Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension

NCT03449277 | Unknown Phase 4 DMC

• 1 other identifier: U1111-1209-5934
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.chronic hypertension that precedes pregnancy
2. 2.pre eclampsia and eclampsia: a systematic syndrome of elevated arterial pressure,proteinuria and other findings
3. 3.pre eclampsia superimposed upon chronic hypertension
4. 4.gestational hypertension or nonproteinuric hypertension of pregnancy

Conditions

Postpartum Preeclampsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Resolution of complications

  till discharge of hospital about two days

• Improvement of hematological values

  till discharge of hospital about two days

• Side effects in both groups

  till discharge of hospital about two days

• Improvement of other investigations

  till discharge of hospital about two days

Study Arms (2)

take oral nifedipine tablets

ACTIVE COMPARATOR

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

Drug: Oral Tablet

take oral labetalol tablets

ACTIVE COMPARATOR

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

Drug: Oral Tablet

Interventions

Oral Tablet DRUG

oral labetalol tablets and oral nifedipine tablets

Also known as: Monitoring blood pressure

take oral labetalol tablets; take oral nifedipine tablets

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women who have hypertension during pregnancy and persist after delivery till discharge of hospital about 2 days of monitoring the blood pressure

You may not qualify if:

• 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

Sponsors & Collaborators

• Hossam Ahmed Abd Ellah: lead
• Assiut University: collaborator

Study Sites (1)

Hossam Ahmed Abd Ellah

Asyut, Egypt

RECRUITING

Related Publications (6)

• 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/

  PMID: 23741776 BACKGROUND

• 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.

  PMID: 17253478 BACKGROUND

• 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.

  PMID: 23633317 BACKGROUND

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

  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.

  PMID: 8735301 BACKGROUND

• 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.

  PMID: 11416689 BACKGROUND

MeSH Terms

Interventions

Tablets; Blood Pressure Monitors

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Sphygmomanometers; Diagnostic Equipment; Equipment and Supplies

Study Officials

• Mohamed Mahmoud, Prof

  Prof of ob& Gyn

  STUDY DIRECTOR

Central Study Contacts

Hossam Ahmed Abd Ellah, MBBCH

CONTACT

0201119939775; drhaaada@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 28, 2018
• Study Start: January 19, 2018
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: April 4, 2018

Record last verified: 2018-04

Locations

EG (1)