Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension

Phase 4

• Conditions: Postpartum Preeclampsia
• Interventions: Drug: Oral Tablet

• Registration Number: NCT03449277
• Lead Sponsor: Hossam Ahmed Abd Ellah

Brief Summary

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

1. chronic hypertension that precedes pregnancy

2. pre eclampsia and eclampsia: a systematic syndrome of elevated arterial pressure,proteinuria and other findings

3. pre eclampsia superimposed upon chronic hypertension

4. gestational hypertension or nonproteinuric hypertension of pregnancy

Detailed Description

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

1. chronic hypertension that precedes pregnancy

2. pre eclampsia and eclampsia: a systematic syndrome of elevated arterial pressure,proteinuria and other findings

3. pre eclampsia superimposed upon chronic hypertension

4. 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

Study Timeline

• Study Start: 2018-01-19
• Study First Submitted: 2018-02-19
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-02-28
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-02
• Last Update Posted: 2018-04-04
• Primary Completion: 2019-02-01
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
take oral labetalol tablets	Oral Tablet	Women who take the oral tablets of labetalol till discharge of hospital
take oral nifedipine tablets	Oral Tablet	Women who take the oral tablets of nifedipine till discharge of hospital

Primary Outcome Measures

Name	Time	Method
control blood pressure	till discharge of hospital about two days	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hossam Ahmed Abd Ellah; 🇪🇬 Assiut, Egypt