Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
439 participants
OBSERVATIONAL
2015-03-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Dilapan-S
Synthetic osmotic dilators Dilapan-S or Dilasoft for cervical priming prior to induced abortion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Acute bleeding
FEMALE
No
Sponsors
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Medicem International CR s.r.o.
INDUSTRY
Responsible Party
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Principal Investigators
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Patricia Lohr, MD
Role: PRINCIPAL_INVESTIGATOR
British Pregnancy Advisory Service, UK
Jiri Hanacek, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Care for Mother and Child, Prague, CZ
Natalia Kan, Prof., MD
Role: PRINCIPAL_INVESTIGATOR
Research Center for Obstetrics, Gynecology and Perinatology, Moscow
John Roizin, MD
Role: PRINCIPAL_INVESTIGATOR
Allentown Women´s Center, Bethlehem, PA, US
Mary Jane Bovo, MD
Role: PRINCIPAL_INVESTIGATOR
Choices Women´s Medical Center, New York
LeRoy Carhart, MD
Role: PRINCIPAL_INVESTIGATOR
Germantown Reproductive Health Service
References
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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.
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.
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.
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.
Lichtenberg ES. Complications of osmotic dilators. Obstet Gynecol Surv. 2004 Jul;59(7):528-36. doi: 10.1097/00006254-200407000-00022.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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DIS-2014-010
Identifier Type: -
Identifier Source: org_study_id
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