Dilapan-S/Dilasoft E-Registry in Induction of Labor

Study Overview
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Brief Summary
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International Observational E-Registry on the use of DILAPAN-S® osmotic dilator / DILASOFT® osmotic dilator for cervical ripening prior to labour induction.

Detailed Description
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International Observational E-Registry to monitor current common clinical practice of use of Dilapan-S / Dilasoft for cervical ripening and following procedures of labour induction with the main focus on the duration of induced labor procedure .

Official Title
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International Observational E-Registry on the Use of Dilapan-S / Dilasoft Osmotic Dilators for Cervical Ripening Prior to Labour Induction

Conditions
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Labour Onset and Length Abnormalities, Labor; Forced or Induced, Affecting Fetus or Newborn

Intervention / Treatment
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* Device: Dilapan-S


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for induction of labor Unfavourable cervix Exclusion Criteria: Presence of overt genital tract infection
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, Dilasoft for cervical ripening prior to induction of labor in women with unfavourable cervix|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Dilapan-S/Dilasoft insertion | duration of cervical ripening | max. up to 24 hrs; estimated average 12 hrs) | 
| Induction - delivery interval | Overall duration of induced labor procedure | estimated maximum up to 72 hrs | 
| Rate of vaginal deliveries within 24 hours | Rate of vaginal deliveries achieved within 24 hours from the beginning of induced labor procedure | up to 24 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of osmotic dilator used: Dilapan-S or Dilasoft |  | up to 24 hrs; estimated average 12 hrs | 
| Number of dilators inserted |  | up to 24 hrs; estimated average 12 hrs | 
| Bishop Score increase after extraction of osmotic dilators |  | up to 24 hrs; estimated average 12 hrs | 
| Complications during pre-induction | uterine contractions, uterine hypersensitivity, effect on the foetus | up to 24 hrs; estimated average 12 hrs | 
| Agents / procedures used for induction of labour, if any | which, total dosage | estimated maximum up to 72 hrs | 
| % of spontaneous vaginal deliveries following immediately after pre-induction |  | up to 24 hrs | 
| % of total spontaneous vaginal deliveries |  | estimated maximum up to 72 hrs | 
| % of instrumented vaginal deliveries |  | estimated maximum up to 72 hrs | 
| % of Caesarean sections |  | estimated maximum up to 72 hrs | 
| Foetal status | Apgar score at 0, 5 and 10 minutes after delivery, venous and arterial cord pH and base excess measurements | 0, 5 and 10 minutes after delivery (estimated maximum up to 72 hrs) | 
| Maternal infectious complication and its relation to the use of Dilapan-S/Dilasoft | Clinical signs of maternal infection found at patient´s examination are defined as follows: Body temperature > 37.8°C Increased pain Other overt clinical signs of infection e.g. vaginal discharge Laboratory test results that need to be correlated with clinical signs of infection: CRP levels > 8 mg/l Leukocyte count > 18 x 109/l Positive microbiological testing | up to 72 hrs; Complications, if any, will be followed-up until stable situation has been reached. | 
| Neonatal infectious complication and its relation to the use of Dilapan-S/Dilasoft | Clinical signs of neonatal infection found at patient´s examination are defined as follows: Body temperature > 37.8°C Increased pain Other overt clinical signs of infection e.g. vaginal discharge Laboratory test results that need to be correlated with clinical signs of infection: CRP levels > 8 mg/l Leukocyte count > 18 x 109/l Positive microbiological testing | 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