Severe hypertension of pregnancy Pregnancy and Childbirth Hypertension during pregnancy
Conditions
Interventions
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
Sponsors
University of Malaya Medical Centre (Malaysia)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Malaysia
Outcome results
None listed