Setting and techniques for monitoring blood pressure during pregnancy

Danielle C Ashworth, Sophie P Maule, Fiona Stewart, Hannah L Nathan, Andrew H Shennan, Lucy C Chappell, Danielle C Ashworth, Sophie P Maule, Fiona Stewart, Hannah L Nathan, Andrew H Shennan, Lucy C Chappell

Abstract

Background: 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.

Objectives: 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.

Search methods: 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.

Selection criteria: Randomised controlled trials (RCTs) involving pregnant women, using validated BP devices in different settings or using different techniques.

Data collection and analysis: Two authors independently extracted data, assessed risk of bias, and used the GRADE approach to assess the certainty of the evidence.

Main results: 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.

Trial registration: ClinicalTrials.gov NCT00809666 NCT03222414 NCT03334149 NCT03509272 NCT03648645 NCT03858595 NCT03978429 NCT04031430.

Conflict of interest statement

This project was supported by the National Institute for Health Research, via Cochrane Reviews of NICE Priority funding to Cochrane Pregnancy and Childbirth (award number 131142).

Danielle C Ashworth ‐ none known

Sophie P Maule ‐ none known

Fiona Stewart ‐ none known

Hannah Nathan ‐ Dr Nathan was involved in the development of the CRADLE VSA device with Professor Shennan and is co‐author of the CRADLE‐3 study paper (Vousden 2019).

Andrew Shennan – Professor Shennan is the inventor of the CRADLE VSA device and co‐author of the CRADLE‐3 study paper (Vousden 2019).

Lucy C Chappell ‐ Professor Chappell is a co‐author of the OPTIMUM‐BP study paper (Pealing 2019a), and the CRADLE‐3 study paper (Vousden 2019).

Hannah Nathan, Andrew Shennan, and Lucy C Chappell had no part in the assessment, data extraction, or data entry for either the OPTIMUM‐BP study paper (Pealing 2019a), or the CRADLE‐3 study paper (Vousden 2019).