Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension

NCT ID: NCT03449277

Last Updated: 2018-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-19

Study Completion Date

2019-03-01

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

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

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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

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

Conditions

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Postpartum Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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take oral nifedipine tablets

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

Group Type ACTIVE_COMPARATOR

Oral Tablet

Intervention Type DRUG

oral labetalol tablets and oral nifedipine tablets

take oral labetalol tablets

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

Group Type ACTIVE_COMPARATOR

Oral Tablet

Intervention Type DRUG

oral labetalol tablets and oral nifedipine tablets

Interventions

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Oral Tablet

oral labetalol tablets and oral nifedipine tablets

Intervention Type DRUG

Other Intervention Names

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Monitoring blood pressure

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role collaborator

Hossam Ahmed Abd Ellah

OTHER

Sponsor Role lead

Responsible Party

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Hossam Ahmed Abd Ellah

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohamed Mahmoud, Prof

Role: STUDY_DIRECTOR

Prof of ob& Gyn

Locations

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Hossam Ahmed Abd Ellah

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hossam Ahmed Abd Ellah, MBBCH

Role: CONTACT

0201119939775

Facility Contacts

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Hossam Ahmed Abd Ellah, MBBCH

Role: primary

0201119939775

References

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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/

Reference Type BACKGROUND
PMID: 23741776 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17253478 (View on PubMed)

Magee L, von Dadelszen P. Prevention and treatment of postpartum hypertension. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD004351. doi: 10.1002/14651858.CD004351.pub3.

Reference Type BACKGROUND
PMID: 23633317 (View on PubMed)

Geneva Foundation for Medical Education and Research 2017: hypertensive disorders in pregnancy

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 8735301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11416689 (View on PubMed)

Other Identifiers

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U1111-1209-5934

Identifier Type: -

Identifier Source: org_study_id

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