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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medicem International CR s.r.o.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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