Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension

Study Overview
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Brief Summary
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Hypertensive disorders of pregnancy are important cause of severe morbidity, long-term disability and death among both mothers and their babies. In Africa and Asia, nearly one tenth of all maternal deaths are associated with hypertensive disorders of pregnancy research has focused on the antenatal complications' for both mother and baby and the risks and benefits of administering antihypertensive therapy prior to delivery hypertension disorders of pregnancy often persist following delivery and sometimes arise de novo postpartum one of the maternal complications of pre eclampsia is residual chronic hypertension in about 1/3 of cases elevated blood pressure is seen in 6%to 8% of all pregnancies hypertension (arterial pressure >140/90 mmhg) in pregnancy is classified into one of four conditions chronic hypertension that precedes pregnancy pre eclampsia and eclampsia: a systematic syndrome of elevated arterial pressure,proteinuria and other findings pre eclampsia superimposed upon chronic hypertension gestational hypertension or nonproteinuric hypertension of pregnancy

Detailed Description
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Hypertensive disorders of pregnancy are important cause of severe morbidity, long-term disability and death among both mothers and their babies. In Africa and Asia, nearly one tenth of all maternal deaths are associated with hypertensive disorders of pregnancy research has focused on the antenatal complications' for both mother and baby and the risks and benefits of administering antihypertensive therapy prior to delivery hypertension disorders of pregnancy often persist following delivery and sometimes arise de novo postpartum one of the maternal complications of pre eclampsia is residual chronic hypertension in about 1/3 of cases elevated blood pressure is seen in 6%to 8% of all pregnancies hypertension (arterial pressure >140/90 mmhg) in pregnancy is classified into one of four conditions chronic hypertension that precedes pregnancy pre eclampsia and eclampsia: a systematic syndrome of elevated arterial pressure,proteinuria and other findings pre eclampsia superimposed upon chronic hypertension gestational hypertension or nonproteinuric hypertension of pregnancy evaluate the effectiveness, safety and acceptability of Oral nifedipine versus oral labetalol in treatment of persistent postpartum hypertension

Official Title
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Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension

Conditions
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Postpartum Preeclampsia

Intervention / Treatment
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* Drug: Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who have hypertension during pregnancy and persist after delivery till discharge of hospital about 2 days of monitoring the blood pressure Exclusion Criteria: Women with history of secondary hypertension Women with eclampsia who need intensive care unit admission and indicated other drugs rather than oral nifedipine and oral labetalol Women who have any contraindication to Nifedipine or labetalol

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: take oral nifedipine tablets<br>Women who take the oral tablets of nifedipine till discharge of hospital | Drug: Oral Tablet<br>* oral labetalol tablets and oral nifedipine tablets<br>* Other names: Monitoring blood pressure;|
| Active Comparator: take oral labetalol tablets<br>Women who take the oral tablets of labetalol till discharge of hospital | Drug: Oral Tablet<br>* oral labetalol tablets and oral nifedipine tablets<br>* Other names: Monitoring blood pressure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| control blood pressure | duration,total dose to achieve blood pressure below the critical value between 140 and 150 mmHg systolic and 90-100 mmHg diastolic by monitoring of blood pressure | till discharge of hospital about two days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of complications | Measured by monitoring of blood pressure and monitoring of the complications | till discharge of hospital about two days | 
| Improvement of hematological values | By repeated Complete blood count | till discharge of hospital about two days | 
| Side effects in both groups | Monitoring if there is any side effect of any drug | till discharge of hospital about two days | 
| Improvement of other investigations | Monitoring by repeated urine analysis,other investigations | till discharge of hospital about two days |