Changes in the vaginal pressure profile during pregnancy & postpartum

• Research type

  Research Study

• Full title

  A pilot study to evaluate changes in the vaginal pressure profile during pregnancy and postpartum, using a novel intra-vaginal pressure sensing device (IVPSD).

• IRAS ID

  281084

• Contact name

  Swati Jha

• Contact email

  swati.jha1@nhs.net

• Sponsor organisation

  Sheffield Teaching Hospitals NHS Foundation Trust

• Duration of Study in the UK

  2 years, 6 months, 0 days

• Research summary

  To determine changes in the vaginal pressure profile throughout pregnancy and the postnatal period using a novel intra-vaginal pressure sensor device (IVPSD). Pregnant patients will be recruited to the study and have 4 vaginal pressure measurements obtained as well as two vaginal examinations for pelvic floor strength and signs of prolapse. They will also complete an online questionnaire to assess their pelvic floor symptoms at the first and fourth appointment. The fifth visit for IVPSD measurement, vaginal examination and questionnaire completion is optional.
  The changes in vaginal pressure profile throughout pregnancy will be observed to determine what effect pregnancy and delivery has on the pelvic floor.

• REC name

  Yorkshire & The Humber - South Yorkshire Research Ethics Committee

• REC reference

  20/YH/0187

• Date of REC Opinion

  24 Jul 2020

• REC opinion

  Further Information Favourable Opinion