Treatment of Late Abortion: Evacuatio Uteri or Conservative Treatment
Overview[ - collapse ][ - ]
| Purpose | A randomize trial: expectation or evacuatio uteri for the treatment after late abortion |
|---|---|
| Condition | Abortion, Spontaneous Abortion, Induced |
| Intervention | Drug: Cytotec |
| Phase | Phase 4 |
| Sponsor | Rigshospitalet, Denmark |
| Responsible Party | Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier | NCT00256009 |
| First Received | November 18, 2005 |
| Last Updated | May 31, 2006 |
| Last verified | November 2005 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 18, 2005 |
|---|---|
| Last Updated Date | May 31, 2006 |
| Start Date | Not Provided |
| Estimated Primary Completion Date | January 2009 |
| Current Primary Outcome Measures |
|
| Current Secondary Outcome Measures | Quality of life |
Descriptive Information[ + expand ][ + ]
| Brief Title | Treatment of Late Abortion: Evacuatio Uteri or Conservative Treatment |
|---|---|
| Official Title | 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 |
| 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 |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: Cytotec |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | 200 |
| Estimated Completion Date | January 2009 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: abortion at gestational age (ultrasound) 14+0 - 20+0 Exclusion Criteria: Allergy to cytotec |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Lars Alling Møller, Md phd 0045 35451338 Lars.Alling@rh.dk |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00256009 |
|---|---|
| Other Study ID Numbers | KF 01 279545 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Rigshospitalet, Denmark |
| Study Sponsor | Rigshospitalet, Denmark |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Lars Alling Møller, MD phd Rigshospitalet, Denmark |
| Verification Date | November 2005 |