PreeclampsiaNCT00260520
LMWH to Prevent Preeclampsia and Fetal Growth Restriction
An observational study of Preeclampsia, run by University of Florence.
Trial summary
The objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Dalteparin
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2002to Dec 2003
- Phase
- Observational
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Previous severe preeclampsia
- Previous severe fetal growth restriction
- Heterozygous Factor V Leiden
- Heterozygous G20210A prothrombin gene mutations
Who cannot join
- renal disease
- chronic hypertension
- preexisting diabetes mellitus
- homozygosity for Factor V Leiden
- homozygosity for prothrombin G20210A mutation
- hyperhomocysteinemia
Show all 11Show fewer
- protein C deficency
- protein S deficency
- antithrombin deficiency
- positive anticardiolipin antibodies
- positive lupus anticoagulant
About this study
Official title: Low Molecular Weight Heparin Vs No Treatment in Pregnant Women With Previous Preeclampsia or Fetal Growth Restriction Who Were Heterozygote for Factor V Leiden or Prothrombin Gene G20210A Mutation
The objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both.
Read the detailed description
The objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both. We also will assess the effect of treatment on other indicators of maternal and neonatal complications, and the growth of fetal body composition in terms of fat and lean body mass.
- Conditions
- Preeclampsia
- Being tested
- Dalteparin
- Keywords
- Low molecular weight heparin, Preeclampsia, Fetal Growth Restriction, Thrombophilia, Factor V Leiden, G20210A prothrombin gene mutation
- Medical subject headings
- Pre-Eclampsia, Fetal Growth Retardation, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalteparinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startJan 2002
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- 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
- Observational
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Investigators
- Giorgio Mello, MD, Study director, Department of Gynecology, Perinatology and Human Reproduction, University of Florence, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260520
- Sponsor's protocol ID
- 06-03-1942
- Status last verified
- Dec 2003
- First submitted
- 30 Nov 2005
- Last updated
- 6 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Molecular Weight Heparin Vs No Treatment in Pregnant Women With Previous Preeclampsia or Fetal Growth Restriction Who Were Heterozygote for Factor V Leiden or Prothrombin Gene G20210A Mutation
- ClinicalTrials.gov ID
- NCT00260520
- Acronym / sponsor ID
- 06-03-1942
- Conditions
- Preeclampsia
- Keywords
- Low molecular weight heparin, Preeclampsia, Fetal Growth Restriction, Thrombophilia, Factor V Leiden, G20210A prothrombin gene mutation
- Study type
- Observational
- Recruitment status
- Terminated
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- Dec 2003
- First posted
- 1 Dec 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.
The objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both.
Detailed description
The objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both. We also will assess the effect of treatment on other indicators of maternal and neonatal complications, and the growth of fetal body composition in terms of fat and lean body mass.
Study design
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Previous severe preeclampsia
- Previous severe fetal growth restriction
- Heterozygous Factor V Leiden
- Heterozygous G20210A prothrombin gene mutations
Key exclusion criteria (11 listed)
- renal disease
- chronic hypertension
- preexisting diabetes mellitus
- homozygosity for Factor V Leiden
- homozygosity for prothrombin G20210A mutation
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 |
|---|---|---|
| Dalteparin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2006.
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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Severe Preeclampsia
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.
Giorgio Mello, MD study director
Department of Gynecology, Perinatology and Human Reproduction, University of Florence, Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by University of Florence.
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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 6 Mar 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 6 Mar 2006.