Dataset Information

Treatment for Mild Chronic Hypertension during Pregnancy.

ABSTRACT:

Background

The benefits and safety of the treatment of mild chronic hypertension (blood pressure, <160/100 mm Hg) during pregnancy are uncertain. Data are needed on whether a strategy of targeting a blood pressure of less than 140/90 mm Hg reduces the incidence of adverse pregnancy outcomes without compromising fetal growth.

Methods

In this open-label, multicenter, randomized trial, we assigned pregnant women with mild chronic hypertension and singleton fetuses at a gestational age of less than 23 weeks to receive antihypertensive medications recommended for use in pregnancy (active-treatment group) or to receive no such treatment unless severe hypertension (systolic pressure, ≥160 mm Hg; or diastolic pressure, ≥105 mm Hg) developed (control group). The primary outcome was a composite of preeclampsia with severe features, medically indicated preterm birth at less than 35 weeks' gestation, placental abruption, or fetal or neonatal death. The safety outcome was small-for-gestational-age birth weight below the 10th percentile for gestational age. Secondary outcomes included composites of serious neonatal or maternal complications, preeclampsia, and preterm birth.

Results

A total of 2408 women were enrolled in the trial. The incidence of a primary-outcome event was lower in the active-treatment group than in the control group (30.2% vs. 37.0%), for an adjusted risk ratio of 0.82 (95% confidence interval [CI], 0.74 to 0.92; P<0.001). The percentage of small-for-gestational-age birth weights below the 10th percentile was 11.2% in the active-treatment group and 10.4% in the control group (adjusted risk ratio, 1.04; 95% CI, 0.82 to 1.31; P = 0.76). The incidence of serious maternal complications was 2.1% and 2.8%, respectively (risk ratio, 0.75; 95% CI, 0.45 to 1.26), and the incidence of severe neonatal complications was 2.0% and 2.6% (risk ratio, 0.77; 95% CI, 0.45 to 1.30). The incidence of any preeclampsia in the two groups was 24.4% and 31.1%, respectively (risk ratio, 0.79; 95% CI, 0.69 to 0.89), and the incidence of preterm birth was 27.5% and 31.4% (risk ratio, 0.87; 95% CI, 0.77 to 0.99).

Conclusions

In pregnant women with mild chronic hypertension, a strategy of targeting a blood pressure of less than 140/90 mm Hg was associated with better pregnancy outcomes than a strategy of reserving treatment only for severe hypertension, with no increase in the risk of small-for-gestational-age birth weight. (Funded by the National Heart, Lung, and Blood Institute; CHAP ClinicalTrials.gov number, NCT02299414.).

SUBMITTER: Tita AT

PROVIDER: S-EPMC9575330 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Publications

Treatment for Mild Chronic Hypertension during Pregnancy.

Tita Alan T AT Szychowski Jeff M JM Boggess Kim K Dugoff Lorraine L Sibai Baha B Lawrence Kirsten K Hughes Brenna L BL Bell Joseph J Aagaard Kjersti K Edwards Rodney K RK Gibson Kelly K Haas David M DM Plante Lauren L Metz Torri T Casey Brian B Esplin Sean S Longo Sherri S Hoffman Matthew M Saade George R GR Hoppe Kara K KK Foroutan Janelle J Tuuli Methodius M Owens Michelle Y MY Simhan Hyagriv N HN Frey Heather H Rosen Todd T Palatnik Anna A Baker Susan S August Phyllis P Reddy Uma M UM Kinzler Wendy W Su Emily E Krishna Iris I Nguyen Nicki N Norton Mary E ME Skupski Daniel D El-Sayed Yasser Y YY Ogunyemi Dotum D Galis Zorina S ZS Harper Lorie L Ambalavanan Namasivayam N Geller Nancy L NL Oparil Suzanne S Cutter Gary R GR Andrews William W WW

The New England journal of medicine 20220402 19

<h4>Background</h4>The benefits and safety of the treatment of mild chronic hypertension (blood pressure, <160/100 mm Hg) during pregnancy are uncertain. Data are needed on whether a strategy of targeting a blood pressure of less than 140/90 mm Hg reduces the incidence of adverse pregnancy outcomes without compromising fetal growth.<h4>Methods</h4>In this open-label, multicenter, randomized trial, we assigned pregnant women with mild chronic hypertension and singleton fetuses at a gestational ag ...[more]

PMID: 35363951

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Project description:Chronic hypertension complicates 1% to 2% of pregnancies, and it is increasingly common. Women with chronic hypertension are an easily recognized group who are in touch with a wide variety of healthcare providers before, during, and after pregnancy, mandating that chronic hypertension in pregnancy be within the scope of many practitioners. We reviewed recent data on management to inform current care and future research. This study is a narrative review of published literature. Compared with normotensive women, women with chronic hypertension are at an increased risk of maternal and perinatal complications. Women with chronic hypertension who wish to be involved in their care can do by measuring blood pressure at home. Accurate devices for home blood pressure monitoring are now readily available. The diagnostic criteria for superimposed preeclampsia remain problematic because most guidelines continue to include deteriorating blood pressure control in the definition. It has not been established how angiogenic markers may aid in confirmation of the diagnosis of superimposed preeclampsia when suspected, over and above information provided by routinely available clinical data and laboratory results. Although chronic hypertension is a strong risk factor for preeclampsia, and aspirin decreases preeclampsia risk, the effectiveness specifically among women with chronic hypertension has been questioned. It is unclear whether calcium has an independent effect in preeclampsia prevention in such women. Treating hypertension with antihypertensive therapy halves the risk of progression to severe hypertension, thrombocytopenia, and elevated liver enzymes, but a reduction in preeclampsia or serious maternal complications has not been observed; however, the lack of evidence for the latter is possibly owing to few events. In addition, treating chronic hypertension neither reduces nor increases fetal or newborn death or morbidity, regardless of the gestational age at which the antihypertensive treatment is started. Antihypertensive agents are not teratogenic, but there may be an increase in malformations associated with chronic hypertension itself. At present, blood pressure treatment targets used in clinics are the same as those used at home, although blood pressure values tend to be inconsistently lower at home among women with hypertension. Although starting all women on the same antihypertensive medication is usually effective in reducing blood pressure, it remains unclear whether there is an optimal agent for such an approach or how best to use combinations of antihypertensive medications. An alternative approach is to individualize care, using maternal characteristics and blood pressure features beyond blood pressure level (eg, variability) that are of prognostic value. Outcomes may be improved by timed birth between 38 0/7 and 39 6/7 weeks' gestation based on observational literature; of note, confirmatory trial evidence is pending. Postnatal care is facilitated by the acceptability of most antihypertensives (including angiotensin-converting enzymes inhibitors) for use in breastfeeding. The evidence base to guide the care of pregnant women with chronic hypertension is growing and aligning with international guidelines. Addressing outstanding research questions would inform personalized care of chronic hypertension in pregnancy.

Project description:BackgroundIn contrast to severe gestational hypertension, it is questioned whether antihypertensive medication for mild to moderate gestational hypertension prevents adverse maternal and offspring outcomes. Hypertensive drugs halve the risk of severe hypertension, but do not seem to prevent progression to preeclampsia or reduce the risk of complications in offspring. In fact, beta-blockers, a first line therapy option, are suspected to impair foetal growth. Disappointing effects of antihypertensive medication can be anticipated when the pharmacological mode of action does not match the underlying haemodynamic imbalance. Hypertension may result from 1) high cardiac output, low vascular resistance state, in which beta blockade is expected to be most effective, or 2) low cardiac output, high vascular resistance state where dihydropyridine calcium channel blockers or central-acting alpha agonists might be the best corrective medication. In the latter, beta-blockade might be maternally ineffective and even contribute to impaired foetal growth by keeping cardiac output low. We propose a randomized controlled trial to determine whether correcting the haemodynamic imbalance in women with mild to moderate hypertension reduces the development of severe hypertension and/or preeclampsia more than non-pharmacological treatment does, without alleged negative effects on foetal growth.MethodsWomen diagnosed with mild to moderate hypertension without proteinuria or signs of other organ damage before 37 weeks of pregnancy are invited to participate in this randomized controlled trial. Women randomized to the intervention group will be prescribed tailored antihypertensive medication, using a simple diagnostic and treatment algorithm based on the mean arterial pressure/heart rate ratio, which serves as an easy-to-determine proxy for maternal circulatory state. Women randomized to the control group will receive non-pharmacological standard care according to national and international guidelines. In total, 208 women will be randomized in a 1:1 ratio. The primary outcome is progression to severe hypertension and preeclampsia and the secondary outcomes are adverse maternal and neonatal outcomes.DiscussionThis trial will provide evidence of whether tailoring treatment of mild to moderate gestational hypertension to the individual haemodynamic profile prevents maternal disease progression.Trial registrationNCT02531490 , registered on 24 August 2015.

Project description:ObjectiveTo provide an accurate assessment of complications of pregnancy in women with chronic hypertension, including comparison with population pregnancy data (US) to inform pre-pregnancy and antenatal management strategies.DesignSystematic review and meta-analysis.Data sourcesEmbase, Medline, and Web of Science were searched without language restrictions, from first publication until June 2013; the bibliographies of relevant articles and reviews were hand searched for additional reports.Study selectionStudies involving pregnant women with chronic hypertension, including retrospective and prospective cohorts, population studies, and appropriate arms of randomised controlled trials, were included.Data extractionPooled incidence for each pregnancy outcome was reported and, for US studies, compared with US general population incidence from the National Vital Statistics Report (2006).Results55 eligible studies were identified, encompassing 795,221 pregnancies. Women with chronic hypertension had high pooled incidences of superimposed pre-eclampsia (25.9%, 95% confidence interval 21.0% to 31.5 %), caesarean section (41.4%, 35.5% to 47.7%), preterm delivery <37 weeks' gestation (28.1% (22.6 to 34.4%), birth weight <2500 g (16.9%, 13.1% to 21.5%), neonatal unit admission (20.5%, 15.7% to 26.4%), and perinatal death (4.0%, 2.9% to 5.4%). However, considerable heterogeneity existed in the reported incidence of all outcomes (τ(2)=0.286-0.766), with a substantial range of incidences in individual studies around these averages; additional meta-regression did not identify any influential demographic factors. The incidences (the meta-analysis average from US studies) of adverse outcomes in women with chronic hypertension were compared with women from the US national population dataset and showed higher risks in those with chronic hypertension: relative risks were 7.7 (95% confidence interval 5.7 to 10.1) for superimposed pre-eclampsia compared with pre-eclampsia, 1.3 (1.1 to 1.5) for caesarean section, 2.7 (1.9 to 3.6) for preterm delivery <37 weeks' gestation, 2.7 (1.9 to 3.8) for birth weight <2500 g, 3.2 (2.2 to 4.4) for neonatal unit admission, and 4.2 (2.7 to 6.5) for perinatal death.ConclusionsThis systematic review, reporting meta-analysed data from studies of pregnant women with chronic hypertension, shows that adverse outcomes of pregnancy are common and emphasises a need for heightened antenatal surveillance. A consistent strategy to study women with chronic hypertension is needed, as previous study designs have been diverse. These findings should inform counselling and contribute to optimisation of maternal health, drug treatment, and pre-pregnancy management in women affected by chronic hypertension.

Dataset Information

Treatment for Mild Chronic Hypertension during Pregnancy.

Background

Methods

Results

Conclusions

Publications

Treatment for Mild Chronic Hypertension during Pregnancy.

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