Ashworth Danielle C, Maule Sophie P, Stewart Fiona, Nathan Hannah L, Shennan Andrew H, Chappell Lucy C
Department of Women and Children's Health, King's College London, London, UK.
Cochrane Children and Families Network, c/o Cochrane Pregnancy and Childbirth, Department of Women's and Children's Health, The University of Liverpool, Liverpool, UK.
Cochrane Database Syst Rev. 2020 Jul 23;8(8):CD012739. doi: 10.1002/14651858.CD012739.pub2.
Regular blood pressure (BP) measurement is crucial for the diagnosis and management of hypertensive disorders in pregnancy, such as pre-eclampsia. BP can be measured in various settings, such as conventional clinics or self-measurement at home, and with different techniques, such as using auscultatory or automated BP devices. It is important to understand the impact of different settings and techniques of BP measurement on important outcomes for pregnant women.
To assess the effects of setting and technique of BP measurement for diagnosing hypertensive disorders in pregnancy on subsequent maternal and perinatal outcomes, women's quality of life, or use of health service resources.
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) on 22 April 2020, and reference lists of retrieved studies.
Randomised controlled trials (RCTs) involving pregnant women, using validated BP devices in different settings or using different techniques.
Two authors independently extracted data, assessed risk of bias, and used the GRADE approach to assess the certainty of the evidence.
Of the 21 identified studies, we included three, and excluded 11; seven were ongoing. Of the three included RCTs (536,607 women), one was a cluster-RCT, with a substantially higher number of participants (536,233 deliveries) than the other two trials, but did not provide data for most of our outcomes. We generally judged the included studies at low risk of bias, however, the certainty of the evidence was low, due to indirectness and imprecision. Meta-analysis was not possible because each study investigated a different comparison. None of the included studies reported our primary outcome of systolic BP greater than or equal to 150 mmHg. None of the studies reported any of these important secondary outcomes: antenatal hospital admissions, neonatal unit length of stay, or neonatal endotracheal intubation and use of mechanical ventilation. Setting of BP measurement: self-measurement versus conventional clinic measurement (one study, 154 women) There were no maternal deaths in either the self-monitoring group or the usual care group. The study did not report perinatal mortality. Self-monitoring may lead to slightly more diagnoses of pre-eclampsia compared with usual care (risk ratio (RR) 1.49, 95% confidence interval (CI) 0.87 to 2.54; 154 women; 1 study; low-certainty evidence) but the wide 95% CI is consistent with possible benefit and possible harm. Self-monitoring may have little to no effect on the likelihood of induction of labour compared with usual care (RR 1.09, 95% CI 0.82 to 1.45; 154 women; 1 study; low-certainty evidence). We are uncertain if self-monitoring BP has any effect on maternal admission to intensive care (RR 1.54, 95% CI 0.06 to 37.25; 154 women; 1 study; low-certainty evidence), stillbirth (RR 2.57, 95% CI 0.13 to 52.63; 154 women; 1 study; low-certainty evidence), neonatal death (RR 1.54, 95% CI 0.06 to 37.25; 154 women; 1 study; low-certainty evidence) or preterm birth (RR 1.15, 95% CI 0.37 to 3.55; 154 women; 1 study; low-certainty evidence), compared with usual care because the certainty of evidence is low and the 95% CI is consistent with appreciable harms and appreciable benefits. Self-monitoring may lead to slightly more neonatal unit admissions compared with usual care (RR 1.53, 95% CI 0.65 to 3.62; 154 women; 1 study; low-certainty evidence) but the wide 95% CI includes the possibility of slightly fewer admissions with self-monitoring. Technique of BP measurement: Korotkoff phase IV (K4, muffling sound) versus Korotkoff phase V (K5, disappearance of sound) to represent diastolic BP (one study, 220 women) There were no maternal deaths in either the K4 or K5 group. There may be little to no difference in the diagnosis of pre-eclampsia between using K4 or K5 for diastolic BP (RR 1.16; 95% CI 0.89 to 1.49; 1 study; 220 women; low-certainty evidence), since the wide 95% CI includes the possibility of more diagnoses with K4. We are uncertain if there is a difference in perinatal mortality between the groups because the quality of evidence is low and the 95% CI is consistent with appreciable harm and appreciable benefit (RR 1.14, 95% CI 0.16 to 7.92; 1 study, 220 women; low-certainty evidence). The trial did not report data on maternal admission to intensive care, induction of labour, stillbirth, neonatal death, preterm birth, or neonatal unit admissions. Technique of BP measurement: CRADLE intervention (CRADLE device, a semi-automated BP monitor with additional features, and an education package) versus usual care (one study, 536,233 deliveries) There may be little to no difference between the use of the CRADLE device and usual care in the number of maternal deaths (adjusted RR 0.80, 95% CI 0.30 to 2.11; 536,233 women; 1 study; low-certainty evidence), but the 95% CI is consistent with appreciable harm and appreciable benefit. The trial did not report pre-eclampsia, induction of labour, perinatal mortality, preterm birth, or neonatal unit admissions. Maternal admission to intensive care and perinatal outcomes (stillbirths and neonatal deaths) were only collected for a small proportion of the women, identified by an outcome not by baseline characteristics, thereby breaking the random allocation. Therefore, any differences between the groups could not be attributed to the intervention, and we did not extract data for these outcomes.
AUTHORS' CONCLUSIONS: The benefit, if any, of self-monitoring BP in hypertensive pregnancies remains uncertain, as the evidence is limited to one feasibility study. Current practice of using K5 to measure diastolic BP is supported for women with pregnancy hypertension. The benefit, if any, of using the CRADLE device to measure BP in pregnancy remains uncertain, due to the limitations and instability of the trial study design.
定期测量血压对于妊娠期高血压疾病(如子痫前期)的诊断和管理至关重要。血压可以在各种环境中测量,如传统诊所或在家自我测量,并且可以使用不同的技术,如使用听诊法或自动血压测量设备。了解不同的血压测量环境和技术对孕妇重要结局的影响很重要。
评估血压测量环境和技术对妊娠期高血压疾病诊断的影响,以及对随后的孕产妇和围产期结局、妇女生活质量或卫生服务资源利用的影响。
我们于2020年4月22日检索了Cochrane妊娠与分娩试验注册库、ClinicalTrials.gov、世界卫生组织国际临床试验注册平台(ICTRP)以及检索到的研究的参考文献列表。
涉及孕妇的随机对照试验(RCT),在不同环境中使用经过验证的血压测量设备或使用不同技术。
两位作者独立提取数据、评估偏倚风险,并使用GRADE方法评估证据的确定性。
在识别出的21项研究中,我们纳入了3项,排除了11项;7项正在进行中。在纳入的3项RCT(536,607名女性)中,1项为整群RCT,参与者数量(536,233例分娩)比其他两项试验多得多,但未提供我们大多数结局的数据。我们总体上判断纳入的研究偏倚风险较低,然而,由于证据的间接性和不精确性,证据的确定性较低。由于每项研究调查的是不同的比较,因此无法进行荟萃分析。纳入的研究均未报告我们的主要结局,即收缩压大于或等于150 mmHg。没有研究报告任何这些重要的次要结局:产前住院、新生儿住院时间、新生儿气管插管和机械通气的使用。血压测量环境:自我测量与传统诊所测量(1项研究,154名女性)自我监测组和常规护理组均无孕产妇死亡。该研究未报告围产期死亡率。与常规护理相比,自我监测可能导致子痫前期的诊断略多(风险比(RR)1.49,95%置信区间(CI)0.87至2.54;154名女性;1项研究;低确定性证据),但95%CI范围较宽,既可能有益也可能有害。与常规护理相比,自我监测对引产可能性的影响可能很小或没有影响(RR 1.09,95%CI 0.82至1.45;154名女性;1项研究;低确定性证据)。我们不确定自我监测血压与常规护理相比对孕产妇入住重症监护病房、死产、新生儿死亡或早产是否有任何影响(RR 1.54,95%CI 0.06至37.25;154名女性;1项研究;低确定性证据),因为证据的确定性较低,95%CI既可能有明显危害也可能有明显益处。与常规护理相比,自我监测可能导致新生儿住院略多(RR 1.53,95%CI 0.65至3.62;154名女性;1项研究;低确定性证据),但95%CI范围较宽,包括自我监测导致住院略少的可能性。血压测量技术:用柯氏音第IV期(K4,声音减弱)与柯氏音第V期(K5,声音消失)代表舒张压(1项研究,220名女性)K4组和K5组均无孕产妇死亡。使用K4或K5代表舒张压诊断子痫前期可能几乎没有差异(RR 1.16;95%CI 0.89至1.49;1项研究;220名女性;低确定性证据),因为95%CI范围较宽,包括K4诊断更多的可能性。我们不确定两组围产期死亡率是否有差异,因为证据质量较低,95%CI既可能有明显危害也可能有明显益处(RR 1.14,95%CI 0.16至7.92;1项研究,220名女性;低确定性证据)。该试验未报告孕产妇入住重症监护病房、引产、死产、新生儿死亡、早产或新生儿住院的数据。血压测量技术:CRADLE干预措施(CRADLE设备,一种具有附加功能的半自动血压监测仪和一套教育资料)与常规护理(1项研究,536,233例分娩)使用CRADLE设备与常规护理相比,孕产妇死亡数量可能几乎没有差异(调整RR 0.80,95%CI 0.30至2.11;536,233名女性;1项研究;低确定性证据),但95%CI既可能有明显危害也可能有明显益处。该试验未报告子痫前期、引产、围产期死亡率、早产或新生儿住院情况。仅对一小部分女性收集了孕产妇入住重症监护病房和围产期结局(死产和新生儿死亡)的数据,这些数据是根据结局而非基线特征确定的,从而打破了随机分配。因此,两组之间的任何差异都不能归因于干预措施,我们未提取这些结局的数据。
自我监测血压在高血压妊娠中的益处(如果有的话)仍然不确定,因为证据仅限于一项可行性研究。对于妊娠高血压女性,目前使用K5测量舒张压的做法是有依据的。由于试验研究设计的局限性和不稳定性,使用CRADLE设备测量血压在妊娠中的益处(如果有的话)仍然不确定。