Hypertension in pregnancy Pregnancy and Childbirth Gestational [pregnancy-induced] hypertension
Conditions
Interventions
24-hour ambulatory blood pressure monitoring, occuring up to three times in the pregnancy. Urine and blood samples will be collected up to four times in pregnancy. Urinary drug metabolite analysis wil
Sponsors
University of Birmingham
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women will be approached for recruitment to the BABY PANDA study after they have agreed to participate in the GIANT PANDA study (either randomised within the intervention study or participating in the observational arm) 2. Pregnancy =34+6 weeks’ gestation 3. Diagnosis of pregnancy hypertension (chronic or gestational hypertension) 4. Aged 18 years or over 5. Able to give informed consent
Exclusion criteria
Exclusion criteria: Diagnosis of preeclampsia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The principal outcome is 8-hour systolic BP post-dose response to labetalol/nifedipine. This is defined as the proportion of systolic BP readings =140 mmHg/number of BP readings within that time period. The post-dose 8-hour response window will begin at the time of the ingestion of the antihypertensive agent, within the 24-hour ambulatory BP monitoring episode (as captured by the participant's self-reported diaries). The time of the first dose will be classified as timepoint 0. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure: 1. 8-hour diastolic BP post-dose response to labetalol/nifedipine (defined as the proportion of diastolic BP readings =90 mmHg/number of BP readings, where the 8-hour post-dose window is defined as per the primary outcome) 2. 8-hour BP post-dose response to labetalol/nifedipine (defined as the proportion of BP readings =140 mmHg systolic or =90 mmHg diastolic/number of BP readings, where the 8-hour post-dose window is defined as per the primary outcome) 3. 8-hour BP post-dose variability expressed as reading to reading variability and standard deviation 4. 8-hour post-dose mean arterial pressure (MAP) 5. 8-hour post-dose mean maternal heart rate (HR) 6. 8-hour BP response (systolic, diastolic, proportion of readings =140 mmHg systolic or =90 mmHg diastolic/number of BP readings, and BP variability described for women on combination therapy (labetalol and nifedipine or another antihypertensive agent). 7. 24-hour post-dose systolic BP response to antihypertensive agent: the proportion of systolic BP readings =140 mmHg/number of BP readings 8. 24-hour post-dose diastolic, combined and BP response to antihypertensive agent: the proportion of diastolic BP readings =90 mmHg/number of BP readings. 9. 24-hour post-dose BP response to antihypertensive agent: the proportion of BP readings =140 mmHg systolic or =90 mmHg diastolic/number of BP readings. 10. 24-hour post-dose BP variability 11. 24-hour post-dose mean arterial pressure (MAP) 12. 24-hour post-dose mean maternal heart rate (HR) Blood and urine samples: 1. Adherence to medication measured using urinary drug metabolite concentrations at various timepoints across gestation 2. Renin and aldosterone concentrations measured using blood and urine samples at various timepoints across gestation | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed