Department of Obstetrics and Gynecology, Maastricht University Medical Centre, GROW-School for Oncology and Developmental Biology, The Netherlands.
BMC Pregnancy Childbirth. 2011 Jul 7;11:50. doi: 10.1186/1471-2393-11-50.
Gestational hypertension (GH) and pre-eclampsia (PE) can result in severe complications such as eclampsia, placental abruption, syndrome of Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP) and ultimately even neonatal or maternal death. We recently showed that in women with GH or mild PE at term induction of labour reduces both high risk situations for mothers as well as the caesarean section rate. In view of this knowledge, one can raise the question whether women with severe hypertension, pre-eclampsia or deterioration chronic hypertension between 34 and 37 weeks of gestation should be delivered or monitored expectantly. Induction of labour might prevent maternal complications. However, induction of labour in late pre-term pregnancy might increase neonatal morbidity and mortality compared with delivery at term.
METHODS/DESIGN: Pregnant women with severe gestational hypertension, mild pre-eclampsia or deteriorating chronic hypertension at a gestational age between 34+0 and 36+6 weeks will be asked to participate in a multi-centre randomised controlled trial. Women will be randomised to either induction of labour or expectant monitoring. In the expectant monitoring arm, women will be induced only when the maternal or fetal condition detoriates or at 37+0 weeks of gestation. The primary outcome measure is a composite endpoint of maternal mortality, severe maternal complications (eclampsia, HELLP syndrome, pulmonary oedema and thromboembolic disease) and progression to severe pre-eclampsia. Secondary outcomes measures are respiratory distress syndrome (RDS), neonatal morbidity and mortality, caesarean section and vaginal instrumental delivery rates, maternal quality of life and costs. Analysis will be intention to treat. The power calculation is based on an expectant reduction of the maternal composite endpoint from 5% to 1% for an expected increase in neonatal RDS from 1% at 37 weeks to 10% at 34 weeks. This implies that 680 women have to be randomised.
This trial will provide insight as to whether in women with hypertensive disorders late pre-term, induction of labour is an effective treatment to prevent severe maternal complications without compromising the neonatal morbidity.
NTR1792 CLINICAL TRIAL REGISTRATION: http://www.trialregister.nl.
妊娠高血压（GH）和子痫前期（PE）可导致严重并发症，如子痫、胎盘早剥、溶血、肝酶升高和血小板减少（HELLP）综合征，最终甚至导致新生儿或产妇死亡。我们最近发现，对于足月时患有 GH 或轻度 PE 的妇女，引产可降低母婴高危情况和剖宫产率。鉴于这一知识，人们不禁要提出这样一个问题，即患有严重高血压、子痫前期或慢性高血压恶化的孕妇在 34 至 37 孕周之间是否应该分娩或期待治疗。引产可能可以预防产妇并发症。然而，与足月分娩相比，晚期早产引产可能会增加新生儿发病率和死亡率。
方法/设计：将邀请患有严重妊娠期高血压、轻度子痫前期或在 34+0 至 36+6 孕周之间慢性高血压恶化的孕妇参加一项多中心随机对照试验。这些孕妇将被随机分为引产或期待监测组。在期待监测组中，只有当孕妇或胎儿情况恶化时，或在 37+0 孕周时，才会进行引产。主要结局指标是产妇死亡率、严重产妇并发症（子痫、HELLP 综合征、肺水肿和血栓栓塞性疾病）和进展为重度子痫前期的复合终点。次要结局指标是呼吸窘迫综合征（RDS）、新生儿发病率和死亡率、剖宫产率和阴道器械分娩率、产妇生活质量和成本。分析将采用意向治疗。该计算是基于在期待治疗中，将严重产妇复合终点从 5%降低至 1%，而在 34 孕周时，新生儿 RDS 从 1%增加至 10%的预期值。这意味着需要随机分配 680 名妇女。
该试验将提供证据，证明在患有高血压疾病的孕妇中，晚期早产引产是否是一种有效的治疗方法，可以预防严重的产妇并发症，而不影响新生儿发病率。
NTR1792 临床试验注册：http://www.trialregister.nl。
