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

May 18, 2017 updated by: Medicem International CR s.r.o.

International Observational E-Registry on the Use of Dilapan-S/Dilasoft Osmotic Dilators for Cervical Priming Prior to Induced Abortion

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

439

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

All patients indicated for cervical priming with Dilapan-S or Dilasoft prior to induced abortion and meet all inclusion and exclusion criteria in centres involved in data collection.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicem International CR s.r.o.

Investigators

  • Principal Investigator: Patricia Lohr, MD, British Pregnancy Advisory Service, UK
  • Principal Investigator: Jiri Hanacek, MD, Institute of Care for Mother and Child, Prague, CZ
  • Principal Investigator: Natalia Kan, Prof., MD, Research Center for Obstetrics, Gynecology and Perinatology, Moscow
  • Principal Investigator: John Roizin, MD, Allentown Women´s Center, Bethlehem, PA, US
  • Principal Investigator: Mary Jane Bovo, MD, Choices Women´s Medical Center, New York
  • Principal Investigator: LeRoy Carhart, MD, Germantown Reproductive Health Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 9, 2014

First Submitted That Met QC Criteria

December 11, 2014

First Posted (Estimate)

December 17, 2014

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 18, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DIS-2014-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Abortion, Induced

Clinical Trials on Dilapan-S

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe