VRAMMT Study

• Research type

  Research Study

• Full title

  A novel vaginal ring device offering automated monitoring of maternal core temperature for earlier determination of chorioamnionitis associated with preterm pre-labour rupture of membranes

• IRAS ID

  251240

• Contact name

  Fionnuala Mone

• Contact email

  f.mone@bham.ac.uk

• Sponsor organisation

  Belfast Health and Social Care Trust

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  Chorioamnionitis is a major cause of spontaneous preterm birth, accounting for more than 40% of deliveries complicated by preterm pre-labour rupture of membranes (PPROM) or preterm delivery. In the majority of cases, chorioamnionitis is caused by ascending polymicrobial infection. An early clinical sign of infection is increased maternal temperature. Routine expectant antenatal management of PPROM currently includes periodic measurement of maternal temperature using a conventional oral, tympanic or axilla thermometer.

  In this highly multidisciplinary project, we propose to test the concept that a novel vaginal ring device – made from medical grade silicone elastomer and containing an embedded miniature temperature logger – can offer continuous, real-time, monitoring of maternal temperature and may be useful for early detection of chorioamnionitis while being acceptable to pregnant women.

• REC name

  HSC REC A

• REC reference

  20/NI/0142

• Date of REC Opinion

  7 May 2021

• REC opinion

  Further Information Favourable Opinion