Dilapan-S / Dilasoft E-Registry in Induced Abortion

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

Detailed Description
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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.

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

Conditions
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Abortion, Induced

Intervention / Treatment
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* Device: Dilapan-S


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Dilapan-S|Synthetic osmotic dilators Dilapan-S or Dilasoft for cervical priming prior to induced abortion|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of inserted osmotic dilators |  | max. up to 24 hrs; estimated average 6 hrs | 
| Total time taken for cervical priming with Dilapan-S/Dilasoft | 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 | Dilapan-S or Dilasoft | max. up to 24 hrs; estimated average 6 hrs | 
| Complications during cervical priming | 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 |  | up to 24 hrs; estimated average 6 hrs | 
| Need of additional mechanical dilation | In cases, when surgical abortion is performed | up to 10 minutes after osmotic dilators extraction | 
| Surgical operative time | Period from speculum insertion in to speculum extraction out | estimated max. up to 10 min, estimated average 8 min. | 
| Initiation-to-delivery time | In case of medical abortion | hrs | 
| Induction-to-delivery time | In case of medical abortion | up to 72 hrs; estimated average 48 hrs | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical dilatation