Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive health and childbirth (migration) Pregnancy and Childbirth Chronic hypertension in pregnancy
Conditions
Interventions
Pregnant women with chronic hypertension will be randomised 2:1 intervention to usual care using a secure web-based system, with allocation stratified for study site.
Control group: Participants rece
Sponsors
University of Oxford Clinical Trials and Research Governance Team
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with chronic hypertension (defined as sustained diastolic BP=90 mmHg and/or systolic BP=140 mmHg, present at booking or before 20 weeks gestation, or receiving treatment outside pregnancy and/or at time of referral) 2. Recruited at booking 23+6 weeks gestation 3. Viable singleton pregnancy 4. Willing to be randomised 5. Able to give informed written consent 6. Aged 18 years and over
Exclusion criteria
Exclusion criteria: 1. Unwilling to selfmonitor 2. Insufficient understanding of the study 3. Confirmed superimposed preeclampsia (as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP) 2014 statement) before recruitment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate is determined at the end of the study period by recording the number of participants recruited per site per month, including as proportion of those who were approached and eligible 2. Loss to follow up is determined at the end of the study period by recording the number lost to follow-up after delivery/number of participants recruited 3. Withdrawal rate is determined at the end of the study period by recording the number of participants withdrawing consent/number of participants recruited 4. Adherence and persistence with BP self-monitoring protocol is determined as the proportion of intervention participants completing no home BP measurements (total and by week) at the end of the study period 5. Acceptability of randomisation is determined at the end of the study period by recoridng the proportion of participants citing randomisation as reason for non-participation and the proportion in usual care arm starting home BP monitoring post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood pressure control measured using: 1.1. Highest systolic blood pressure recorded between randomisation and delivery, excluding day of delivery 1.2. Average systolic blood pressure recorded between randomisation and delivery, excluding day of delivery (calculated using trapezium method applied to area under the curve) 1.3. Proportion developing systolic BP >=150 mmHg, and diastolic BP >=100 mmHg, recorded between randomisation and delivery, excluding day of delivery 2. Antihypertensive medication adherence measured using: 2.1. MARS and BMQ questionnaire score differences measured at 20, 28 and 34 weeks gestation 2.2. Defined Daily Dose of oral antihypertensive medication measured at 20, 28 and 34 weeks gestation 3. Maternal outcomes including: 3.1. Morbidity or mortality (pre-eclampsia, eclampsia, intracranial haemorrhage/infarct, myocardial ischaemia/infarction, intubation, pulmonary oedema, hepatic dysfunction, acute kidney injury, neurological dysfunction other than stroke (altered GCS, blindness, hyperreflexia + clonus, severe headache +hyperreflexia, persistent visual scotoma), disseminated intravascular coagulation, HELLP syndrome (haemolysis, elevated liver enzymes, low platelets), placental abruption, post-partum haemorrhage), all assessed on final maternal discharge after delivery 3.2. Gestation at delivery (assessed at delivery) 3.3. Mode of delivery (assessed at delivery) 3.4. Indication for delivery (assessed at delivery 4. Perinatal outcomes including: 4.1. Neonatal mortality or stillbirth (assessed at time of death) 4.2. Neonatal morbidity (including admission to neonatal unit: LDC, HDU, ICU; respiratory distress syndrome, need for ventilator support) all assessed on discharge of infant 4.3. Prematurity and small-for-gestational-age (assessed at delivery) 5. Health resource use outcomes including: 5.1. Number and cost of clinical contacts (antenatal attendances to clinic and day unit) and admissions and their timing for out-of-range BP readings a | — |
Countries
England, United Kingdom
Outcome results
None listed