Home Blood Pressure Recording in Pregnancy - A Pilot Study for a Randomised Trial
| ISRCTN | ISRCTN20643323 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20643323 |
| Protocol serial number | HSR/037 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Northern and Yorkshire (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 21/01/2010
- 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
Prof Jenny Hewison
Scientific
Scientific
Academic Unit of Psychiatry and Behavioural Sciences
University of Leeds
15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom
| Phone | +44 (0)113 343 1894 |
|---|---|
| j.hewison@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The traditional model of antenatal care often involves 14 or more clinical visits but there is large practice variation. The detection of hypertension is an important function of antenatal care and, unless blood pressure can be monitored outside the clinic, this sets a lower limit on the frequency of visits. We propose a pilot study (prior to embarking on a larger trial) where women would be randomised to receive EITHER routine antenatal visits and clinic monitoring of blood pressure OR a reduced number of antenatal visits and home monitoring of blood pressure. The pilot will investigate what proportion and types of women are willing to take part in such a study and whether women use portable blood pressure monitors satisfactorily and at the prescribed times. It will also be sufficient to measure major effects on anxiety and number of attendances. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy and hypertension |
| Intervention | 1. Routine antenatal visits and clinic monitoring of blood pressure 2. A reduced number of antenatal visits and home monitoring of blood pressure. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Recruitment |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 24/09/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 80 |
| Key inclusion criteria | Pregnant women |
| Key exclusion criteria | 1. Multiple pregnancies 2. Established hypertension 3. Previous early-onset pre-eclampsia 4. Serious medical disease 5. Previous pregnancy loss after 24 weeks |
| Date of first enrolment | 25/03/1996 |
| Date of final enrolment | 24/09/1997 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Academic Unit of Psychiatry and Behavioural Sciences
Leeds
LS2 9LT
United Kingdom
LS2 9LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/02/2000 | Yes | No |
