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Status unknownNCT03449277Updated Apr 4, 2018

Oral Nifedipine Versus Labetalol in Treatment of Postpartum Hypertension

A Phase 4 interventional study of Oral Tablet in Postpartum Preeclampsia, sponsored by Hossam Ahmed Abd Ellah. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-04-04.

Sponsored by Hossam Ahmed Abd Ellah · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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
Read the 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
02

Conditions studied

  • Postpartum Preeclampsia
03

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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

04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    take oral nifedipine tablets

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

    Drug: Oral Tablet

  • Active comparator
    take oral labetalol tablets

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

    Drug: Oral Tablet

Interventions

  • DrugOral Tablet

    oral labetalol tablets and oral nifedipine tablets

    Also known as: Monitoring blood pressure

05

What researchers measure

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

    Time frame: till discharge of hospital about two days

Secondary outcomes

  1. Resolution of complications

    Measured by monitoring of blood pressure and monitoring of the complications

    Time frame: till discharge of hospital about two days

  2. Improvement of hematological values

    By repeated Complete blood count

    Time frame: till discharge of hospital about two days

  3. Side effects in both groups

    Monitoring if there is any side effect of any drug

    Time frame: till discharge of hospital about two days

  4. Improvement of other investigations

    Monitoring by repeated urine analysis,other investigations

    Time frame: till discharge of hospital about two days

06

Study locations

1 of 1 sites recruiting
  • Hossam Ahmed Abd Ellah
    Assiut, Egypt
    Recruiting
07

References and documents

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/ PubMed 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. PubMed 17253478 ↗
  • Magee L, von Dadelszen P. Prevention and treatment of postpartum hypertension. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004351. doi: 10.1002/14651858.CD004351.pub3. PubMed 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. PubMed 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. PubMed 11416689 ↗
08

Registry details

Key details

Study ID
NCT03449277
Lead sponsor
Hossam Ahmed Abd Ellah
Collaborators
Assiut University
Responsible party
Hossam Ahmed Abd Ellah (Principal investigator, Assiut University) — Sponsor-investigator
First posted
Feb 28, 2018
Start date
Jan 19, 2018
Primary completion
Feb 1, 2019 (estimated)
Completion
Mar 1, 2019 (estimated)
Last update
Apr 4, 2018

Study contacts

Hossam Ahmed Abd Ellah, MBBCH
Contact
drhaaada@gmail.com
0201119939775
Mohamed Mahmoud, Prof
study director · Prof of ob& Gyn

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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