Dilapan-S / Dilasoft E-Registry in Induced Abortion

NCT02318212 | Completed

• 1 other identifier: DIS-2014-010
• Study Type: observational
• Target: 439
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Abortion, Induced

Keywords

Cervical dilatation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (9)

• Type of synthetic osmotic dilator used

  max. up to 24 hrs; estimated average 6 hrs

• Complications during cervical priming

  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

  up to 10 minutes after osmotic dilators extraction

• Surgical operative time

  estimated max. up to 10 min, estimated average 8 min.

Interventions

Dilapan-S DEVICE

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

Also known as: Dilasoft

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Medicem International CR s.r.o.: lead

Related 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. doi: 10.1016/j.contraception.2007.05.001. Epub 2007 Jul 10.

  PMID: 17656184 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.

  PMID: 24331860 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.

  PMID: 18342657 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.

  PMID: 6133988 BACKGROUND

• Lichtenberg ES. Complications of osmotic dilators. Obstet Gynecol Surv. 2004 Jul;59(7):528-36. doi: 10.1097/00006254-200407000-00022.

  PMID: 15199271 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.

  PMID: 19126319 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.

  PMID: 22114527 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.

  PMID: 17980952 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.

  PMID: 23743471 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.

  PMID: 22898362 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.

  PMID: 17309543 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.

  PMID: 24402587 BACKGROUND

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 17, 2014
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 19, 2017

Record last verified: 2017-05