Abortion, SpontaneousPhase 4NCT00256009
Treatment of Late Abortion: Evacuatio Uteri or Conservative Treatment
A Phase 4 study testing Cytotec in people with Abortion, Spontaneous and Abortion, Induced, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
A randomize trial: expectation or evacuatio uteri for the treatment after late abortion Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Abortion, Spontaneous, Abortion, Induced
- What is being tested?
- Cytotec
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jan 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- abortion at gestational age (ultrasound) 14+0 - 20+0
Who cannot join
- Allergy to cytotec
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evacuatio Uteri or Conservtive Treatment After Late Abortion. A Randomize Trial.
A randomize trial: expectation or evacuatio uteri for the treatment after late abortion
Read the 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
- Conditions
- Abortion, Spontaneous, Abortion, Induced
- Being tested
- Cytotec
- Keywords
- Late abortion
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytotecDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Side-effect
Complication
Secondary outcomes (1)
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, SpontaneousStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Lars Alling Møller, MD phd, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256009
- Sponsor's protocol ID
- KF 01 279545
- Status last verified
- Nov 2005
- First submitted
- 18 Nov 2005
- Last updated
- 1 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evacuatio Uteri or Conservtive Treatment After Late Abortion. A Randomize Trial.
- ClinicalTrials.gov ID
- NCT00256009
- Acronym / sponsor ID
- KF 01 279545
- Conditions
- Abortion, Spontaneous, Abortion, Induced
- Keywords
- Late abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study completion
- Jan 2009
- First posted
- 21 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- abortion at gestational age (ultrasound) 14+0 - 20+0
Key exclusion criteria (1 listed)
- Allergy to cytotec
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytotec | Drug | – |
Primary outcome
Side-effect
Complication
1 secondary outcome
Quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Alling Møller, MD phd principal investigator
Copenhagen University Hospital, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cytotec in people with Abortion, Spontaneous and Abortion, Induced, run by Copenhagen University Hospital, Rigshospitalet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Alling Møller, Md phd (0045 35451338, Lars.Alling@rh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side-effect. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2006.