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Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension

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ClinicalTrials.gov Identifier: NCT03449277
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
Assiut University
Information provided by (Responsible Party):
Hossam Ahmed Abd Ellah, Assiut University

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

Condition or disease Intervention/treatment Phase
Postpartum Preeclampsia Drug: Oral Tablet Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension
Actual Study Start Date : January 19, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : March 1, 2019


Arm Intervention/treatment
Active Comparator: take oral nifedipine tablets
Women who take the oral tablets of nifedipine till discharge of hospital
Drug: Oral Tablet
oral labetalol tablets and oral nifedipine tablets
Other Name: Monitoring blood pressure

Active Comparator: take oral labetalol tablets
Women who take the oral tablets of labetalol till discharge of hospital
Drug: Oral Tablet
oral labetalol tablets and oral nifedipine tablets
Other Name: Monitoring blood pressure




Primary Outcome Measures :
  1. control blood pressure [ Time Frame: 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 :
  1. Resolution of complications [ Time Frame: till discharge of hospital about two days ]
    Measured by monitoring of blood pressure and monitoring of the complications

  2. Improvement of hematological values [ Time Frame: till discharge of hospital about two days ]
    By repeated Complete blood count

  3. Side effects in both groups [ Time Frame: till discharge of hospital about two days ]
    Monitoring if there is any side effect of any drug

  4. Improvement of other investigations [ Time Frame: till discharge of hospital about two days ]
    Monitoring by repeated urine analysis,other investigations



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449277


Contacts
Contact: Hossam Ahmed Abd Ellah, MBBCH 0201119939775 drhaaada@gmail.com

Locations
Egypt
Hossam Ahmed Abd Ellah Recruiting
Assiut, Egypt
Contact: Hossam Ahmed Abd Ellah, MBBCH    0201119939775    drhaaada@gmail.com   
Sponsors and Collaborators
Hossam Ahmed Abd Ellah
Assiut University
Investigators
Study Director: Mohamed Mahmoud, Prof Prof of ob& Gyn

Publications:
Responsible Party: Hossam Ahmed Abd Ellah, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03449277     History of Changes
Other Study ID Numbers: U1111-1209-5934
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Hypertension, Pregnancy-Induced
Pregnancy Complications
Pre-Eclampsia
Vascular Diseases
Cardiovascular Diseases
Nifedipine
Labetalol
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Antihypertensive Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists