Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and Sexual Medicine
Conditions
Interventions
Treatment across arms are double blinded with only the trial pharmacist at site and randomising statistician being unblinded. Randomisation is done via a secure web based system and is performed by a
Sponsors
Central Manchester University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Viable singleton pregnancy 2. Gestation: 12+0 to 16+0 weeks 3. Aged 18 years or over 4. Able to provide informed consent 5. Diastolic BP of =90 mmHg (average of two clinic readings) OR =80 mmHg if taking antihypertensive medication OR PWV =9m/s before 16 weeks’ gestation 6. Serum creatinine <120 mmol/l at booking
Exclusion criteria
Exclusion criteria: There is no exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate is measured by number of women recruited and completing study per month 2. Change in diastolic blood pressure (from baseline to 8 weeks post randomisation following L- citrulline supplementation, compared with placebo – Change in clinic diastolic BP (average of 3 readings) will be calculated at baseline and week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acceptability of intervention in pregnant women with chronic hypertension is measured by number of women completing treatment and completion of participant questionnaire at end of the treatment period 2. The following results are compared within treatment groups only (paired analysis) as the study is not sufficiently powered to identify a difference between randomised groups: 2.1. Average day and night time Ambulatory Blood Pressure Measurements (ABPM.) ABPM measurements will be downloaded from the software (SpaceLabs) and the day and night time averages calculated by the software. 2.2. Pulse wave velocity measurements will be exported from the Tensioclinic software. Vascular compliance measurements including central BP, pulse wave velocity, augmentation index will be compared within groups. 2.3. Peripheral vascular resistance measurements obtained from the NICOM. Measurements of cardiac output, cardiac index, SVI and TPRI will be compared within groups. 2.4. Uteroplacental blood flow measurements: uterine artery resistance index (RI) and pulsatility index (PI), presence/absence of notching 2.5. Plasma ADMA/arginine concentrations 2.6. Change in antihypertensive therapy | — |
Countries
England, United Kingdom
Contacts
Public ContactSophie Hennessy
Outcome results
None listed