Dilapan-S / Dilasoft E-Registry in Induced Abortion

Completed

• Conditions: Abortion, Induced

• Registration Number: NCT02318212
• Lead Sponsor: Medicem International CR s.r.o.

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-17
• Study Start: 2015-03
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-18
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 439

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of inserted osmotic dilators	max. up to 24 hrs; estimated average 6 hrs
Total time taken for cervical priming with Dilapan-S/Dilasoft	max. up to 24 hrs; estimated average 6 hrs	Duration of leaving osmotic dilators in situ

Secondary Outcome Measures

Name	Time	Method
Type of synthetic osmotic dilator used	max. up to 24 hrs; estimated average 6 hrs	Dilapan-S or Dilasoft
Complications during cervical priming	up to 24 hrs; estimated average 6 hrs	pre-operative bleeding, fever, pain, nausea, vomiting, diarrhoea, premature passage of foetal or chorionic tissue
Other observed undesirable effects uf use of synthetic osmotic dilators	up to 24 hrs; estimated average 6 hrs
Need of additional mechanical dilation	up to 10 minutes after osmotic dilators extraction	In cases, when surgical abortion is performed
Surgical operative time	estimated max. up to 10 min, estimated average 8 min.	Period from speculum insertion in to speculum extraction out
Initiation-to-delivery time	hrs	In case of medical abortion
Induction-to-delivery time	up to 72 hrs; estimated average 48 hrs	In case of medical abortion
Complications related to induced abortion procedure	up to 24 hrs; estimated average 12 hrs
Infectious complication and its relation to the use of Dilapan-S/Dilasoft	up to 72 hrs; Complications, if any, will be followed-up until stable situation has been reached.