Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-03-17 @ 8:29 PM
Study NCT ID:
NCT02318212
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2014-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dilapan-S / Dilasoft E-Registry in Induced Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 439}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-18', 'studyFirstSubmitDate': '2014-12-09', 'studyFirstSubmitQcDate': '2014-12-11', 'lastUpdatePostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'Duration of leaving osmotic dilators in situ'}], 'secondaryOutcomes': [{'measure': 'Type of synthetic osmotic dilator used', 'timeFrame': 'max. up to 24 hrs; estimated average 6 hrs', 'description': 'Dilapan-S or Dilasoft'}, {'measure': 'Complications during cervical priming', 'timeFrame': 'up to 24 hrs; estimated average 6 hrs', 'description': 'pre-operative bleeding, fever, pain, nausea, vomiting, diarrhoea, premature passage of foetal or chorionic tissue'}, {'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', 'description': 'In cases, when surgical abortion is performed'}, {'measure': 'Surgical operative time', 'timeFrame': 'estimated max. up to 10 min, estimated average 8 min.', 'description': 'Period from speculum insertion in to speculum extraction out'}, {'measure': 'Initiation-to-delivery time', 'timeFrame': 'hrs', 'description': 'In case of medical abortion'}, {'measure': 'Induction-to-delivery time', 'timeFrame': 'up to 72 hrs; estimated average 48 hrs', 'description': 'In case of medical abortion'}, {'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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cervical dilatation'], 'conditions': ['Abortion, Induced']}, 'referencesModule': {'references': [{'pmid': '17656184', 'type': 'BACKGROUND', '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."}, {'pmid': '24331860', 'type': 'BACKGROUND', '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."}, {'pmid': '18342657', 'type': 'BACKGROUND', '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."}, {'pmid': '6133988', 'type': 'BACKGROUND', '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.'}, {'pmid': '15199271', 'type': 'BACKGROUND', 'citation': 'Lichtenberg ES. Complications of osmotic dilators. Obstet Gynecol Surv. 2004 Jul;59(7):528-36. doi: 10.1097/00006254-200407000-00022.'}, {'pmid': '19126319', 'type': 'BACKGROUND', '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.'}, {'pmid': '22114527', 'type': 'BACKGROUND', '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."}, {'pmid': '17980952', 'type': 'BACKGROUND', '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.'}, {'pmid': '23743471', 'type': 'BACKGROUND', '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.'}, {'pmid': '22898362', 'type': 'BACKGROUND', '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."}, {'pmid': '17309543', 'type': 'BACKGROUND', '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.'}, {'pmid': '24402587', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'International Observational E-Registry on the use of osmotic dilators DILAPAN-S® / DILASOFT® for cervical priming prior to induced abortion.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intrauterine pregnancy ≥ 6 and ≤ 24 weeks gestation\n* Patients who are capable of giving consent and sign the form\n* Abortion being made in compliance with the Abortion Act 1967 (For England, Wales and Scotland)\n\nExclusion Criteria:\n\n* Clinical signs of uterine, vaginal or vulvar infection\n* Acute bleeding'}, 'identificationModule': {'nctId': 'NCT02318212', 'acronym': 'DSREGISTRYIA', 'briefTitle': 'Dilapan-S / Dilasoft E-Registry in Induced Abortion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medicem International CR s.r.o.'}, 'officialTitle': 'International Observational E-Registry on the Use of Dilapan-S/Dilasoft Osmotic Dilators for Cervical Priming Prior to Induced Abortion', 'orgStudyIdInfo': {'id': 'DIS-2014-010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dilapan-S', 'type': 'DEVICE', 'otherNames': ['Dilasoft'], 'description': 'Synthetic osmotic dilators Dilapan-S or Dilasoft for cervical priming prior to induced abortion'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Patricia Lohr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'British Pregnancy Advisory Service, UK'}, {'name': 'Jiri Hanacek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Care for Mother and Child, Prague, CZ'}, {'name': 'Natalia Kan, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Center for Obstetrics, Gynecology and Perinatology, Moscow'}, {'name': 'John Roizin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Allentown Women´s Center, Bethlehem, PA, US'}, {'name': 'Mary Jane Bovo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Choices Women´s Medical Center, New York'}, {'name': 'LeRoy Carhart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Germantown Reproductive Health Service'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medicem International CR s.r.o.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}