Dilapan-S / Dilasoft E-Registry in Induced Abortion

Medicem International CR s.r.o.439 enrolled

Overview

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

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

439

Conditions

Abortion, Induced

Interventions

Dilapan-SDEVICE

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

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of inserted osmotic dilators

Time frame: 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

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

Secondary Outcomes

Type of synthetic osmotic dilator used

Dilapan-S or Dilasoft

Time frame: 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

Time frame: 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

Need of additional mechanical dilation

In cases, when surgical abortion is performed

Time frame: up to 10 minutes after osmotic dilators extraction

Surgical operative time

Period from speculum insertion in to speculum extraction out

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

Initiation-to-delivery time

In case of medical abortion

Time frame: hrs

Induction-to-delivery time

Data from ClinicalTrials.gov

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