Dilapan-S / Dilasoft E-Registry in Termination of Pregnancy
Research type
Research Study
Full title
International Observational E-Registry on the use of Dilapan-S/Dilasoft osmotic dilators in cervical dilation prior to termination of pregnancy
IRAS ID
166840
Contact name
Daniela Gdovinova
Contact email
Sponsor organisation
MEDICEM International
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
15/WM/0031, REC application reference number; NCT02318212, clinicaltrials.gov
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
This study is designed to document current clinical use of Dilapan-S or Dilasoft for cervical priming prior to induced abortion with regard to the number of dilators used and duration of insertion of dilators in situ.
This is an international, multicentre, nonintervention, 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 cervical priming and anonymous data will be collected by the research team. These data will be analysed to find out the current common clinical practice of use of
Dilapan-S and Dilasoft. The main focus of the data analysis will be on the duration of cervical priming and the number of dilators used.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
15/WM/0099
Date of REC Opinion
8 Apr 2015
REC opinion
Further Information Favourable Opinion