NCT02482363

Vascular Responses to UV Exposure in Pregnancy

Completed NA Last updated 21 May 2024

What this trial tests

NA trial testing UVA radiation in Pregnancy in 19 participants. Completed in 31 March 2016.

Timeline

1 September 2015

Primary endpoint
31 March 2016

31 March 2016

Quick facts

Lead sponsor	University of Edinburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	19
Start date	1 September 2015
Primary completion	31 March 2016
Estimated completion	31 March 2016
Sites	1 location across United Kingdom

Drugs / interventions tested

• UVA radiation
• Sham Control — full drug profile →

Conditions studied

• Pregnancy — all drugs for Pregnancy →

Sponsor

University of Edinburgh

Who can join

Adults 18 to 45, female only, with Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Season of birth influences pregnancy for reasons that remain unclear however the answer may lie in the amount of sunshine pregnant women are exposed to. Sunshine, or ultraviolet light (UV) exposure is already known to have benefits for health on heart disease, strokes and depression. In pregnancy, relationships between sunshine exposure are evident in birth weight, preterm birth and risk of blood pressure complications. Vitamin D, the UV generated hormone, was thought to be responsible when low vitamin D levels were associated with these pregnancy complications. However, vitamin D replacement is ineffective at preventing these outcomes, and the investigators hypothesise that this is because it is the UV that is beneficial for pregnancy and it is working through a different pathway.

A new understanding of skin function is central to this, with a 2014 study showing that exposing an adult to 20 minutes of low dose UV light lowered their blood pressure and improved blood flow. These investigators demonstrated this was a direct effect of UV on the skin and was mediated by nitric oxide, a chemical central to many aspects of pregnancy including blood pressure regulation and uterine activity.

The investigators in this study have funding from Tommy's to investigate if a similar effect is seen in pregnancy on the circulation. The design is similar to the previously successful method and volunteers would be recruited from clinical areas during the second trimester. As both resting and warming for 20 minutes have the potential to have similar effects on the circulation, a control arm will expose participants to these without the UV.

This pilot study would involve one visit and measurements taken would include heart rate, blood pressure, arteriography, ultrasound of the uterine arteries and blood measurements of nitric oxide levels. Arteriography is performed using a specialised arm cuff and is safe and non-invasive. A subset of these women would be invited to repeat this in the third trimester to investigate for a difference in effect at a later gestation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.