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International Observational E-Registry on the use of osmotic dilators DILAPAN-S® / DILASOFT® for cervical priming prior to induced abortion.
International, multicentre, non-interventional, observational e-registry, post market clinical follow up study to document current clinical use of Dilapan-S or Dilasoft for cervical priming before induced abortion with regard to the number of dilators used, duration of insertion of dilators in situ and unusual complications consequent of their use.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dilapan-S | Device | Synthetic osmotic dilators Dilapan-S or Dilasoft for cervical priming prior to induced abortion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of inserted osmotic dilators | max. up to 24 hrs; estimated average 6 hrs | |
| Total time taken for cervical priming with Dilapan-S/Dilasoft | Duration of leaving osmotic dilators in situ | max. up to 24 hrs; estimated average 6 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Type of synthetic osmotic dilator used | Dilapan-S or Dilasoft | max. up to 24 hrs; estimated average 6 hrs |
| Complications during cervical priming | pre-operative bleeding, fever, pain, nausea, vomiting, diarrhoea, premature passage of foetal or chorionic tissue |
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Inclusion Criteria:
Exclusion Criteria:
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All patients indicated for cervical priming with Dilapan-S or Dilasoft prior to induced abortion and meet all inclusion and exclusion criteria in centres involved in data collection.
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Lohr, MD | British Pregnancy Advisory Service, UK | Principal Investigator |
| Jiri Hanacek, MD | Institute of Care for Mother and Child, Prague, CZ | Principal Investigator |
| Natalia Kan, Prof., MD | Research Center for Obstetrics, Gynecology and Perinatology, Moscow | Principal Investigator |
| John Roizin, MD | Allentown Women´s Center, Bethlehem, PA, US | Principal Investigator |
| Mary Jane Bovo, MD | Choices Women´s Medical Center, New York | Principal Investigator |
| LeRoy Carhart, MD | Germantown Reproductive Health Service | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17656184 | Background | Allen RH, Goldberg AB; Board of Society of Family Planning. Cervical dilation before first-trimester surgical abortion (<14 weeks' gestation). SFP Guideline 20071. Contraception. 2007 Aug;76(2):139-56. doi: 10.1016/j.contraception.2007.05.001. Epub 2007 Jul 10. | |
| 24331860 | Background | Fox MC, Krajewski CM. Cervical preparation for second-trimester surgical abortion prior to 20 weeks' gestation: SFP Guideline #2013-4. Contraception. 2014 Feb;89(2):75-84. doi: 10.1016/j.contraception.2013.11.001. Epub 2013 Nov 11. |
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| up to 24 hrs; estimated average 6 hrs |
| Other observed undesirable effects uf use of synthetic osmotic dilators | up to 24 hrs; estimated average 6 hrs |
| Need of additional mechanical dilation | In cases, when surgical abortion is performed | up to 10 minutes after osmotic dilators extraction |
| Surgical operative time | Period from speculum insertion in to speculum extraction out | estimated max. up to 10 min, estimated average 8 min. |
| Initiation-to-delivery time | In case of medical abortion | hrs |
| Induction-to-delivery time | In case of medical abortion | up to 72 hrs; estimated average 48 hrs |
| Complications related to induced abortion procedure | up to 24 hrs; estimated average 12 hrs |
| 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. |
| 18342657 | Background | Newmann S, Dalve-Endres A, Drey EA; Society of Family Planning. Clinical guidelines. Cervical preparation for surgical abortion from 20 to 24 weeks' gestation. Contraception. 2008 Apr;77(4):308-14. doi: 10.1016/j.contraception.2008.01.004. Epub 2008 Mar 4. |
| 6133988 | Background | Schulz KF, Grimes DA, Cates W Jr. Measures to prevent cervical injury during suction curettage abortion. Lancet. 1983 May 28;1(8335):1182-5. doi: 10.1016/s0140-6736(83)92464-9. |
| 15199271 | Background | Lichtenberg ES. Complications of osmotic dilators. Obstet Gynecol Surv. 2004 Jul;59(7):528-36. doi: 10.1097/00006254-200407000-00022. |
| 19126319 | Background | Samuel MI, Parsons JH. Hygroscopic dilator (Dilapan-S) and misoprostol combination for the early first-trimester termination of pregnancy: a pilot study. J Fam Plann Reprod Health Care. 2009 Jan;35(1):45-7. doi: 10.1783/147118909787072234. |
| 22114527 | Background | Chambers DG, Willcourt RJ, Laver AR, Baird JK, Herbert WY. Comparison of Dilapan-S and laminaria for cervical priming before surgical pregnancy termination at 17-22 weeks' gestation. Int J Womens Health. 2011;3:347-52. doi: 10.2147/IJWH.S25551. Epub 2011 Oct 20. |
| 17980952 | Background | Chen FC, Bergann A, Krosse J, Merholz A, David M. Isosorbide mononitrate vaginal gel versus misoprostol vaginal gel versus Dilapan-S for cervical ripening before first trimester curettage. Eur J Obstet Gynecol Reprod Biol. 2008 Jun;138(2):176-9. doi: 10.1016/j.ejogrb.2007.09.009. Epub 2007 Nov 5. |
| 23743471 | Background | Bartz D, Maurer R, Allen RH, Fortin J, Kuang B, Goldberg AB. Buccal misoprostol compared with synthetic osmotic cervical dilator before surgical abortion: a randomized controlled trial. Obstet Gynecol. 2013 Jul;122(1):57-63. doi: 10.1097/AOG.0b013e3182983889. |
| 22898362 | Background | Lyus R, Lohr PA, Taylor J, Morroni C. Outcomes with same-day cervical preparation with Dilapan-S osmotic dilators and vaginal misoprostol before dilatation and evacuation at 18 to 21+6 weeks' gestation. Contraception. 2013 Jan;87(1):71-5. doi: 10.1016/j.contraception.2012.07.006. Epub 2012 Aug 13. |
| 17309543 | Background | Poon LC, Parsons J. Audit of the effectiveness of cervical preparation with Dilapan prior to late second-trimester (20-24 weeks) surgical termination of pregnancy. BJOG. 2007 Apr;114(4):485-8. doi: 10.1111/j.1471-0528.2006.01257.x. Epub 2007 Feb 19. |
| 24402587 | Background | Newmann SJ, Sokoloff A, Tharyil M, Illangasekare T, Steinauer JE, Drey EA. Same-day synthetic osmotic dilators compared with overnight laminaria before abortion at 14-18 weeks of gestation: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):271-278. doi: 10.1097/AOG.0000000000000080. |