Abortion, Induced
Conditions
Keywords
Cervical dilatation
Brief summary
International Observational E-Registry on the use of osmotic dilators DILAPAN-S® / DILASOFT® for cervical priming prior to induced abortion.
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.
Interventions
DEVICEDilapan-S
Synthetic osmotic dilators Dilapan-S or Dilasoft for cervical priming prior to induced abortion
Sponsors
Medicem International CR s.r.o.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of inserted osmotic dilators | max. up to 24 hrs; estimated average 6 hrs | — |
| Total time taken for cervical priming with Dilapan-S/Dilasoft | max. up to 24 hrs; estimated average 6 hrs | Duration of leaving osmotic dilators in situ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other observed undesirable effects uf use of synthetic osmotic dilators | up to 24 hrs; estimated average 6 hrs | — |
| Need of additional mechanical dilation | up to 10 minutes after osmotic dilators extraction | In cases, when surgical abortion is performed |
| Surgical operative time | estimated max. up to 10 min, estimated average 8 min. | Period from speculum insertion in to speculum extraction out |
| Type of synthetic osmotic dilator used | max. up to 24 hrs; estimated average 6 hrs | Dilapan-S or Dilasoft |
| Induction-to-delivery time | up to 72 hrs; estimated average 48 hrs | In case of medical abortion |
| 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. | — |
| Initiation-to-delivery time | hrs | In case of medical abortion |
| Complications during cervical priming | up to 24 hrs; estimated average 6 hrs | pre-operative bleeding, fever, pain, nausea, vomiting, diarrhoea, premature passage of foetal or chorionic tissue |
Outcome results
None listed