Cluver Catherine, Novikova Natalia, Koopmans Corine M, West Helen M
Department of Obstetrics and Gynaecology, Faculty of Health Sciences, Stellenbosch University and Tygerberg Hospital, PO Box 19063, Tygerberg, Western Cape, South Africa, 7505.
Department of Obstetrics and Gynaecology, Faculty of Health Sciences, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa.
Cochrane Database Syst Rev. 2017 Jan 15;1(1):CD009273. doi: 10.1002/14651858.CD009273.pub2.
Hypertensive disorders in pregnancy are significant contributors to maternal and perinatal morbidity and mortality. These disorders include well-controlled chronic hypertension, gestational hypertension (pregnancy-induced hypertension) and mild pre-eclampsia. The definitive treatment for these disorders is planned early delivery and the alternative is to manage the pregnancy expectantly if severe uncontrolled hypertension is not present, with close maternal and fetal monitoring. There are benefits and risks associated with both, so it is important to establish the safest option.
To assess the benefits and risks of a policy of planned early delivery versus a policy of expectant management in pregnant women with hypertensive disorders, at or near term (from 34 weeks onwards).
We searched Cochrane Pregnancy and Childbirth Trials Register (12 January 2016) and reference lists of retrieved studies.
Randomised trials of a policy of planned early delivery (by induction of labour or by caesarean section) compared with a policy of delayed delivery ("expectant management") for women with hypertensive disorders from 34 weeks' gestation. Cluster-randomised trials would have been eligible for inclusion in this review, but we found none.Studies using a quasi-randomised design are not eligible for inclusion in this review. Similarly, studies using a cross-over design are not eligible for inclusion, because they are not a suitable study design for investigating hypertensive disorders in pregnancy.
Two review authors independently assessed eligibility and risks of bias. Two review authors independently extracted data. Data were checked for accuracy.
We included five studies (involving 1819 women) in this review.There was a lower risk of composite maternal mortality and severe morbidity for women randomised to receive planned early delivery (risk ratio (RR) 0.69, 95% confidence interval (CI) 0.57 to 0.83, two studies, 1459 women (evidence graded high)). There were no clear differences between subgroups based on our subgroup analysis by gestational age, gestational week or condition. Planned early delivery was associated with lower risk of HELLP syndrome (RR 0.40, 95% CI 0.17 to 0.93, 1628 women; three studies) and severe renal impairment (RR 0.36, 95% CI 0.14 to 0.92, 100 women, one study).There was not enough information to draw any conclusions about the effects on composite infant mortality and severe morbidity. We observed a high level of heterogeneity between the two studies in this analysis (two studies, 1459 infants, I = 87%, Tau = 0.98), so we did not pool data in meta-analysis. There were no clear differences between subgroups based on our subgroup analysis by gestational age, gestational week or condition. Planned early delivery was associated with higher levels of respiratory distress syndrome (RR 2.24, 95% CI 1.20 to 4.18, three studies, 1511 infants), and NICU admission (RR 1.65, 95% CI 1.13 to 2.40, four studies, 1585 infants).There was no clear difference between groups for caesarean section (RR 0.91, 95% CI 0.78 to 1.07, 1728 women, four studies, evidence graded moderate), or in the duration of hospital stay for the mother after delivery of the baby (mean difference (MD) -0.16 days, 95% CI -0.46 to 0.15, two studies, 925 women, evidence graded moderate) or for the baby (MD -0.20 days, 95% CI -0.57 to 0.17, one study, 756 infants, evidence graded moderate).Two fairly large, well-designed trials with overall low risk of bias contributed the majority of the evidence. Other studies were at low or unclear risk of bias. No studies attempted to blind participants or clinicians to group allocation, potentially introducing bias as women and staff would have been aware of the intervention and this may have affected aspects of care and decision-making.The level of evidence was graded high (composite maternal mortality and morbidity), moderate (caesarean section, duration of hospital stay after delivery for mother, and duration of hospital stay after delivery for baby) or low (composite infant mortality and morbidity). Where the evidence was downgraded, it was mostly because the confidence intervals were wide, crossing both the line of no effect and appreciable benefit or harm.
AUTHORS' CONCLUSIONS: For women suffering from hypertensive disorders of pregnancy after 34 weeks, planned early delivery is associated with less composite maternal morbidity and mortality. There is no clear difference in the composite outcome of infant mortality and severe morbidity; however, this is based on limited data (from two trials) assessing all hypertensive disorders as one group.Further studies are needed to look at the different types of hypertensive diseases and the optimal timing of delivery for these conditions. These studies should also include infant and maternal morbidity and mortality outcomes, caesarean section, duration of hospital stay after delivery for mother and duration of hospital stay after delivery for baby.An individual patient meta-analysis on the data currently available would provide further information on the outcomes of the different types of hypertensive disease encountered in pregnancy.
妊娠期高血压疾病是孕产妇和围产儿发病及死亡的重要原因。这些疾病包括控制良好的慢性高血压、妊娠期高血压(妊娠诱发的高血压)和轻度子痫前期。这些疾病的确定性治疗方法是计划早期分娩,若不存在严重的未控制高血压,则另一种选择是在密切监测母婴的情况下对妊娠进行期待治疗。两种方法都有其益处和风险,因此确定最安全的选择很重要。
评估对于孕晚期(34周及以后)患有高血压疾病的孕妇,计划早期分娩策略与期待治疗策略的益处和风险。
我们检索了Cochrane妊娠和分娩试验注册库(2016年1月12日)以及检索到的研究的参考文献列表。
将计划早期分娩(引产或剖宫产)策略与延迟分娩策略(“期待治疗”)进行比较的随机试验,受试对象为妊娠34周及以后患有高血压疾病的女性。整群随机试验本应符合纳入本综述的条件,但我们未找到此类试验。采用半随机设计的研究不符合纳入本综述的条件。同样,采用交叉设计的研究也不符合纳入条件,因为它们不是研究妊娠期高血压疾病的合适研究设计。
两位综述作者独立评估纳入资格和偏倚风险。两位综述作者独立提取数据。对数据的准确性进行了核对。
本综述纳入了五项研究(涉及1819名女性)。随机分配接受计划早期分娩的女性发生孕产妇综合死亡和严重发病的风险较低(风险比(RR)0.69,95%置信区间(CI)0.57至0.83,两项研究,1459名女性(证据等级为高))。根据我们按孕周、妊娠周数或病情进行的亚组分析,各亚组之间没有明显差异。计划早期分娩与发生HELLP综合征的风险较低相关(RR 0.40,95%CI 0.17至0.93,1628名女性;三项研究)以及严重肾功能损害的风险较低相关(RR 0.36,95%CI 0.14至0.92,100名女性,一项研究)。没有足够的信息来得出关于对婴儿综合死亡和严重发病影响的任何结论。在该分析中,我们观察到两项研究之间存在高度异质性(两项研究,1459名婴儿,I² = 87%,Tau² = 0.98),因此我们未在Meta分析中合并数据。根据我们按孕周、妊娠周数或病情进行的亚组分析,各亚组之间没有明显差异。计划早期分娩与呼吸窘迫综合征的发生率较高相关(RR 2.24,95%CI 1.20至4.18,三项研究,1511名婴儿),以及新生儿重症监护病房(NICU)入住率较高相关(RR 1.65,95%CI 1.13至2.40,四项研究,1585名婴儿)。剖宫产组之间没有明显差异(RR 0.91,95%CI 0.78至1.07,1728名女性,四项研究,证据等级为中等);或者婴儿出生后母亲的住院时间(平均差(MD)-0.16天,95%CI -0.46至0.15,两项研究,925名女性,证据等级为中等)或婴儿的住院时间(MD -0.20天,95%CI -0.57至0.17,一项研究,756名婴儿,证据等级为中等)。两项规模较大、设计良好且总体偏倚风险较低的试验提供了大部分证据。其他研究的偏倚风险较低或不明确。没有研究试图对参与者或临床医生隐瞒分组情况,这可能会引入偏倚,因为女性和工作人员会知晓干预措施,这可能会影响护理和决策的各个方面。证据等级为高(孕产妇综合死亡和发病)、中等(剖宫产、婴儿出生后母亲的住院时间以及婴儿的住院时间)或低(婴儿综合死亡和发病)。当证据被降级时,主要是因为置信区间较宽,跨越了无效应线以及明显的益处或危害线。
对于34周后患有妊娠期高血压疾病的女性,计划早期分娩与较低的孕产妇综合发病和死亡率相关。婴儿死亡和严重发病的综合结局没有明显差异;然而,这是基于将所有高血压疾病作为一组评估的有限数据(来自两项试验)。需要进一步研究不同类型高血压疾病以及这些情况下的最佳分娩时机。这些研究还应包括婴儿和孕产妇的发病和死亡结局、剖宫产、婴儿出生后母亲的住院时间以及婴儿的住院时间。对现有数据进行个体患者Meta分析将提供关于妊娠期遇到的不同类型高血压疾病结局的更多信息。