Dilapan-S / Dilasoft E-Registry in Induced Abortion

Abortion, Induced Clinical Trial

— DSREGISTRYIA  

Official title:

International Observational E-Registry on the Use of Dilapan-S/Dilasoft Osmotic Dilators for Cervical Priming Prior to Induced Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318212
• Other study ID #: DIS-2014-010
• Status: Completed
• Phase: N/A
• First received: December 9, 2014
• Last updated: May 18, 2017
• Start date: March 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 osmotic dilators DILAPAN-S® / DILASOFT® for cervical priming prior to induced abortion.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• 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:

• 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

Related Conditions & MeSH terms

• Abortion, Induced

Intervention

Device:
• Dilapan-S
Synthetic osmotic dilators Dilapan-S or Dilasoft for cervical priming prior to induced abortion

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

References & Publications (12)

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. Epub 2007 Jul 10. — View 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. — View 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. — View 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. Epub 2007 Nov 5. — View 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. — View Citation

Lichtenberg ES. Complications of osmotic dilators. Obstet Gynecol Surv. 2004 Jul;59(7):528-36. Review. — View 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. — View 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. — View 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):271-8. doi: 10.1097/AOG.0000000000000080. — View 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. Epub 2007 Feb 19. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of inserted osmotic dilators		max. up to 24 hrs; estimated average 6 hrs
Primary	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
Secondary	Type of synthetic osmotic dilator used	Dilapan-S or Dilasoft	max. up to 24 hrs; estimated average 6 hrs
Secondary	Complications during cervical priming	pre-operative bleeding, fever, pain, nausea, vomiting, diarrhoea, premature passage of foetal or chorionic tissue	up to 24 hrs; estimated average 6 hrs
Secondary	Other observed undesirable effects uf use of synthetic osmotic dilators		up to 24 hrs; estimated average 6 hrs
Secondary	Need of additional mechanical dilation	In cases, when surgical abortion is performed	up to 10 minutes after osmotic dilators extraction
Secondary	Surgical operative time	Period from speculum insertion in to speculum extraction out	estimated max. up to 10 min, estimated average 8 min.
Secondary	Initiation-to-delivery time	In case of medical abortion	hrs
Secondary	Induction-to-delivery time	In case of medical abortion	up to 72 hrs; estimated average 48 hrs
Secondary	Complications related to induced abortion procedure		up to 24 hrs; estimated average 12 hrs
Secondary	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.