USgHIFU-TTTS study
Research type
Research Study
Full title
Ultrasound-guided High Intensity Focused Ultrasound to treat Twin-Twin Transfusion Syndrome (USgHIFU-TTTS study)
IRAS ID
260359
Contact name
Christoph C Lees
Contact email
Sponsor organisation
Imperial College London
ISRCTN Number
ISRCTN33458649
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Approximately 4000 identical (monochorionic diamniotic, MCDA) twin pairs are born in the UK every year. Twin-Twin Transfusion Syndrome (TTTS) affects 10-15% of MCDA twins, and it is a leading cause of mortality, premature delivery and morbidity. Fetoscopic laser ablation (closing) of the abnormal blood vessel connections in the placenta, is an invasive procedure performed after 18 weeks gestation. With this treatment there are risks of preterm rupture of membranes, labour/miscarriage, infection and maternal complications. However, in up to 25% cases of TTTS, there is a need for treatment before 18 weeks.
High Intensity Focused Ultrasound (HIFU) is a non-invasive therapeutic technique, so may avoid these laser risks, and can be used before 18 weeks gestation. It uses precisely aimed ultrasound beams to destroy tissue within the body without damage to surrounding tissues or the need for surgery. We have previously used it to safely and effectively block blood flow in the vessels in sheep placentas.
In this research study we will use ultrasound-guided HIFU to treat TTTS diagnosed at less than 18 weeks. This is a first in human clinical study of using ultrasound-guided HIFU to selectively block abnormal blood vessel connections in the placentae of identical twins which cause TTTS.This study will be conducted at Queen Charlotte's and Chelsea Hospital, Imperial College NHS Trust, London, but participants will be referred from UK-wide NHS maternity hospitals.
REC name
London - Riverside Research Ethics Committee
REC reference
20/LO/0029
Date of REC Opinion
16 Jan 2020
REC opinion
Favourable Opinion