Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension

Sponsor
Hossam Ahmed Abd Ellah (Other)
Overall Status
Unknown status
CT.gov ID
NCT03449277
Collaborator
Assiut University (Other)
100
1
2
13.3
7.5

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
Anticipated 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 :
Jan 19, 2018
Anticipated Primary Completion Date :
Feb 1, 2019
Anticipated Study Completion Date :
Mar 1, 2019

Arms and Interventions

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 Names:
  • 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 Names:
  • Monitoring blood pressure
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Resolution of complications [till discharge of hospital about two days]

      Measured by monitoring of blood pressure and monitoring of the complications

    2. Improvement of hematological values [till discharge of hospital about two days]

      By repeated Complete blood count

    3. Side effects in both groups [till discharge of hospital about two days]

      Monitoring if there is any side effect of any drug

    4. Improvement of other investigations [till discharge of hospital about two days]

      Monitoring by repeated urine analysis,other investigations

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hossam Ahmed Abd Ellah Assiut Egypt

    Sponsors and Collaborators

    • Hossam Ahmed Abd Ellah
    • Assiut University

    Investigators

    • Study Director: Mohamed Mahmoud, Prof, Prof of ob& Gyn

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hossam Ahmed Abd Ellah, Principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03449277
    Other Study ID Numbers:
    • U1111-1209-5934
    First Posted:
    Feb 28, 2018
    Last Update Posted:
    Apr 4, 2018
    Last Verified:
    Apr 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 4, 2018