International Observational E-Registry on the use of DILAPAN-S® osmotic dilator / DILASOFT® osmotic dilator for cervical ripening prior to labour induction.
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 .
Study Type
OBSERVATIONAL
Enrollment
444
Synthetic osmotic dilators Dilapan-S, Dilasoft for cervical ripening prior to induction of labor in women with unfavourable cervix
Bellevue Hospital
New York, New York, United States
University of Texas Medical Branch Galveston
Galveston, Texas, United States
Masaryk University
Brno, Czechia
Duration of Dilapan-S/Dilasoft insertion
duration of cervical ripening
Time frame: max. up to 24 hrs; estimated average 12 hrs)
Induction - delivery interval
Overall duration of induced labor procedure
Time frame: 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
Time frame: up to 24 hrs
Type of osmotic dilator used: Dilapan-S or Dilasoft
Time frame: up to 24 hrs; estimated average 12 hrs
Number of dilators inserted
Time frame: up to 24 hrs; estimated average 12 hrs
Bishop Score increase after extraction of osmotic dilators
Time frame: up to 24 hrs; estimated average 12 hrs
Complications during pre-induction
uterine contractions, uterine hypersensitivity, effect on the foetus
Time frame: up to 24 hrs; estimated average 12 hrs
Agents / procedures used for induction of labour, if any
which, total dosage
Time frame: estimated maximum up to 72 hrs
% of spontaneous vaginal deliveries following immediately after pre-induction
Time frame: up to 24 hrs
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vivantes Klinikum im Friedrichshain
Berlin, Germany
Buerger Hospital
Frankfurt am Main, Germany
Guru Teg Bahadur Hospital
New Delhi, National Capital Territory of Delhi, India
Sri Ramachandra Medical Center
Chennai, Tamil Nadu, India
Fernandez Hospital
Hyderabad, Telangana, India
Federal State Budget Institution "Research Center for Obstetrics, Gynecology and Perinatology" of the Ministry of Healthcare of Russian Federation
Moscow, Russia
University Hospital Trnava
Trnava, Slovakia
...and 1 more locations
% of total spontaneous vaginal deliveries
Time frame: estimated maximum up to 72 hrs
% of instrumented vaginal deliveries
Time frame: estimated maximum up to 72 hrs
% of Caesarean sections
Time frame: 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
Time frame: 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: 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
Time frame: 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: 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
Time frame: up to 72 hrs; Complications, if any, will be followed-up until stable situation has been reached.