Clinical trial NCT02318212: Dilapan-S / Dilasoft E-Registry in Induced Abortion
Official title: International Observational E-Registry on the Use of Dilapan-S/Dilasoft Osmotic Dilators for Cervical Priming Prior to Induced Abortion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abortion, Induced
Keywords: Cervical dilatation
Lead sponsor: Medicem International CR s.r.o.
Sponsor class: INDUSTRY
First posted: 2014-12-17
Enrollment: 439
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 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.

Brief summary: International Observational E-Registry on the use of osmotic dilators DILAPAN-S® / DILASOFT® for cervical priming prior to induced abortion.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Intrauterine pregnancy ≥ 6 and ≤ 24 weeks gestation
* Patients who are capable of giving consent and sign the form
* Abortion being made in compliance with the Abortion Act 1967 (For England, Wales and Scotland)

Exclusion Criteria:

* Clinical signs of uterine, vaginal or vulvar infection
* Acute bleeding

Primary outcomes:
measure: Number of inserted osmotic dilators
timeFrame: max. up to 24 hrs; estimated average 6 hrs
measure: Total time taken for cervical priming with Dilapan-S/Dilasoft
timeFrame: max. up to 24 hrs; estimated average 6 hrs
Secondary outcomes:
measure: Type of synthetic osmotic dilator used
timeFrame: max. up to 24 hrs; estimated average 6 hrs
measure: Complications during cervical priming
timeFrame: up to 24 hrs; estimated average 6 hrs
measure: Other observed undesirable effects uf use of synthetic osmotic dilators
timeFrame: up to 24 hrs; estimated average 6 hrs
measure: Need of additional mechanical dilation
timeFrame: up to 10 minutes after osmotic dilators extraction
measure: Surgical operative time
timeFrame: estimated max. up to 10 min, estimated average 8 min.
measure: Initiation-to-delivery time
timeFrame: hrs
measure: Induction-to-delivery time
timeFrame: up to 72 hrs; estimated average 48 hrs
measure: Complications related to induced abortion procedure
timeFrame: up to 24 hrs; estimated average 12 hrs
measure: 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:
Study officials:
affiliation: British Pregnancy Advisory Service, UK
name: Patricia Lohr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Care for Mother and Child, Prague, CZ
name: Jiri Hanacek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Center for Obstetrics, Gynecology and Perinatology, Moscow
name: Natalia Kan, Prof., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Allentown Women´s Center, Bethlehem, PA, US
name: John Roizin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Choices Women´s Medical Center, New York
name: Mary Jane Bovo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Germantown Reproductive Health Service
name: LeRoy Carhart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Lichtenberg ES. Complications of osmotic dilators. Obstet Gynecol Surv. 2004 Jul;59(7):528-36. doi: 10.1097/00006254-200407000-00022.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.