Labor; Forced or Induced, Affecting Fetus or Newborn, Labour Onset and Length Abnormalities
Conditions
Keywords
Cervical dilatation
Brief summary
International Observational E-Registry on the use of DILAPAN-S® osmotic dilator / DILASOFT® osmotic dilator for cervical ripening prior to labour induction.
Detailed description
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 .
Interventions
DEVICEDilapan-S
Synthetic osmotic dilators Dilapan-S, Dilasoft for cervical ripening prior to induction of labor in women with unfavourable cervix
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
* Indication for induction of labor * Unfavourable cervix
Exclusion criteria
* Presence of overt genital tract infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Dilapan-S/Dilasoft insertion | max. up to 24 hrs; estimated average 12 hrs) | duration of cervical ripening |
| Induction - delivery interval | estimated maximum up to 72 hrs | Overall duration of induced labor procedure |
| Rate of vaginal deliveries within 24 hours | up to 24 hrs | Rate of vaginal deliveries achieved within 24 hours from the beginning of induced labor procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications during pre-induction | up to 24 hrs; estimated average 12 hrs | uterine contractions, uterine hypersensitivity, effect on the foetus |
| Agents / procedures used for induction of labour, if any | estimated maximum up to 72 hrs | which, total dosage |
| % of spontaneous vaginal deliveries following immediately after pre-induction | up to 24 hrs | — |
| % of total spontaneous vaginal deliveries | estimated maximum up to 72 hrs | — |
| Type of osmotic dilator used: Dilapan-S or Dilasoft | up to 24 hrs; estimated average 12 hrs | — |
| % of Caesarean sections | estimated maximum up to 72 hrs | — |
| Foetal status | 0, 5 and 10 minutes after delivery (estimated maximum up to 72 hrs) | Apgar score at 0, 5 and 10 minutes after delivery, venous and arterial cord pH and base excess measurements |
| Maternal 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. | Clinical signs of maternal infection found at patient´s examination are defined as follows: 1. Body temperature \> 37.8°C 2. Increased pain 3. Other overt clinical signs of infection e.g. vaginal discharge Laboratory test results that need to be correlated with clinical signs of infection: 4. CRP levels \> 8 mg/l 5. Leukocyte count \> 18 x 109/l 6. Positive microbiological testing |
| Neonatal 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. | Clinical signs of neonatal infection found at patient´s examination are defined as follows: 1. Body temperature \> 37.8°C 2. Increased pain 3. Other overt clinical signs of infection e.g. vaginal discharge Laboratory test results that need to be correlated with clinical signs of infection: 4. CRP levels \> 8 mg/l 5. Leukocyte count \> 18 x 109/l 6. Positive microbiological testing |
| % of instrumented vaginal deliveries | estimated maximum up to 72 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 | — |
Countries
Czechia, Germany, India, Russia, Slovakia, United Kingdom, United States
Outcome results
None listed