Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension

Postpartum Preeclampsia Clinical Trial

Official title:

Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03449277
• Other study ID #: U1111-1209-5934
• Status: Recruiting
• Phase: Phase 4
• First received: February 19, 2018
• Last updated: April 2, 2018
• Start date: January 19, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2018
• Source: Assiut University
• Contact: Hossam Ahmed Abd Ellah, MBBCH
• Phone: 0201119939775
• Email: drhaaada[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Postpartum Preeclampsia
• Pre-Eclampsia

Intervention

Drug:
• Oral Tablet
oral labetalol tablets and oral nifedipine tablets

Locations

Country	Name	City	State
Egypt	Hossam Ahmed Abd Ellah	Assiut

Sponsors (2)

Lead Sponsor	Collaborator
Hossam Ahmed Abd Ellah	Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. Review. Update in: Cochrane Database Syst Rev. 2014;2:CD002252. — View 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. — View Citation

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

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. — View Citation

Magee L,Sadeghi S,von Dadelszen P 2007 Cochrane: prevention and treatment of postpartum hypertension systemic review

world health organization recommendations for prevention and treatment of pre eclampia and eclampia 2011

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	till discharge of hospital about two days
Secondary	Resolution of complications	Measured by monitoring of blood pressure and monitoring of the complications	till discharge of hospital about two days
Secondary	Improvement of hematological values	By repeated Complete blood count	till discharge of hospital about two days
Secondary	Side effects in both groups	Monitoring if there is any side effect of any drug	till discharge of hospital about two days
Secondary	Improvement of other investigations	Monitoring by repeated urine analysis,other investigations	till discharge of hospital about two days