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Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension

Primary Purpose

Postpartum Preeclampsia

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Oral Tablet
Sponsored by
Hossam Ahmed Abd Ellah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Preeclampsia

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hossam Ahmed Abd EllahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

take oral nifedipine tablets

take oral labetalol tablets

Arm Description

Women who take the oral tablets of nifedipine till discharge of hospital

Women who take the oral tablets of labetalol till discharge of hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Resolution of complications
Measured by monitoring of blood pressure and monitoring of the complications
Improvement of hematological values
By repeated Complete blood count
Side effects in both groups
Monitoring if there is any side effect of any drug
Improvement of other investigations
Monitoring by repeated urine analysis,other investigations

Full Information

First Posted
February 19, 2018
Last Updated
April 2, 2018
Sponsor
Hossam Ahmed Abd Ellah
Collaborators
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03449277
Brief Title
Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension
Official Title
Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 19, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Anticipated)
Study Completion Date
March 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hossam Ahmed Abd Ellah
Collaborators
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Preeclampsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
take oral nifedipine tablets
Arm Type
Active Comparator
Arm Description
Women who take the oral tablets of nifedipine till discharge of hospital
Arm Title
take oral labetalol tablets
Arm Type
Active Comparator
Arm Description
Women who take the oral tablets of labetalol till discharge of hospital
Intervention Type
Drug
Intervention Name(s)
Oral Tablet
Other Intervention Name(s)
Monitoring blood pressure
Intervention Description
oral labetalol tablets and oral nifedipine tablets
Primary Outcome Measure Information:
Title
control blood pressure
Description
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
Time Frame
till discharge of hospital about two days
Secondary Outcome Measure Information:
Title
Resolution of complications
Description
Measured by monitoring of blood pressure and monitoring of the complications
Time Frame
till discharge of hospital about two days
Title
Improvement of hematological values
Description
By repeated Complete blood count
Time Frame
till discharge of hospital about two days
Title
Side effects in both groups
Description
Monitoring if there is any side effect of any drug
Time Frame
till discharge of hospital about two days
Title
Improvement of other investigations
Description
Monitoring by repeated urine analysis,other investigations
Time Frame
till discharge of hospital about two days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hossam Ahmed Abd Ellah, MBBCH
Phone
0201119939775
Email
drhaaada@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Mahmoud, Prof
Organizational Affiliation
Prof of ob& Gyn
Official's Role
Study Director
Facility Information:
Facility Name
Hossam Ahmed Abd Ellah
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hossam Ahmed Abd Ellah, MBBCH
Phone
0201119939775
Email
drhaaada@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
23741776
Citation
WHO Recommendations for Prevention and Treatment of Pre-Eclampsia and Eclampsia. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK140561/
Results Reference
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PubMed Identifier
17253478
Citation
Abalos E, Duley L, Steyn DW, Henderson-Smart DJ. Antihypertensive drug therapy for mild to moderate hypertension during pregnancy. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD002252. doi: 10.1002/14651858.CD002252.pub2.
Results Reference
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PubMed Identifier
23633317
Citation
Magee L, von Dadelszen P. Prevention and treatment of postpartum hypertension. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004351. doi: 10.1002/14651858.CD004351.pub3.
Results Reference
background
Citation
Geneva Foundation for Medical Education and Research 2017: hypertensive disorders in pregnancy
Results Reference
background
PubMed Identifier
8735301
Citation
ACOG technical bulletin. Hypertension in pregnancy. Number 219--January 1996 (replaces no. 91, February 1986). Committee on Technical Bulletins of the American College of Obstetricians and Gynecologists. Int J Gynaecol Obstet. 1996 May;53(2):175-83. No abstract available.
Results Reference
background
PubMed Identifier
11416689
Citation
Lenfant C; National Education Program Working Group on High Blood Pressure in Pregnancy. Working group report on high blood pressure in pregnancy. J Clin Hypertens (Greenwich). 2001 Mar-Apr;3(2):75-88. doi: 10.1111/j.1524-6175.2001.00458.x.
Results Reference
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Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension

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