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

Completed

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

• Registration Number: NCT02318173
• Lead Sponsor: Medicem International CR s.r.o.

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 .

Study Timeline

• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-17
• Study Start: 2015-05
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-18
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 444

Inclusion Criteria

• Indication for induction of labor
• Unfavourable cervix

Exclusion Criteria

• Presence of overt genital tract infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
% of Caesarean sections	estimated maximum up to 72 hrs
Bishop Score increase after extraction of osmotic dilators	up to 24 hrs; estimated average 12 hrs
% of instrumented vaginal deliveries	estimated maximum up to 72 hrs
Number of dilators inserted	up to 24 hrs; estimated average 12 hrs
Agents / procedures used for induction of labour, if any	estimated maximum up to 72 hrs	which, total dosage
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
Complications during pre-induction	up to 24 hrs; estimated average 12 hrs	uterine contractions, uterine hypersensitivity, effect on the foetus
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
Type of osmotic dilator used: Dilapan-S or Dilasoft	up to 24 hrs; estimated average 12 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
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

Trial Locations

Locations (11)

Fernandez Hospital; 🇮🇳 Hyderabad, Telangana, India

University Hospital Trnava; 🇸🇰 Trnava, Slovakia

Sri Ramachandra Medical Center; 🇮🇳 Chennai, Tamil Nadu, India

Guru Teg Bahadur Hospital; 🇮🇳 New Delhi, Delhi, India

Federal State Budget Institution "Research Center for Obstetrics, Gynecology and Perinatology" of the Ministry of Healthcare of Russian Federation; 🇷🇺 Moscow, Russian Federation

Birmingham Women´s Hospital; 🇬🇧 Birmingham, West Midlands, United Kingdom

Masaryk University; 🇨🇿 Brno, Czechia

Vivantes Klinikum im Friedrichshain; 🇩🇪 Berlin, Germany

Buerger Hospital; 🇩🇪 Frankfurt am Main, Germany

Bellevue Hospital; 🇺🇸 New York, New York, United States

University of Texas Medical Branch Galveston; 🇺🇸 Galveston, Texas, United States