Treatment of Late Abortion: Evacuatio Uteri or Conservative Treatment
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Rigshospitalet, Denmark.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Rigshospitalet, Denmark
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00256009
First received: November 18, 2005
Last updated: May 31, 2006
Last verified: November 2005
| Tracking Information | |||||
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| First Received Date ICMJE | November 18, 2005 | ||||
| Last Updated Date | May 31, 2006 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00256009 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Quality of life | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment of Late Abortion: Evacuatio Uteri or Conservative Treatment | ||||
| Official Title ICMJE | Evacuatio Uteri or Conservtive Treatment After Late Abortion. A Randomize Trial. | ||||
| Brief Summary | A randomize trial: expectation or evacuatio uteri for the treatment after late abortion |
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| Detailed Description | A randomize trial adressing 200 women consecutively recruited from clinical practice at Rigshospitalet.Expectation: administration of 800 microgram Cytotec half an hour after delivery. Surgery: Evacuation of the uterus |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Cytotec | ||||
| Study Arm (s) | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Enrollment ICMJE | 200 | ||||
| Completion Date | January 2009 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: abortion at gestational age (ultrasound) 14+0 - 20+0 Exclusion Criteria: Allergy to cytotec |
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| Gender | Female | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00256009 | ||||
| Other Study ID Numbers ICMJE | KF 01 279545 | ||||
| Has Data Monitoring Committee | |||||
| Responsible Party | |||||
| Study Sponsor ICMJE | Rigshospitalet, Denmark | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Rigshospitalet, Denmark | ||||
| Verification Date | November 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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