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

Labor; Forced or Induced, Affecting Fetus or Newborn Clinical Trial

— DSREGISTRYIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318173
• Other study ID #: DIS-2014-009
• Status: Completed
• Phase: N/A
• First received: December 9, 2014
• Last updated: May 18, 2017
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: Medicem International CR s.r.o.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Indication for induction of labor

• Unfavourable cervix

Exclusion Criteria:

• Presence of overt genital tract infection

Related Conditions & MeSH terms

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

Intervention

Device:
• Dilapan-S
Synthetic osmotic dilators Dilapan-S, Dilasoft for cervical ripening prior to induction of labor in women with unfavourable cervix

Locations

Country	Name	City	State
Czechia	Masaryk University	Brno
Germany	Vivantes Klinikum im Friedrichshain	Berlin
Germany	Buerger Hospital	Frankfurt am Main
India	Sri Ramachandra Medical Center	Chennai	Tamil Nadu
India	Fernandez Hospital	Hyderabad	Telangana
India	Guru Teg Bahadur Hospital	New Delhi	Delhi
Russian Federation	Federal State Budget Institution "Research Center for Obstetrics, Gynecology and Perinatology" of the Ministry of Healthcare of Russian Federation	Moscow
Slovakia	University Hospital Trnava	Trnava
United Kingdom	Birmingham Women´s Hospital	Birmingham	West Midlands
United States	University of Texas Medical Branch Galveston	Galveston	Texas
United States	Bellevue Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medicem International CR s.r.o.

Countries where clinical trial is conducted

United States,  Czechia,  Germany,  India,  Russian Federation,  Slovakia,  United Kingdom, 

References & Publications (9)

Chua S, Arulkumaran S, Vanaja K, Ratnam SS. Preinduction cervical ripening: prostaglandin E2 gel vs hygroscopic mechanical dilator. J Obstet Gynaecol Res. 1997 Apr;23(2):171-7. — View Citation

Cromi A, Ghezzi F, Uccella S, Agosti M, Serati M, Marchitelli G, Bolis P. A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter. Am J Obstet Gynecol. 2012 Aug;207(2):125.e1-7. doi: 10.1016/j.ajog.2012.05.020. Epub 2012 Jun 1. — View Citation

Jozwiak M, ten Eikelder M, Oude Rengerink K, de Groot C, Feitsma H, Spaanderman M, van Pampus M, de Leeuw JW, Mol BW, Bloemenkamp K; PROBAAT Study Group.. Foley catheter versus vaginal misoprostol: randomized controlled trial (PROBAAT-M study) and systematic review and meta-analysis of literature. Am J Perinatol. 2014 Feb;31(2):145-56. doi: 10.1055/s-0033-1341573. Epub 2013 Apr 5. — View Citation

Lichtenberg ES. Complications of osmotic dilators. Obstet Gynecol Surv. 2004 Jul;59(7):528-36. Review. — View Citation

Sanchez-Ramos L. Induction of labor. Obstet Gynecol Clin North Am. 2005 Jun;32(2):181-200, viii. Review. — View Citation

Sciscione AC, McCullough H, Manley JS, Shlossman PA, Pollock M, Colmorgen GH. A prospective, randomized comparison of Foley catheter insertion versus intracervical prostaglandin E2 gel for preinduction cervical ripening. Am J Obstet Gynecol. 1999 Jan;180(1 Pt 1):55-60. — View Citation

Suffecool K, Rosenn BM, Kam S, Mushi J, Foroutan J, Herrera K. Labor induction in nulliparous women with an unfavorable cervix: double balloon catheter versus dinoprostone. J Perinat Med. 2014 Mar;42(2):213-8. doi: 10.1515/jpm-2013-0152. — View Citation

Ten Eikelder ML, Neervoort F, Oude Rengerink K, van Baaren GJ, Jozwiak M, de Leeuw JW, de Graaf I, van Pampus MG, Franssen M, Oudijk M, van der Salm P, Woiski M, Pernet PJ, Feitsma AH, van Vliet H, Porath M, Roumen F, van Beek E, Versendaal H, Heres M, Mol BW, Bloemenkamp KW. Induction of labour with a Foley catheter or oral misoprostol at term: the PROBAAT-II study, a multicentre randomised controlled trial. BMC Pregnancy Childbirth. 2013 Mar 19;13:67. doi: 10.1186/1471-2393-13-67. Erratum in: BMC Pregnancy Childbirth. 2013;13:183. van Baaren, Gert J [added]. — View Citation

Tenore JL. Methods for cervical ripening and induction of labor. Am Fam Physician. 2003 May 15;67(10):2123-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Dilapan-S/Dilasoft insertion	duration of cervical ripening	max. up to 24 hrs; estimated average 12 hrs)
Primary	Induction - delivery interval	Overall duration of induced labor procedure	estimated maximum up to 72 hrs
Primary	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	Type of osmotic dilator used: Dilapan-S or Dilasoft		up to 24 hrs; estimated average 12 hrs
Secondary	Number of dilators inserted		up to 24 hrs; estimated average 12 hrs
Secondary	Bishop Score increase after extraction of osmotic dilators		up to 24 hrs; estimated average 12 hrs
Secondary	Complications during pre-induction	uterine contractions, uterine hypersensitivity, effect on the foetus	up to 24 hrs; estimated average 12 hrs
Secondary	Agents / procedures used for induction of labour, if any	which, total dosage	estimated maximum up to 72 hrs
Secondary	% of spontaneous vaginal deliveries following immediately after pre-induction		up to 24 hrs
Secondary	% of total spontaneous vaginal deliveries		estimated maximum up to 72 hrs
Secondary	% of instrumented vaginal deliveries		estimated maximum up to 72 hrs
Secondary	% of Caesarean sections		estimated maximum up to 72 hrs
Secondary	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)
Secondary	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.
Secondary	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.