Dilapan-S/Dilasoft E-Registry in Induction of Labour

• Research type

  Research Study

• Full title

  International Observational E-Registry on the use of Dilapan-S/Dilasoft osmotic dilators for cervical ripening prior to labour induction

• IRAS ID

  167015

• Contact name

  Daniela Gdovinova

• Contact email

  daniela.gdovinova@medicem.com

• Sponsor organisation

  MEDICEM International s.r.o

• Clinicaltrials.gov Identifier

  NCT02318173

• Clinicaltrials.gov Identifier

  15/WM/0030, REC application reference number; NCT02318173, clinicaltrials.gov

• Duration of Study in the UK

  0 years, 11 months, 31 days

• Research summary

  This study is designed to monitor the post market clinical practice of using either the Dilapan-S and the Dilasoft osmotic dilator to prepare the neck of womb (cervix) for delivery.
  This is an international, multi-centre, observational study which involves the collection of data on two CE marked products.
  Informed consent will be obtained from the Patients who are identified for pre-induction and anonymous data will be collected by the research team. These data will be analysed to observe the clinical practice of use of Dilapan-S and Dilasoft. The main focus of the data analysis will be on the duration of cervical ripening, overall duration of induced labour procedure and the rate of vaginal deliveries within 24 hours

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  15/WM/0098

• Date of REC Opinion

  10 Apr 2015

• REC opinion

  Further Information Favourable Opinion