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Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension

NCT03449277 — Phase 4, Unknown, 100 participants, Hossam Ahmed Abd Ellah

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RegistryNCT03449277
StatusUnknown
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment100 (Estimated)
SponsorHossam Ahmed Abd Ellah (Other); collaborators: Assiut University
ConditionsPostpartum Preeclampsia
InterventionsOral Tablet (Drug)
Datesstart 2018-01-19, primary completion 2019-02-01 (estimated), completion 2019-03-01 (estimated), first posted 2018-02-28, last updated 2018-04-04
Locations1 site in Egypt

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-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

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+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

+Arms and interventions

ArmTypeInterventionsDescription
take oral nifedipine tabletsActive comparatorDrug: Oral TabletWomen who take the oral tablets of nifedipine till discharge of hospital
take oral labetalol tabletsActive comparatorDrug: Oral TabletWomen who take the oral tablets of labetalol till discharge of hospital
  • Oral Tablet (Drug), also known as Monitoring blood pressure: oral labetalol tablets and oral nifedipine tablets

+Outcome measures

Primary outcomes

  • control blood pressure [till discharge of hospital about two days]: 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 outcomes

  • Resolution of complications [till discharge of hospital about two days]: Measured by monitoring of blood pressure and monitoring of the complications
  • Improvement of hematological values [till discharge of hospital about two days]: By repeated Complete blood count
  • Side effects in both groups [till discharge of hospital about two days]: Monitoring if there is any side effect of any drug
  • Improvement of other investigations [till discharge of hospital about two days]: Monitoring by repeated urine analysis,other investigations

+Eligibility

Sex: Female, ages: 20 Years to 40 Years

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

+Locations (1)

FacilityCityCountryStatus
Hossam Ahmed Abd EllahAsyutEgyptRecruiting

+Publications

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

+Investigators

My Notes