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COHELLP: collaborative randomized controlled trial on corticosteroids in HELLP syndrome

机译：COHELLP：HELLP综合征中糖皮质激素的协作随机对照试验

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Background 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. Objectives 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. Trial Registration Clinical Trials Register under the number NCT00711841 .
机译：背景溶血，肝酶升高和低血小板（HELLP）综合征是先兆子痫最严重的形式之一，并加重了母亲和围产期的预后。 Cochrane Library中提供的系统评价比较了妊娠期，分娩后或产后或出生前和分娩后使用安慰剂或未治疗的皮质类固醇（地塞米松，倍他米松或泼尼松龙）。接受类固醇激素治疗的人的血小板计数明显改善，与接受倍他米松治疗的患者相比，接受地塞米松治疗的患者血小板计数的改善更大。没有明确的证据表明皮质类固醇对实质性临床结局有任何影响。在I类HELLP综合征中，这些益处似乎更大。目的在一项多中心随机对照试验中确定地塞米松对I类HELLP综合征患者加速产后恢复的有效性。方法/设计本研究是一项三盲随机对照试验，包括患有I类HELLP综合征的女性，排除标准为诊断为HELLP综合征前的最后15天使用地塞米松。长期使用皮质类固醇;会改变HELLP综合征实验室参数的慢性疾病，例如慢性肝病或紫癜，无法同意（昏迷或危急的临床状况）且未经陪同人员同意参加研究的患者。将邀请符合条件的患者参加，同意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，并且受试者将每两小时接受研究药物，为期两天。在研究过程中，妇女将受到严格控制的血压和尿量。在治疗期间以及暂停后24小时和48小时，应定期进行实验室测试。如果观察到临床或实验室变量恶化，将实施地塞米松挽救方案。该提案已获得协调中心（IMIP，巴西累西腓），所有其他参与中心以及巴西卫生部国家伦理研究理事会（CONEP）当地机构审查委员会的批准。试验注册临床试验注册编号为NCT00711841。

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