Condition category
Pregnancy and Childbirth
Date applied
01/02/2011
Date assigned
17/03/2011
Last edited
31/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rahmah Saaid

ORCID ID

Contact details

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

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 measures

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

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

http://www.ummc.edu.my/

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21985500

Publication citations

  1. 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.

Additional files

Editorial Notes