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Completed

NCT Number: NCT02318212

Dilapan-S / Dilasoft E-Registry in Induced Abortion

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

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Key information

Conditions

Abortion, Induced

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dilapan-S

Device

Synthetic osmotic dilators Dilapan-S or Dilasoft for cervical priming prior to induced abortion

Other names: Dilasoft

Primary outcomes

  1. Number of inserted osmotic dilators

    Time frame: max. up to 24 hrs; estimated average 6 hrs

  2. 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

Secondary outcomes

  1. Type of synthetic osmotic dilator used

    Time frame: max. up to 24 hrs; estimated average 6 hrs

    Dilapan-S or Dilasoft

  2. 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

  3. Other observed undesirable effects uf use of synthetic osmotic dilators

    Time frame: up to 24 hrs; estimated average 6 hrs

  4. Need of additional mechanical dilation

    Time frame: up to 10 minutes after osmotic dilators extraction

    In cases, when surgical abortion is performed

  5. Surgical operative time

    Time frame: estimated max. up to 10 min, estimated average 8 min.

    Period from speculum insertion in to speculum extraction out

  6. Initiation-to-delivery time

    Time frame: hrs

    In case of medical abortion

  7. Induction-to-delivery time

    Time frame: up to 72 hrs; estimated average 48 hrs

    In case of medical abortion

  8. Complications related to induced abortion procedure

    Time frame: up to 24 hrs; estimated average 12 hrs

  9. 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.

Sponsors and collaborators

Lead sponsor

Medicem International CR s.r.o.

Industry

Registry information

Official study title

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

Acronym: DSREGISTRYIA

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2014
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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