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Oral labetalol versus oral nifedipine for the management of postpartum hypertension a randomized control trial.

ABSTRACT: Objective:To compare the efficacy of oral Labetalol versus oral Nifedipine for the treatment of postpartum hypertension. Methods:A prospective randomized controlled trial with parallel assignment was conducted in the department of Obstetrics and Gynecology, Dow University of Health Sciences Karachi, Pakistan, 124 patients with post partum hypertension were selected and randomized into two groups with 62 patients receiving Labetalol and 62 receiving long acting nifedipine. Initial blood pressures were recorded, and the respective drug was administered. Dose adjustments were performed in the initial 24 hours. The outcome was measured in the form of drug efficacy by lowering of systolic blood pressure less than 140mm of Hg and diastolic less than 90mm of Hg up to 48 hours after starting treatment. Data was entered and analyzed through SPSS version 20. Results:Our study randomized 62 women to oral labetalol and 62 women to oral long acting nifedipine. The time required to achieve blood pressure control was 35.6±2.8 hours in labetalol group and 30.4±1.9 hours in nifedipine group (p=0.04).length of hospital stay, need of additional antihypertensive medications were same in both groups. Minor side effects were observed more in nifedipine group. Conclusion:We conclude that both oral labetalol and oral long acting nifedipine are effective and well tolerated interventions for the management of post-partum hypertension. However we found Nifidipine more effective in the management of postpartum hypertension.

SUBMITTER: Ainuddin J

PROVIDER: S-EPMC6717493 | biostudies-literature | 2019 Sep-Oct

REPOSITORIES: biostudies-literature

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Oral labetalol versus oral nifedipine for the management of postpartum hypertension a randomized control trial.

Ainuddin Jahanara J Javed Fariha F Kazi Sarah S

Pakistan journal of medical sciences 20190901 5

<h4>Objective</h4>To compare the efficacy of oral Labetalol versus oral Nifedipine for the treatment of postpartum hypertension.<h4>Methods</h4>A prospective randomized controlled trial with parallel assignment was conducted in the department of Obstetrics and Gynecology, Dow University of Health Sciences Karachi, Pakistan, 124 patients with post partum hypertension were selected and randomized into two groups with 62 patients receiving Labetalol and 62 receiving long acting nifedipine. Initial ...[more]

PMID: 31489020

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Project description:BackgroundApproximately one in ten women have high blood pressure during pregnancy. Hypertension is associated with adverse maternal and perinatal outcomes, and as treatment improves maternal outcomes, antihypertensive treatment is recommended. Previous trials have been unable to provide a definitive answer on which antihypertensive treatment is associated with optimal maternal and neonatal outcomes and the need for robust evidence evaluating maternal and infant benefits and risks remains an important, unanswered question for research and clinical communities.MethodsThe Giant PANDA study is a pragmatic, open-label, multicentre, randomised controlled trial of a treatment initiation strategy with nifedipine (calcium channel blocker), versus labetalol (mixed alpha/beta blocker) in 2300 women with pregnancy hypertension. The primary objective is to evaluate if treatment with nifedipine compared to labetalol in women with pregnancy hypertension reduces severe maternal hypertension without increasing fetal or neonatal death or neonatal unit admission. Subgroup analyses will be undertaken by hypertension type (chronic, gestational, pre-eclampsia), diabetes (yes, no), singleton (yes, no), self-reported ethnicity (Black, all other), and gestational age at randomisation categories (11 + 0 to 19 + 6, 20 + 0 to 27 + 6, 28 + 0 to 34 + 6 weeks). A cost-effectiveness analysis using an NHS perspective will be undertaken using a cost-consequence analysis up to postnatal hospital discharge and an extrapolation exercise with a lifetime horizon conditional on the results of the cost-consequence analysis.DiscussionThis trial aims to address the uncertainty of which antihypertensive treatment is associated with optimal maternal and neonatal outcomes. The trial results are intended to provide definitive evidence to inform guidelines and linked, shared decision-making tools, thus influencing clinical practice.Trial registrationEudraCT number: 2020-003410-12, ISRCTN: 12,792,616 registered on 18 November 2020.

Project description:BackgroundChanges during the puerperium are still unclear, particularly in women with hypertension. The choice of antihypertensives, both to control very high blood pressure episodes and to keep blood pressure stable, also requires further elucidation. Currently, there are no clear data to guide the decision for the choice of postpartum antihypertensives. Captopril plays an important role in the treatment of very high blood pressure episodes and may be used postpartum. Clonidine has been used as an alternative in pregnant or postpartum women with contraindications to captopril, with satisfactory effect. The objective of the present study was to evaluate the effectiveness and safety of clonidine compared to captopril for treating severe postpartum hypertension.Methods and findingsA randomized, drug-controlled, triple-blind clinical trial evaluating postpartum women receiving captopril or clonidine. Inclusion criteria consisted of: women with hypertensive disorders of pregnancy systolic blood pressure (SBP) ≥180 mmHg and/or diastolic blood pressure (DBP) ≥110 mmHg], requiring magnesium sulfate. Exclusion criteria were: heart disease, smoking, illicit drug use, contraindications to captopril, clonidine or oral medication, and having used captopril/clonidine previously. The primary outcome was the frequency of very high blood pressure episodes while in the obstetric intensive care unit. A total of 90 postpartum women met the study inclusion criteria, with 45 randomized to each group. There were fewer very high blood pressure episodes during hospitalization (2.1 ± 2.1 vs. 3.5 ± 4.7, p = 0.08), greater percentage reduction in SBP (14.0% ± 8.6% vs. 10.8% ± 8.8%, p = 0.08) and fewer women requiring sodium nitroprusside (2.3% vs. 13.3%; RR: 0.17; 95%CI: 0.02-1.39; p = 0.06) in the clonidine group compared to the captopril group; however, these differences were not significant. The groups were similar regarding daily mean SBP or DBP; however, on the third postpartum day, mean SBP was lower in the clonidine compared to the captopril group (151.9 ± 11.8 mmHg vs. 158.1 ± 13.6 mmHg, p = 0.02). Although not statistically significant, adverse reactions were more common in the captopril group (28.8%) compared to the clonidine group (18.6%).ConclusionClonidine and captopril represent safe, effective treatments for severe postpartum hypertension.Trial registrationclinicaltrials.gov: www.clinicaltrial.gov, NCT01761916.

Project description:Background Sildenafil is the drug of choice for neonatal pulmonary hypertension in developing countries where inhaled nitric oxide is not available. Available as oral and intravenous preparation – no study has been done in the past to compare the two forms. Each has its own benefits – but requires comparison in terms of efficacy and safety. This study was done to compare the efficacy of oral versus intravenous (IV) sildenafil in infants with mild to moderate pulmonary hypertension. Methods An open labelled randomized trial was conducted in a neonatal intensive care unit of urban tertiary hospital in western India between February 2019 to December 2020. Infants born after 34 weeks of gestation with Pulmonary arterial pressure (PAP) > 25 mm Hg measured by echocardiography, within 72 h of birth, were enrolled for the study. Participants were randomly assigned to receive sildenafil either orally or by intravenous route. Primary outcome was the time taken for PAP to decrease below 25 mm Hg. Secondary outcomes were time taken for oxygenation index to decrease by 25%, duration of invasive and non-invasive mechanical ventilation, nasal oxygen, hospital stay, time to achieve full feeds, mortality, and side effects. Results Forty patients were enrolled. The baseline characteristics of neonates in both groups were similar except for APGAR scores at 1 min and 5 min, with oral group having lower score [MEDIAN (IQR) 5.00 (4.00- 7.00) and 7.00 (6.00- 8.00)] compared to IV group [MEDIAN (IQR) 7.00 (6.00–8.00) and 9.00 (8.00–9.00)] respectively. Time taken for PAP to decrease below 25 mm was not statistically different between the oral and intravenous groups. Systemic hypotension occurred in 4 neonates of the intravenous group but none in the oral group. Conclusion Oral and intravenous sildenafil had equal efficacy at reducing PAP in neonatal pulmonary hypertension, albeit intravenous sildenafil use was associated with a greater complication rate. Trial registration Trial was registered in the clinical trials registry of India [CTRI/2019/04/018781][25/04/2019]. Supplementary Information The online version contains supplementary material available at 10.1186/s12887-022-03366-3.

Project description:BACKGROUND:Resource barriers complicate diabetes care management. Support from peers may help patients manage their diabetes. OBJECTIVE:To compare a reciprocal peer-support (RPS) program with nurse care management (NCM). DESIGN:Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00320112) SETTING:2 U.S. Department of Veterans Affairs health care facilities. PATIENTS:244 men with hemoglobin A(1c) (HbA(1c)) levels greater than 7.5% during the previous 6 months. MEASUREMENTS:The primary outcome was 6-month change in HbA(1c) level. Secondary outcomes were changes in insulin therapy; blood pressure; and patient reports of medication adherence, diabetes-related support, and emotional distress. INTERVENTION:Patients in the RPS group attended an initial group session to set diabetes-related behavioral goals, receive peer communication skills training, and be paired with another age-matched peer patient. Peers were encouraged to talk weekly using a telephone platform that recorded call occurrence and provided reminders to promote peer contact. These patients could also participate in optional group sessions at 1, 3, and 6 months. Patients in the NCM group attended a 1.5-hour educational session and were assigned to a nurse care manager. RESULTS:Of the 244 patients enrolled, 216 (89%) completed the HbA(1c) assessments and 231 (95%) completed the survey assessments at 6 months. Mean HbA(1c) level decreased from 8.02% to 7.73% (change, -0.29%) in the RPS group and increased from 7.93% to 8.22% (change, 0.29%) in the NCM group. The difference in HbA(1c) change between groups was 0.58% (P = 0.004). Among patients with a baseline HbA(1c) level greater than 8.0%, those in the RPS group had a mean decrease of 0.88%, compared with a 0.07% decrease among those in the NCM group (between-group difference, 0.81%; P < 0.001). Eight patients in the RPS group started insulin therapy, compared with 1 patient in the NCM group (P = 0.020). Groups did not differ in blood pressure, self-reported medication adherence, or diabetes-specific distress, but the RPS group reported improvement in diabetes social support. LIMITATION:The study included only male veterans and lasted only 6 months. CONCLUSION:Reciprocal peer support holds promise as a method for diabetes care management.

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Oral labetalol versus oral nifedipine for the management of postpartum hypertension a randomized control trial.

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Oral labetalol versus oral nifedipine for the management of postpartum hypertension a randomized control trial.

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