Randomised controlled trial on the use of Synthetic Osmotic cervical dilator in induction of Labour in comparison to dinoprostone Vaginal insErt: SOLVE

THE MAIN TRIAL FEATURES:

  • A randomised controlled trial.
  • The manufacturer of DILAPAN-S (Medicem) is funding the research.
  • Led by Prof Janesh Gupta (Chief Investigator).
  • Taking place at the following sites.
  • Birmingham Clinical Trials Unit at the University of Birmingham will be overseeing the administrative side of the Trial.
  • It is hoped that 860 patients will be recruited over a 36 month period beginning in December 2017.
  • Participating women will be randomly allocated to either Propess pessary OR Dilapan-S device for induction of labour.
  • The primary outcome will be the proportion of women, in each arm, that go on to have a successful vaginal delivery.
  • Patients will receive a Maternal Satisfaction questionnaire to complete during their admission, but will not need to be followed up after discharge.
  • The Trial is designed to fit in with routine hospital practice as far as possible.

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