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ISRCTN
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ISRCTN78140744
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ClinicalTrials.gov identifier
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Public title
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Oral Nifedipine versus Intravenous Labetalol hydrochloride for acute blood pressure control in Hypertensive Emergencies of Pregnancy
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Scientific title
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Oral nifedipine versus intravenous labetalol hydrochloride for acute blood pressure control in hypertensive emergencies of pregnancy: a double blind randomised clinical trial
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Acronym
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ONILHEP
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Serial number at source
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738.15
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Study hypothesis
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Oral nifedipine has a more rapid effect on blood pressure in a hypertensive emergency of pregnancy compared to intravenous labetalol hydrochloride.
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Lay summary
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Not provided at time of registration
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Ethics approval
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University of Malaya Medical Centre Medical Ethics Committee approved on the 8th September 2009 (ref: 738.15)
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Study design
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Double blind randomised clinical trial
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Countries of recruitment
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Malaysia
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Disease/condition/study domain
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Severe hypertension of pregnancy
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Participants - inclusion criteria
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1. Sustained severe hypertension defined as systolic blood pressure of greater than or equal to 160 mmHg and/or diastolic blood pressure greater than or equal to 110 mmHg on at least two occasions in the last 4 hours, at least 30 minutes apart. The latest blood pressure reading must fulfil the criteria of severe hypertension.
2. Medical decision to rapidly control blood pressure
3. Greater than or equal to 24 weeks gestation
4. Viable singleton foetus with acceptable cardiotocography (CTG)
5. Maternal heart rate greater than or equal to 60 bpm and less than or equal to 120 bpm
6. Aged 19 - 40 years, all pregnant females
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Participants - exclusion criteria
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1. Maternal history of cardiac arrhythmia
2. Heart failure
3. Asthma
4. Allergy or contraindication to either nifedipine or labetalol hydrochloride
5. Antihypertensive drug treatment in the last 72 hours
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Anticipated start date
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02/01/2010
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Anticipated end date
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18/10/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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50 in total
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Interventions
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Randomisation to regimen (A) nifedipine 10 mg tablet orally and intravenous placebo saline injection (up to 5 doses) or regimen (B) intravenous labetalol injection (at escalating dose regimen of 20 mg, 40 mg, 80 mg 80 mg and 80 mg) and a placebo tablet, repeated every 15 minutes until target blood pressure less than or equal to 150/100 mmHg is achieved.
Crossover treatment is carried out if the target blood pressure is not achieved after completion of the allocated regimen. Total duration of treatment is up to 2.5 hours and maximum follow up is at hospital discharge after delivery of the baby.
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Primary outcome measure(s)
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The time taken to achieve target systolic blood pressure less than or equal to 150 mmHg and diastolic blood pressure less than or equal to 100 mmHg, measured at no later than 3 hours after commencement of treatment
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Secondary outcome measure(s)
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1. Number of drug doses required to achieve target pressure less than or equal to 150/100 mmHg
2. Blood pressure profile during study period (a minimum of 1 hour from study drug administration or time taken to achieve target blood pressure whichever is the longer)
3. Maternal pulse profile during study period
4. Cardiotocogram abnormality
5. Maternal hypotension (blood pressure less than 90/60 mmHg)
6. Side effects profile by questionnaire at the end of the study period
7. Retreatment for hypertensive crises in 2 weeks following randomisation
Measurements not later than at hospital discharge following delivery of the baby.
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Sources of funding
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University of Malaya (Malaysia)
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Trial website
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Publications
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1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21985500
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Contact name
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Dr
Rahmah
Saaid
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Address
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Department of Obstetrics and Gynaecology
Faculty of Medicine
University of Malaya
Lembah Pantai
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City/town
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Kuala Lumpur
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Zip/Postcode
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50603
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Country
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Malaysia
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Sponsor
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University of Malaya Medical Centre (Malaysia)
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Address
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Department of Obstetrics and Gynaecology
Lembah Pantai
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City/town
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Kuala Lumpur
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Zip/Postcode
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50603
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Country
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Malaysia
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Sponsor website:
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http://www.ummc.edu.my/
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Date applied
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01/02/2011
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Last edited
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31/01/2012
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Date ISRCTN assigned
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17/03/2011
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