Clinical trial NCT02318173: Dilapan-S/Dilasoft E-Registry in Induction of Labor
Official title: International Observational E-Registry on the Use of Dilapan-S / Dilasoft Osmotic Dilators for Cervical Ripening Prior to Labour Induction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labour Onset and Length Abnormalities
Labor; Forced or Induced, Affecting Fetus or Newborn
Keywords: Cervical dilatation
Lead sponsor: Medicem International CR s.r.o.
Sponsor class: INDUSTRY
First posted: 2014-12-17
Enrollment: 444
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the patients in whom the use of osmotic dilators Dilapan-S or Dilasoft is indicated by the Investigator after a thorough Medical examination will be included in the study unless that the patient disagree.

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 .

Eligibility criteria: Inclusion Criteria:

* Indication for induction of labor
* Unfavourable cervix

Exclusion Criteria:

* Presence of overt genital tract infection

Primary outcomes:
measure: Duration of Dilapan-S/Dilasoft insertion
timeFrame: max. up to 24 hrs; estimated average 12 hrs)
measure: Induction - delivery interval
timeFrame: estimated maximum up to 72 hrs
measure: Rate of vaginal deliveries within 24 hours
timeFrame: up to 24 hrs
Secondary outcomes:
measure: Type of osmotic dilator used: Dilapan-S or Dilasoft
timeFrame: up to 24 hrs; estimated average 12 hrs
measure: Number of dilators inserted
timeFrame: up to 24 hrs; estimated average 12 hrs
measure: Bishop Score increase after extraction of osmotic dilators
timeFrame: up to 24 hrs; estimated average 12 hrs
measure: Complications during pre-induction
timeFrame: up to 24 hrs; estimated average 12 hrs
measure: Agents / procedures used for induction of labour, if any
timeFrame: estimated maximum up to 72 hrs
measure: % of spontaneous vaginal deliveries following immediately after pre-induction
timeFrame: up to 24 hrs
measure: % of total spontaneous vaginal deliveries
timeFrame: estimated maximum up to 72 hrs
measure: % of instrumented vaginal deliveries
timeFrame: estimated maximum up to 72 hrs
measure: % of Caesarean sections
timeFrame: estimated maximum up to 72 hrs
measure: Foetal status
timeFrame: 0, 5 and 10 minutes after delivery (estimated maximum up to 72 hrs)
measure: Maternal infectious complication and its relation to the use of Dilapan-S/Dilasoft
timeFrame: up to 72 hrs; Complications, if any, will be followed-up until stable situation has been reached.
measure: Neonatal infectious complication and its relation to the use of Dilapan-S/Dilasoft
timeFrame: up to 72 hrs; Complications, if any, will be followed-up until stable situation has been reached.
Other outcomes:
Locations:
city: New York
country: United States
facility: Bellevue Hospital
state: New York
city: Galveston
country: United States
facility: University of Texas Medical Branch Galveston
state: Texas
city: Brno
country: Czechia
facility: Masaryk University
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshain
city: Frankfurt am Main
country: Germany
facility: Buerger Hospital
city: New Delhi
country: India
facility: Guru Teg Bahadur Hospital
state: Delhi
city: Chennai
country: India
facility: Sri Ramachandra Medical Center
state: Tamil Nadu
city: Hyderabad
country: India
facility: Fernandez Hospital
state: Telangana
city: Moscow
country: Russian Federation
facility: Federal State Budget Institution "Research Center for Obstetrics, Gynecology and Perinatology" of the Ministry of Healthcare of Russian Federation
city: Trnava
country: Slovakia
facility: University Hospital Trnava
city: Birmingham
country: United Kingdom
facility: Birmingham Women´s Hospital
state: West Midlands
Study officials:
affiliation: Vivantes Klinikum im Friedrichshain, Berlin, Germany
name: Lars Hellmeyer, Doz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Buerger Hospital, Frankfurt am Main, Germany
name: Franz Bahlman, Doz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Birmingham Women´s Hospital, Birmingham, UK
name: Janesh Gupta, MD, FRCOG
role: STUDY_CHAIR
affiliation: Masaryk University Hospital, Brno, Czech Republic
name: Petr Janku, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Trnava, Slovakia
name: Jozef Zahumensky, Doc, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal State Budget Institution "Research Center for Obstetrics, Gynecology and Perinatology" of the Ministry of Healthcare of Russian Federation, Moscow, RUS
name: Oleg Baev, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Medical Branch Galveston, TX, US
name: Antonio Saad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bellevue Hospital, New York City, NY, US
name: Amitasrigowri Murthy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guru Teg Bahadur Hospital, New Delhi, India
name: Amita Suneja, Prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sri Ramachandra Medical Center, Chennai, India
name: Usha Vishwanath, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fernandez Hospital, Hyderabad, India
name: Anisha Gala, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Tenore JL. Methods for cervical ripening and induction of labor. Am Fam Physician. 2003 May 15;67(10):2123-8.
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.
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citation: Lichtenberg ES. Complications of osmotic dilators. Obstet Gynecol Surv. 2004 Jul;59(7):528-36. doi: 10.1097/00006254-200407000-00022.
citation: 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. doi: 10.1111/j.1447-0756.1997.tb00828.x.
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