Planned early delivery versus expectant management to reduce adverse pregnancy outcomes in pre-eclampsia in a low- and middle-income setting: study protocol for a randomised controlled trial (CRADLE-4 Trial).
Planned early delivery versus expectant management to reduce adverse pregnancy outcomes in pre-eclampsia in a low- and middle-income setting: study protocol for a randomised controlled trial (CRADLE-4 Trial).
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DOI：
10.1186/s13063-020-04888-w
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发表时间：
2020-11-23
期刊：
影响因子：
2.5
通讯作者：
Shennan A
中科院分区：
文献类型：
--
作者：
Beardmore-Gray A;Vousden N;Charantimath U;Katageri G;Bellad M;Kapembwa K;Chinkoyo S;Vwalika B;Clark M;Hunter R;Seed P;Goudar S;Chappell LC;Shennan A
先兆子痫是一种妊娠并发症，其特征是母亲的高血压和多器官功能障碍。它是孕产妇和围产期死亡率的主要贡献者，其中99%的死亡发生在低收入和中等收入国家。虽然对于早发性(<； 34 Week)和足月型(≥ 37 Week)疾病的管理有明确的指南，但先兆子痫的最佳分娩时间在34+ 0和36+ 6周之间尚不清楚。在高收入环境下，分娩可能会在不损害婴儿的情况下改善产妇的结局，但这种干预措施尚未在LMIC中进行评估。CRODLE-4试验是一项非掩蔽随机对照试验，比较了印度和赞比亚妊娠34+ 0和36+ 6周的先兆子痫妇女的计划早期分娩(在随机化48 小时内开始分娩)和常规护理(期待治疗)。主要目标是确定有计划的早产政策是否可以在不增加严重新生儿发病率的情况下减少不良产妇结局。世界卫生组织建议所有患有先兆子痫的妇女从37 周起分娩，因为有证据表明，在不增加新生儿风险的情况下，孕妇有明显的益处。在34 周之前，谨慎等待是首选，由于早产有新生儿风险，只有在母亲或胎儿有严重危害时才建议分娩。目前，对于治疗34+ 0周至36+ 6周之间的先兆子痫的临床医生缺乏指导。早产对母亲有利，但可能会增加婴儿入院新生儿单元的需要(尽管在这一孕期没有严重的发病率)。另一方面，等待分娩可能会增加死产、胎儿生长受限和新生儿缺氧性脑损伤的风险，这是由于严重的母体并发症。对于不良事件发生率较高的LMIC来说，情况尤其如此。因此，在提出明确的建议之前，需要仔细评估风险和收益的平衡。这是第一次评估LMIC先兆子痫分娩最佳时机的试验，在那里，资源和疾病负担有很大不同。ISRCTN 10672137。注册日期为2019年11月28日。
Pre-eclampsia is a pregnancy complication characterised by high blood pressure and multi-organ dysfunction in the mother. It is a leading contributor to maternal and perinatal mortality, with 99% of these deaths occurring in low- and middle-income countries (LMIC). Whilst clear guidelines exist for management of early-onset (< 34 weeks) and term (≥ 37 weeks) disease, the optimal timing of delivery in pre-eclampsia between 34+ 0 and 36+ 6 weeks is less clear. In a high-income setting, delivery may improve maternal outcomes without detriment to the baby, but this intervention is yet to be evaluated in LMIC. The CRADLE-4 Trial is a non-masked, randomised controlled trial comparing planned early delivery (initiation of delivery within 48 h of randomisation) with routine care (expectant management) in women with pre-eclampsia between 34+ 0 and 36+ 6 weeks’ gestation in India and Zambia. The primary objective is to establish whether a policy of planned early delivery can reduce adverse maternal outcomes, without increasing severe neonatal morbidity. The World Health Organization recommends delivery for all women with pre-eclampsia from 37 weeks onwards, based on evidence showing clear maternal benefit without increased neonatal risk. Before 34 weeks, watchful waiting is preferred, with delivery recommended only when there is severe maternal or fetal compromise, due to the neonatal risks associated with early preterm delivery. Currently, there is a lack of guidance for clinicians managing women with pre-eclampsia between 34+ 0 and 36+ 6 weeks. Early delivery benefits the mother but may increase the need for neonatal unit admission in the infant (albeit without serious morbidity at this gestation). On the other hand, waiting to deliver may increase the risk of stillbirth, fetal growth restriction and hypoxic brain injury in the neonate as a result of severe maternal complications. This is especially true for LMIC where there is a higher prevalence of adverse events. The balance of risks and benefits therefore needs to be carefully assessed before making firm recommendations. This is the first trial evaluating the optimal timing of delivery in pre-eclampsia in LMIC, where resources and disease burden are considerably different. ISRCTN 10672137. Registered on 28 November 2019.
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