Dilapan-S / Dilasoft E-Registry in Induced Abortion (DSREGISTRYIA)

Medicem

Status: Completed

Conditions: Abortion, Induced

Treatments: Device: Dilapan-S

Study type: Observational

Funder types: Industry

Identifiers

NCT02318212

DIS-2014-010

Details and patient eligibility

About

International Observational E-Registry on the use of osmotic dilators DILAPAN-S® / DILASOFT® for cervical priming prior to induced abortion.

Full description

International, multicentre, non-interventional, observational e-registry, post market clinical follow up study to document current clinical use of Dilapan-S or Dilasoft for cervical priming before induced abortion with regard to the number of dilators used, duration of insertion of dilators in situ and unusual complications consequent of their use.

Enrollment: 439 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Intrauterine pregnancy ≥ 6 and ≤ 24 weeks gestation
• Patients who are capable of giving consent and sign the form
• Abortion being made in compliance with the Abortion Act 1967 (For England, Wales and Scotland)

Exclusion criteria

• Clinical signs of uterine, vaginal or vulvar infection
• Acute bleeding