均在产前和产后给予，与安慰剂或不治疗相比。接受类固醇治疗的患者血小板计数明显改善，接受地塞米松治疗的患者比接受倍他米松治疗的患者改善更明显。皮质类固醇对实质性临床结局的影响没有明确证据。这些益处似乎在 I 类 HELLP 综合征中更为明显。
在一项多中心随机对照试验中，确定地塞米松在加速 I 类 HELLP 综合征患者产后恢复方面的有效性。
方法/设计：这项研究是一项三盲随机对照试验，纳入了 I 类 HELLP 综合征患者，排除标准包括在诊断 HELLP 综合征前 15 天内使用地塞米松；长期使用皮质类固醇；改变 HELLP 综合征实验室参数的慢性疾病，如慢性肝病或紫癜，不能同意（昏迷或危急临床状况）且无陪同人员可能同意参与研究的患者。符合条件的患者将被邀请参加，同意参加的患者将被纳入研究，并根据随机数字列表接受安慰剂或地塞米松，受试者将每 12 小时接受研究药物治疗两天。在研究期间，将对女性的血压和尿量进行严格控制。在治疗过程中以及停止治疗后 24 小时和 48 小时，将定期进行实验室检查。如果观察到临床或实验室变量恶化，将给予地塞米松抢救方案。该方案已获得协调中心（巴西累西腓的 IMIP）、所有其他参与中心和巴西卫生部国家伦理委员会（CONEP）的当地机构审查委员会的批准。
临床试验注册编号 NCT00711841。
