Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
738.15
Study information
Scientific title
Oral nifedipine versus intravenous labetalol hydrochloride for acute blood pressure control in hypertensive emergencies of pregnancy: a double blind randomised clinical trial
Acronym
ONILHEP
Study hypothesis
Oral nifedipine has a more rapid effect on blood pressure in a hypertensive emergency of pregnancy compared to intravenous labetalol hydrochloride.
Ethics approval
University of Malaya Medical Centre Medical Ethics Committee approved on the 8th September 2009 (ref: 738.15)
Study design
Double blind randomised clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Severe hypertension of pregnancy
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Nifedipine, labetalol hydrochloride
Primary outcome measure
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
Secondary outcome measures
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.
Overall trial start date
02/01/2010
Overall trial end date
18/10/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
50 in total
Participant exclusion criteria
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
Recruitment start date
02/01/2010
Recruitment end date
18/10/2010
Locations
Countries of recruitment
Malaysia
Trial participating centre
Department of Obstetrics and Gynaecology
Kuala Lumpur
50603
Malaysia
Sponsor information
Organisation
University of Malaya Medical Centre (Malaysia)
Sponsor details
Department of Obstetrics and Gynaecology
Lembah Pantai
Kuala Lumpur
50603
Malaysia
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Malaya (Malaysia)
Alternative name(s)
University of Malaya, UM
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Malaysia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21985500
Publication citations
-
Results
Raheem IA, Saaid R, Omar SZ, Tan PC, Oral nifedipine versus intravenous labetalol for acute blood pressure control in hypertensive emergencies of pregnancy: a randomised trial., BJOG, 2012, 119, 1, 78-85, doi: 10.1111/j.1471-0528.2011.03151.x.