Clinical trial NCT03449277: Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension
Official title: Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postpartum Preeclampsia
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2018-02-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: control blood pressure
timeFrame: till discharge of hospital about two days
Secondary outcomes:
measure: Resolution of complications
timeFrame: till discharge of hospital about two days
measure: Improvement of hematological values
timeFrame: till discharge of hospital about two days
measure: Side effects in both groups
timeFrame: till discharge of hospital about two days
measure: Improvement of other investigations
timeFrame: till discharge of hospital about two days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Hossam Ahmed Abd Ellah
Study officials:
affiliation: Prof of ob& Gyn
name: Mohamed Mahmoud, Prof
role: STUDY_DIRECTOR
References:
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/
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.
citation: 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.
citation: Geneva Foundation for Medical Education and Research 2017: hypertensive disorders in pregnancy
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.
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.