Fetal LossesNCT01690858
Multicentric Prospective Study of Genetic and Physiopathology Concerning Dysregulation of Complement During Repeated Fetal Abortions
An observational study of Fetal Losses, run by Nantes University Hospital at 2 sites in France.
Trial summary
The aim of the study is to assess the role of complement dysregulation and its impact on antiangiogenic factors (soluble Flt1 and endoglin) in patients with foetal losses. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Losses
- What is being tested?
- blood sample
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- May 2011to May 2013
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Females with medical history of repeated foetal losses and females without medical history of repeated foetal losses as controls.
Who may be able to join
- Inclusion criteria for females with repeated fetal losses:
- Age> 18
- Female affiliated to French health insurance (Social Security),
- Informed consent form signed
- Patient with history of at least three foetal losses without any cause found (chromosomal abnormalities, uterine malformations, endocrine disorders, etc.)
Who cannot join
- Patient not fulfilling inclusion criteria
- Age > 40
- Female unable to understand benefits and risks of protocol
- Female with history of repeated foetal losses of infectious or endocrine origin.
- Inclusion criteria for females without repeated fetal losses:
- Age> 18
Show all 13Show fewer
- Female affiliated to the French health insurance (Social Security)
- Informed consent form signed
- Female without history of repeated foetal losses
- Exclusion criteria for females without repeated fetal losses:
- Patient not fulfilling inclusion criteria
- Female with age above 40
- Female unable to understand benefits and risks of protocol
Trial locations and contacts
2 sites in 1 country.
France2 sites
Antoine Beclere Hospital (AP-HP)
Clamart, 92141
CHU
Nantes, France, 44093
About this study
The aim of the study is to assess the role of complement dysregulation and its impact on antiangiogenic factors (soluble Flt1 and endoglin) in patients with foetal losses.
Read the detailed description
Females with medical history of repeated foetal losses will have blood sampling to perform analyses. If pregnant, blood sampling will be performed at different times throughout the pregnancy.
Controls will be females without medical history of repeated foetal losses. They will also have blood sampling to perform analyses. If pregnant, blood sampling will be performed at different times throughout the pregnancy.
Blood analyses will focus on :
- mutations in genes coding for molecules that modulate complement activity
- serum levels of sFlt1 and endoglin and their link to complement activation
- Conditions
- Fetal Losses
- Being tested
- blood sample
- Keywords
- Foetal loss, complement, antiangiogenic factors, Repeated fetal losses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
blood sampling at inclusion and throughout pregnancy when pregnant
| Study group | Role | What they receive |
|---|---|---|
| females with medical history of repeated foetal losses | The females can be pregnant Receives: Other: blood sample | |
| females without medical history of repeated foetal losses | The females can be pregnant Receives: Other: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
mutations in genes coding for molecules that modulate complement activity
to determine frequency of mutations of genes (membrane-cofactor protein (MCP), decay accelerating factor (DAF), ....) involved in complement activation : Profiles of these genes will be analysed in blood sample of females with medical history of repeated foetal losses and compared to those analysed in blood sample of females without medical history of repeated foetal losses.
Measured: day1 (at inclusion)
Secondary outcomes (4)
serum levels of sFlt1 and endoglin and their link to complement activation markers
To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.
Measured: 4 weeks post pregnancy start
serum levels of sFlt1 and endoglin and their link to complement activation
To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.
Measured: 8 weeks post pregnancy start
serum levels of sFlt1 and endoglin and their link to complement activation
To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.
Measured: 16 weeks post pregnancy start
serum levels of sFlt1 and endoglin and their link to complement activation
To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.
Measured: 24 weeks post pregnancy start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startMay 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal LossesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690858
- Sponsor's protocol ID
- 10/6-K
- Status last verified
- Oct 2014
- First submitted
- 29 Nov 2011
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Prospective Study of Genetic and Physiopathology Concerning Dysregulation of Complement During Repeated Fetal Abortions
- ClinicalTrials.gov ID
- NCT01690858
- Acronym / sponsor ID
- 10/6-K
- Conditions
- Fetal Losses
- Keywords
- Foetal loss, complement, antiangiogenic factors, Repeated fetal losses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Sep 2012 (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 aim of the study is to assess the role of complement dysregulation and its impact on antiangiogenic factors (soluble Flt1 and endoglin) in patients with foetal losses.
Detailed description
Females with medical history of repeated foetal losses will have blood sampling to perform analyses. If pregnant, blood sampling will be performed at different times throughout the pregnancy.
Controls will be females without medical history of repeated foetal losses. They will also have blood sampling to perform analyses. If pregnant, blood sampling will be performed at different times throughout the pregnancy.
Blood analyses will focus on :
- mutations in genes coding for molecules that modulate complement activity
- serum levels of sFlt1 and endoglin and their link to complement activation
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| females with medical history of repeated foetal losses | – | Other: blood sampleThe females can be pregnant |
| females without medical history of repeated foetal losses | – | Other: blood sampleThe females can be pregnant |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Females with medical history of repeated foetal losses and females without medical history of repeated foetal losses as controls.
Key inclusion criteria (5 listed)
- Inclusion criteria for females with repeated fetal losses:
- Age> 18
- Female affiliated to French health insurance (Social Security),
- Informed consent form signed
- Patient with history of at least three foetal losses without any cause found (chromosomal abnormalities, uterine malformations, endocrine disorders, etc.)
Key exclusion criteria (13 listed)
- Patient not fulfilling inclusion criteria
- Age > 40
- Female unable to understand benefits and risks of protocol
- Female with history of repeated foetal losses of infectious or endocrine origin.
- Age> 18
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 |
|---|---|---|
| blood sampleblood sampling at inclusion and throughout pregnancy when pregnant | Other | females with medical history of repeated foetal losses, females without medical history of repeated foetal losses |
Primary outcome
mutations in genes coding for molecules that modulate complement activity
Time frame: day1 (at inclusion)
to determine frequency of mutations of genes (membrane-cofactor protein (MCP), decay accelerating factor (DAF), ....) involved in complement activation : Profiles of these genes will be analysed in blood sample of females with medical history of repeated foetal losses and compared to those analysed in blood sample of females without medical history of repeated foetal losses.
4 secondary outcomes
serum levels of sFlt1 and endoglin and their link to complement activation markers
Time frame: 4 weeks post pregnancy start
serum levels of sFlt1 and endoglin and their link to complement activation
Time frame: 8 weeks post pregnancy start
serum levels of sFlt1 and endoglin and their link to complement activation
Time frame: 16 weeks post pregnancy start
serum levels of sFlt1 and endoglin and their link to complement activation
Time frame: 24 weeks post pregnancy start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Losses, run by Nantes University Hospital at 2 sites in France.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
mutations in genes coding for molecules that modulate complement activity (time frame: day1 (at inclusion)). 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 15 Oct 2014.