RETRACTED ARTICLE: Methyldopa versus labetalol or no medication for treatment of mild and moderate chronic hypertension during pregnancy: a randomized clinical trial

Rezk, Mohamed; Emarh, Mohamed; Masood, Alaa; Dawood, Ragab; Elshamy, Elsayed; Gamal, Awni; Badr, Hassan

doi:10.1080/10641955.2020.1791902

Cited by 10 publications

(13 citation statements)

References 13 publications

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“…Most prior studies were small, yielding inconclusive results, and many observational studies compared treated women to healthy pregnant women, making confounding likely. Our finding of lower SGA risk with methyldopa compared to labetalol (aOR 0.77, 95% CI 0.63 to 0.92) is consistent with one recent RCT, which found the prevalence of SGA was much lower with methyldopa than labetalol (21% vs. 41%;OR 0.37, 95% CI 0.23–0.61) [ 10 ]. Similar results were found by Magee et al in a secondary analysis of RCT data [ 11 ].…”

Section: Discussionsupporting

confidence: 90%

“…The Cochrane meta-analysis grouped together all β-blockers, which may obscure important differences between individual medications, especially as labetalol has different receptor specificity than other commonly used β-blockers. A recent RCT reported that methyldopa was associated with significantly lower risk of small for gestational age (SGA) and NICU admission compared to labetalol, with odds ratios on the order of 0.40, and that the two medications were associated with similar risk of severe maternal hypertension or preeclampsia [ 10 ]. However, the sample size was small (~150 women per arm) and many of their risk estimates had wide confidence intervals.…”

Section: Introductionmentioning

confidence: 99%

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Maternal and neonatal outcomes of antihypertensive treatment in pregnancy: A retrospective cohort study

et al. 2022

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Objective To compare maternal and infant outcomes with different antihypertensive medications in pregnancy. Design Retrospective cohort study. Setting Kaiser Permanente, a large healthcare system in the United States. Population Women aged 15–49 years with a singleton birth from 2005–2014 treated for hypertension. Methods We identified medication exposure from automated pharmacy data based on the earliest dispensing after the first prenatal visit. Using logistic regression, we calculated weighted outcome prevalences, adjusted odds ratios (aORs) and 95% confidence intervals, with inverse probability of treatment weighting to address confounding. Main outcome measures Small for gestational age, preterm delivery, neonatal and maternal intensive care unit (ICU) admission, preeclampsia, and stillbirth or termination at > 20 weeks. Results Among 6346 deliveries, 87% with chronic hypertension, the risk of the infant being small for gestational age (birthweight < 10th percentile) was lower with methyldopa than labetalol (prevalence 13.6% vs. 16.6%; aOR 0.77, 95% CI 0.63 to 0.92). For birthweight < 3rd percentile the aOR was 0.57 (0.39 to 0.80). Compared with labetalol (26.0%), risk of preterm delivery was similar for methyldopa (26.5%; aOR 1.10 [0.95 to 1.27]) and slightly higher for nifedipine (28.5%; aOR 1.25 [1.06 to 1.46]) and other β-blockers (31.2%; aOR 1.58 [1.07 to 2.23]). Neonatal ICU admission was more common with nifedipine than labetalol (25.9% vs. 23.3%, aOR 1.21 [1.02 to 1.43]) but not elevated with methyldopa. Risks of other outcomes did not differ by medication. Conclusions Risk of most outcomes was similar comparing labetalol, methyldopa and nifedipine. Risk of the infant being small for gestational age was substantially lower for methyldopa, suggesting this medication may warrant further consideration.

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Section: Discussionsupporting

confidence: 90%

Section: Introductionmentioning

confidence: 99%

Maternal and neonatal outcomes of antihypertensive treatment in pregnancy: A retrospective cohort study

et al. 2022

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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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“…9 Labetalol was found to decrease maternal morbidity to a significant extent but a study showed higher rates of small for gestational age infants, neonatal hyperbilirubenemia and neonatal hypotension and thus more NICU admissions in neonates of women treated with labetalol. 10 Labetalol when compared to methyldopa or no treatment was found to lower fetal and maternal morbidity in another study. Women showed increase in platelet count and reduced proteinurea after treatment initiation.…”

Section: Introductionmentioning

confidence: 90%

Oral Labetalol in Comparison with Methyldopa in Treatment of Gestational Hypertension as a First Line Drug

Akhter¹,

Hashmi²,

Kaynat³

et al. 2023

PJMHS

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Background: Defining hypertension in pregnancy, it is taken as systolic blood pressure of 140 or more and diastolic blood pressure of 90mg or more. Presence of proteinurea differentiates chronic hypertension and gestational hypertension from pre eclampsia .Prevalence and incidence of hypertension in pregnancy along with its complications like end-organ damage, preeclampsia, eclampsia, and postpartum eclampsia are increasing. Gestational hypertension and its sequels are major causes of fetal and maternal morbidity and mortality and affect almost 8% of pregnancies. Labetalol and methyldopa were effective in reducing systolic and diastolic BP significantly but labetalol was found to control BP more rapidly and efficiently. Safety profile of both drugs was similar. The rationale of this study is Labetalol is more effective in comparison with Methyldopa in pregnancy induced hypertensive females in terms of control of blood pressure within 48hours of drug intake, in pregnant patients between POG of 28 to 32 weeks. Design: Randomized control trial. Place and Duration of Study: Department of Gynaecology Unit 2 Bahawal Victoria Hospital, Bahawalpur from 1st January 2022 to 31st December 2022. Methodology: One hundred 100 patients having gestational hypertension between periods of gestation from 28to 32 weeks were enrolled. They were divided into 2 groups; group A treated with labetalol and B treated with methyldopa respectively. Results: Statistical no significant difference in systolic and diastolic blood pressure was observed before starting treatment in both groups but a significant fall in diastolic blood pressure was observed in group A after 48 hrs of initiation of treatment i.e., with labetalol (P = 0.007) Conclusion: Both labetalol and methyldopa reduce blood pressure in women with gestational hypertension but labetalol is more effective than methyldopa as proved by our study. Keywords: Gestational hypertension, Diastolic blood pressure, Labetalol, Methyldopa

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RETRACTED ARTICLE: Methyldopa versus labetalol or no medication for treatment of mild and moderate chronic hypertension during pregnancy: a randomized clinical trial

Cited by 10 publications

References 13 publications

Maternal and neonatal outcomes of antihypertensive treatment in pregnancy: A retrospective cohort study

Maternal and neonatal outcomes of antihypertensive treatment in pregnancy: A retrospective cohort study

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

Oral Labetalol in Comparison with Methyldopa in Treatment of Gestational Hypertension as a First Line Drug

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