The PREDIcT Study

• Research type

  Research Study

• Full title

  Predicting PREterm birth anD PPROM after surgical Intervention in Twin pregnancy

• IRAS ID

  265280

• Contact name

  Diane Lambo

• Contact email

  diane.lambo@nhs.net

• Sponsor organisation

  University College London

• Clinicaltrials.gov Identifier

  Z6364106/0000/00/00, UCL Data Protection Registration number

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  Preterm birth (PTB) is the leading cause of childhood disability below the age of 5 worldwide, and is the most common complication affecting twin pregnancy. Twins most at risk of PTB are those affected by twin-twin transfusion syndrome (TTTS). Untreated, the survival rate of TTTS for the baby is as low as 7%. Fetal laser surgery inside the womb increases this survival to 74%, but it is associated with a dramatic increase in PTB; as many as 8 in 10 deliver preterm. At present we are not able to identify twins most at risk of PTB following invasive procedures. We know infection causes approximately 40% of PTB in singleton pregnancy, but are uncertain of its role in twins.
  In this study, using advanced technologies we aim to evaluate the role of genitourinary infection in PTB among twins undergoing surgical interventions. We also aim to improve our current ability to identify twins at risk through investigating the current clinical tools used to screen for PTB. These include ultrasound measurement of the cervix (cervical length) and fetal Fibronectin (a protein in vaginal fluid), both of which have not been tested in twins undergoing surgical interventions. The study will take place across four specialist Fetal Medicine centers in London. Recruited participants will be invited for measurements of cervical length, fetal fibronectin, and samples of urine and vaginal fluid at three time-points in pregnancy, (before and after surgical intervention). We will take note of the outcome of the participant’s pregnancy, specifically the gestation at which their babies are born. The aim of the study will be to investigate cervical length, fetal Fibronectin and genito-urinary infection for their combined predictive capacity for PTB in these very high risk pregnancies. In doing so we hope to improve selection of pregnancies likely to benefit from invasive procedures.

• REC name

  North West - Greater Manchester West Research Ethics Committee

• REC reference

  19/NW/0525

• Date of REC Opinion

  2 Aug 2019

• REC opinion

  Favourable Opinion