Oral Nifedipine versus Intravenous Labetalol hydrochloride for acute blood pressure control in Hypertensive Emergencies of Pregnancy

ISRCTN	ISRCTN78140744
DOI	https://doi.org/10.1186/ISRCTN78140744
Protocol serial number	738.15
Sponsor	University of Malaya Medical Centre (Malaysia)
Funder	University of Malaya (Malaysia)

Submission date: 01/02/2011
Registration date: 17/03/2011
Last edited: 31/01/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Rahmah Saaid
Scientific

Department of Obstetrics and Gynaecology
Faculty of Medicine
University of Malaya
Lembah Pantai
Kuala Lumpur
50603
Malaysia

Study information

Primary study design	Interventional
Study design	Double blind randomised clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Oral nifedipine versus intravenous labetalol hydrochloride for acute blood pressure control in hypertensive emergencies of pregnancy: a double blind randomised clinical trial
Study acronym	ONILHEP
Study objectives	Oral nifedipine has a more rapid effect on blood pressure in a hypertensive emergency of pregnancy compared to intravenous labetalol hydrochloride.
Ethics approval(s)	University of Malaya Medical Centre Medical Ethics Committee approved on the 8th September 2009 (ref: 738.15)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Nifedipine, labetalol hydrochloride
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	18/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	50
Key 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
Key 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
Date of first enrolment	02/01/2010
Date of final enrolment	18/10/2010

Locations

Countries of recruitment

Malaysia

Study participating centre

Department of Obstetrics and Gynaecology

Kuala Lumpur
50603
Malaysia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes