CONCEIVE 2
Research type
Research Study
Full title
Pre-conception interventions to reduce blood pressure before pregnancy
IRAS ID
274808
Contact name
Christoph Lees
Contact email
Sponsor organisation
Imperial College NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 29 days
Research summary
Research Summary
High blood pressure in pregnancy affects up to 9% of pregnancies and is associated with premature delivery and stillbirth for the baby and seizures and strokes for mothers. In women affected, blood pressure usually returns to normal after pregnancy.Women with high blood pressure and women with blood pressure in the upper part of the normal range are at increased risk of high blood pressure in pregnancy.
There is evidence that women who develop high blood pressure in pregnancy have hearts which pump less effectively and blood pressures which are higher (whilst still in the normal range) both before and after pregnancies affected by high blood pressure.
We will test the feasibility of intervening before pregnancy to reduce women's blood pressure by asking women who are considering becoming pregnant in the future to undertake exercise and take beetroot juice, both of which are known to reduce blood pressure on their own. They will be allocated to different interventions at random.
If we identify that women are willing to undertake these ways of reducing blood pressure, we will use the results of this study to design a larger, randomised study to test whether high blood pressure in pregnancy can be reduced by intervening before pregnancy.
We will monitor participants' health and physical activity with a wearable and home blood pressure monitors and weighing scales throughout the study. We will also test their heart and circulation before and after the intervention(s).
Summary of Results
• There were no demographic differences between the four groups in the study. 29/32(90.6%) of participants completed the study.
• Exercise was associated with reduction in blood pressure and standing blood vessel resistance.
• No differences were observed for clinical blood pressure measurements.
• Beetroot juice was associated with a modest reduction in some measures of blood pressure.
• Exercise and beetroot juice together was associated with reduction in diastolic blood pressure and cardiac output.Discussion: The combination of exercise and beetroot juice are acceptable interventions in women prior to pregnancy; appearing to lower blood pressure and improve cardiovascular function. This is potentially important and these findings support a study to investigate their effect on the development of pre-eclampsia and related conditions.
REC name
London - Chelsea Research Ethics Committee
REC reference
20/LO/0068
Date of REC Opinion
2 Mar 2020
REC opinion
Further Information Favourable Opinion