Methyldopa versus nifedipine or no medication for treatment of chronic hypertension during pregnancy: A multicenter randomized clinical trial

Salama, Mohamed; Rezk, Mohamed; Gaber, Wael; Hamza, H.A.; Marawan, Hala; Gamal, Awni; Abdallah, Sameh

doi:10.1016/j.preghy.2019.05.009

Cited by 23 publications

(18 citation statements)

References 16 publications

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“…Almost all the studies were at low risk of bias due to using a clear method for random sequence generation including randomization in blocks of six with serial numbers, 23 labeled allocations cards numbered 1–150, 13 a list generated by a computer, 17 a list of random numbers, 15 stratified blocks of 10 in 2 centers, 14 computer‐generated simple random tables, 18 random numbers generated by the computer, 21 web‐based randomization program with variable block sizes of 2, 4, and 6, 6 block sizes of 6 generated with the computer, 19 and simple random table 12 . Allocation concealment was at unclear or high risk of bias in half of the included studies 12,13,16,17,21,22 .…”

Section: Resultsmentioning

confidence: 99%

The impact of antihypertensive treatment of mild to moderate hypertension during pregnancy on maternal and neonatal outcomes: An updated meta‐analysis of randomized controlled trials

Attar

Hosseinpour

Moghadami

2023

Clinical Cardiology

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Currently, there is controversy regarding the treatment of pregnant patients with mild hypertension (blood pressure 140–159/90–109 mm Hg). While guidelines do not recommend this treatment, results from recent clinical trials are supportive of the treatment. This meta‐analysis aimed to clarify if active treatment of mild hypertension during pregnancy results in better maternal and fetal outcomes. All of the potentially eligible randomized controlled trials were retrieved through a systematic database search investigating the impact of pharmacological treatment in mild hypertensive patients on maternal, fetal, and neonatal outcomes. Relative risk (RR) and 95% confidence interval (CI) were calculated using a random‐effects model. Data from 12 trials comprising 4461 pregnant women diagnosed with mild to moderate hypertension (2395 in the intervention group and 2066 in the control group) were extracted for quantitative synthesis. Antihypertensive treatment was associated with better outcomes in seven out of the 19 analyzed outcomes: Severe hypertension (RR = 0.53; 95% CI = [0.38;0.75]), preeclampsia (RR = 0.71; 95% CI = [0.54; 0.93]), placental abruption (RR = 0.48; 95% CI = [0.26; 0.87]), changes in electrocardiogram (RR = 0.43; 95% CI = [0.25; 0.72]), renal impairment (RR = 0.42; 95% CI = [0.34; 0.51]), pulmonary edema (RR = 0.46; 95% CI = [0.25; 0.84]), and neonatal mortality (RR = 0.72; 95% CI = [0.57; 0.92]). The primary safety outcome of small for gestational age was not different between the treatment group and the control group (RR = 1.12; 95% CI = [0.80; 1.57]). The results of this meta‐analysis are in favor of the beneficial impact of pharmacological treatment of mild hypertension on both maternal and neonatal outcomes and without significant adverse events for the fetus.

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Section: Resultsmentioning

confidence: 99%

The impact of antihypertensive treatment of mild to moderate hypertension during pregnancy on maternal and neonatal outcomes: An updated meta‐analysis of randomized controlled trials

Attar

Hosseinpour

Moghadami

2023

Clinical Cardiology

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“…Further exclusions were made following title/abstract review (N=689 plus N=4 ongoing trials) and full-text review (N=8, four of which were designated as awaiting classification because further information was requested from the authors or a specific editorial caution had been issued). 17–25 Seventy-two trials were included—N=61 trials from the prior Cochrane review 1 and N=11 new trials, N=8 previously excluded from the Cochrane review, because they compared antihypertensives within the same drug class or N=3 because they were trials of differential BP control. 26–96 See Appendix in the Supplemental Material for the Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram (Figure S1) and checklist (Tables S3 and S4).…”

Section: Resultsmentioning

confidence: 99%

Oral Antihypertensives for Nonsevere Pregnancy Hypertension: Systematic Review, Network Meta- and Trial Sequential Analyses

et al. 2022

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Background: We aimed to address which antihypertensives are superior to placebo/no therapy or another antihypertensive for controlling nonsevere pregnancy hypertension and provide future sample size estimates for definitive evidence. Methods: Randomized trials of antihypertensives for nonsevere pregnancy hypertension were identified from online electronic databases, to February 28, 2021 (registration URL: https://www.crd.york.ac.uk/PROSPERO/ ; unique identifier: CRD42020188725). Our outcomes were severe hypertension, proteinuria/preeclampsia, fetal/newborn death, small-for-gestational age infants, preterm birth, and admission to neonatal care. A Bayesian random-effects model generated estimates of direct and indirect treatment comparisons. Trial sequential analysis informed future trials needed. Results: Of 1246 publications identified, 72 trials were included; 61 (6923 women) were informative. All commonly prescribed antihypertensives (labetalol, other β-blockers, methyldopa, calcium channel blockers, and mixed/multi-drug therapy) versus placebo/no therapy reduced the risk of severe hypertension by 30% to 70%. Labetalol decreased proteinuria/preeclampsia (odds ratio, 0.73 [95% credible interval, 0.54–0.99]) and fetal/newborn death (odds ratio, 0.54 [0.30–0.98]) compared with placebo/no therapy, and proteinuria/preeclampsia compared with methyldopa (odds ratio, 0.66 [0.44–0.99]) and calcium channel blockers (odds ratio, 0.63 [0.41–0.96]). No other differences were identified, but credible intervals were wide. Trial sequential analysis indicated that 2500 to 10 000 women/arm (severe hypertension or safety outcomes) to >15 000/arm (fetal/newborn death) would be required to provide definitive evidence. Conclusions: In summary, all commonly prescribed antihypertensives in pregnancy reduce the risk of severe hypertension, but labetalol may also decrease proteinuria/preeclampsia and fetal/newborn death. Evidence is lacking for many other safety outcomes. Prohibitive sample sizes are required for definitive evidence. Real-world data are needed to individualize care.

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“…Finally, eight studies (4211 participants) were included in our meta-analysis. [22][23][24][25][26][27][28][29][30] Figure 1 illustrates the investigational steps to identify RCTs to be included.…”

Section: Prisma Flow Diagrammentioning

confidence: 99%

“…For the "allocation concealment", two studies 22,29 were judged as having unclear risk of bias because the methods of allocation concealment were not reported. Three studies [26][27][28] had unclear risk of bias on "blinding of outcome assessment" as assessors may be subjective to some outcomes (Figure 2).…”

Section: Interventionmentioning

confidence: 99%

Treatment for mild hypertension in pregnancy with different strategies: A systematic review and meta‐analysis

Chen

Wang

Carru

et al. 2023

Intl J Gynecology & Obste

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Objectives: To synthesize the evidence from randomized controlled trials (RCTs) of antihypertensive treatment for mild pregnancy hypertension. Methods:We searched various databases from inception to June 2022, using keywords including hypertension; pregnancy; therapy; treatment; pregnancy outcomes; maternal outcomes; and perinatal outcomes. Only RCTs of antihypertensive treatment for mild hypertension in pregnancy comparing placebo/no therapy were included. We used Review Manager version 5.3 for statistical analyses.Results: In all, eight studies were eligible, with a total of 4211 participants. Compared with control, the active treatment significantly prevented preeclampsia (OR 0.55; 95%CI, 0.39-0.78), placental abruption (OR 0.39; 95%CI, 0.17-0.91), severe hypertension (OR 0.35; 95%CI, 0.17-0.71), end-organ dysfunction (OR 0.34; 95%CI, 0.19-0.62) and preterm birth (OR 0.69; 95%CI, 0.59-0.82), with no increased risk of small for gestational age (SGA) (OR 1.25; 95%CI, 0.78-2.00), or admission to the NICU (OR 0.83; 95%CI, 0.54-1.28). Subgroup analyses demonstrated that the tight control group did not show an advantage over the less-tight control group in improving pregnancy outcomes. Conclusion:In pregnant women with mild pregnancy-induced hypertension or chronic hypertension, antihypertensive treatment still provided precise benefits of improving pregnancy outcomes without increased risk in fetal outcomes.

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Methyldopa versus nifedipine or no medication for treatment of chronic hypertension during pregnancy: A multicenter randomized clinical trial

Cited by 23 publications

References 16 publications

The impact of antihypertensive treatment of mild to moderate hypertension during pregnancy on maternal and neonatal outcomes: An updated meta‐analysis of randomized controlled trials

The impact of antihypertensive treatment of mild to moderate hypertension during pregnancy on maternal and neonatal outcomes: An updated meta‐analysis of randomized controlled trials

Oral Antihypertensives for Nonsevere Pregnancy Hypertension: Systematic Review, Network Meta- and Trial Sequential Analyses

Treatment for mild hypertension in pregnancy with different strategies: A systematic review and meta‐analysis

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