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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 .
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dilapan-S | Device | Synthetic osmotic dilators Dilapan-S, Dilasoft for cervical ripening prior to induction of labor in women with unfavourable cervix |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Dilapan-S/Dilasoft insertion | duration of cervical ripening | max. up to 24 hrs; estimated average 12 hrs) |
| Induction - delivery interval | Overall duration of induced labor procedure | 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 | up to 24 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Type of osmotic dilator used: Dilapan-S or Dilasoft | up to 24 hrs; estimated average 12 hrs | |
| Number of dilators inserted | up to 24 hrs; estimated average 12 hrs | |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Lars Hellmeyer, Doz, MD | Vivantes Klinikum im Friedrichshain, Berlin, Germany | Principal Investigator |
| Franz Bahlman, Doz, MD | Buerger Hospital, Frankfurt am Main, Germany | Principal Investigator |
| Janesh Gupta, MD, FRCOG | Birmingham Women´s Hospital, Birmingham, UK | Study Chair |
| Petr Janku, MD | Masaryk University Hospital, Brno, Czech Republic | Principal Investigator |
| Jozef Zahumensky, Doc, MD | University Hospital, Trnava, Slovakia | Principal Investigator |
| Oleg Baev, MD, PhD | Federal State Budget Institution "Research Center for Obstetrics, Gynecology and Perinatology" of the Ministry of Healthcare of Russian Federation, Moscow, RUS | Principal Investigator |
| Antonio Saad, MD, PhD | University of Texas Medical Branch Galveston, TX, US | Principal Investigator |
| Amitasrigowri Murthy, MD, PhD | Bellevue Hospital, New York City, NY, US | Principal Investigator |
| Amita Suneja, Prof, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellevue Hospital | New York | New York | 10016 | United States | ||
| University of Texas Medical Branch Galveston |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15899354 | Background | Sanchez-Ramos L. Induction of labor. Obstet Gynecol Clin North Am. 2005 Jun;32(2):181-200, viii. doi: 10.1016/j.ogc.2004.12.004. | |
| 12776961 | Background | Tenore JL. Methods for cervical ripening and induction of labor. Am Fam Physician. 2003 May 15;67(10):2123-8. |
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| Bishop Score increase after extraction of osmotic dilators |
| up to 24 hrs; estimated average 12 hrs |
| Complications during pre-induction | uterine contractions, uterine hypersensitivity, effect on the foetus | up to 24 hrs; estimated average 12 hrs |
| Agents / procedures used for induction of labour, if any | which, total dosage | estimated maximum up to 72 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 |
| % of instrumented vaginal deliveries | estimated maximum up to 72 hrs |
| % of Caesarean sections | 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 | 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:
| 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:
| up to 72 hrs; Complications, if any, will be followed-up until stable situation has been reached. |
| Guru Teg Bahadur Hospital, New Delhi, India |
| Principal Investigator |
| Usha Vishwanath, MD | Sri Ramachandra Medical Center, Chennai, India | Principal Investigator |
| Anisha Gala, MD | Fernandez Hospital, Hyderabad, India | Principal Investigator |
| Galveston |
| Texas |
| 77555 |
| United States |
| Masaryk University | Brno | 625 00 | Czechia |
| Vivantes Klinikum im Friedrichshain | Berlin | 10249 | Germany |
| Buerger Hospital | Frankfurt am Main | 60318 | Germany |
| Guru Teg Bahadur Hospital | New Delhi | National Capital Territory of Delhi | 110095 | India |
| Sri Ramachandra Medical Center | Chennai | Tamil Nadu | 600116 | India |
| Fernandez Hospital | Hyderabad | Telangana | 500001 | India |
| Federal State Budget Institution "Research Center for Obstetrics, Gynecology and Perinatology" of the Ministry of Healthcare of Russian Federation | Moscow | 117997 | Russia |
| University Hospital Trnava | Trnava | 917 75 | Slovakia |
| Birmingham Women´s Hospital | Birmingham | West Midlands | B15 2TG | United Kingdom |
| 23506128 | Background | 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. |
| 23564065 | Background | 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. |
| 9914578 | Background | 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. doi: 10.1016/s0002-9378(99)70149-3. |
| 22704766 | Background | 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. |
| 24096438 | Background | 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. |
| 15199271 | Background | Lichtenberg ES. Complications of osmotic dilators. Obstet Gynecol Surv. 2004 Jul;59(7):528-36. doi: 10.1097/00006254-200407000-00022. |
| 9158305 | Background | 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. |
| 30107363 | Derived | Gupta J, Chodankar R, Baev O, Bahlmann F, Brega E, Gala A, Hellmeyer L, Hruban L, Maier J, Mehta P, Murthy A, Ritter M, Saad A, Shmakov R, Suneja A, Zahumensky J, Gdovinova D. Synthetic osmotic dilators in the induction of labour-An international multicentre observational study. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:70-75. doi: 10.1016/j.ejogrb.2018.08.004. Epub 2018 Aug 3. |