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 |
| Secondary identifying numbers | 738.15 |
- 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
Scientific
Department of Obstetrics and Gynaecology
Faculty of Medicine
University of Malaya
Lembah Pantai
Kuala Lumpur
50603
Malaysia
Study information
| Study design | Double blind randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 02/01/2010 |
| Completion date | 18/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 50 in total |
| 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
50603
Malaysia
Sponsor information
University of Malaya Medical Centre (Malaysia)
University/education
University/education
Department of Obstetrics and Gynaecology
Lembah Pantai
Kuala Lumpur
50603
Malaysia
| Website | http://www.ummc.edu.my/ |
|---|---|
"ROR" |
https://ror.org/00vkrxq08 |
Funders
Funder type
University/education
University of Malaya (Malaysia)
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Malaya, University Malaya, Malayan University, UM
- Location
- Malaysia
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2012 | Yes | No |
