Patients With Spontaneous Rupture of the Fetal MembranesNCT01903759
Kinetics of Inflammation Markers in Maternal Plasma: Study of the Correlation With the Diagnosis of Chorioamnionitis in Women Hospitalized for Spontaneous Rupture of the Fetal Membranes
A study testing Blood samples in people with Patients With Spontaneous Rupture of the Fetal Membranes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The principal aim of this study is to help obstetricians to diagnose chorioamniotic infection early, in cases of premature rupture of the fetal membranes before 34 WA, by proposing earlier and more specific markers of infection than FBC and CRP. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Patients With Spontaneous Rupture of the Fetal Membranes
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to May 2010
- Phase
- Interventional
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Term between 24 and 34 WA
- Spontaneous rupture of the fetal membranes
- Singleton pregnancy
- Age > 18 years
Who cannot join
- Delivery within the hour following admission
- Hospitalisation before 24 WA or after 34 WA
- Hemorrhagic placenta previa or retroplacental hematoma, known auto-immune or inflammatory disease
- Infection with human immunodeficiency virus (HIV)
- Refusal to provide consent.
- Patients provided for in articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g.: minors, adults under guardianship, etc…)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinetics of Inflammation Markers in Maternal Plasma (Interleukins, Matrix Metalloproteinases -MMP): Study of the Correlation With the Diagnosis of Chorioamnionitis in Women Hospitalized for Spontaneous Rupture of the Fetal Membranes (SPROM) Before 34 Weeks of Amenorrhea (WA) With no Modification in the Usual Therapy.
The principal aim of this study is to help obstetricians to diagnose chorioamniotic infection early, in cases of premature rupture of the fetal membranes before 34 WA, by proposing earlier and more specific markers of infection than FBC and CRP. The aim is to reduce vital and functional risk of acute chorioamnionitis for the mother, the fetus or the newborn,.
If the kinetics profile of one or several markers correlates strongly with the diagnosis of chorioamnionitis, it could be used in clinical practice, possibly in the context of another clinical study.
The results of the study presented here are destined to be published in obstetrics journals.
- Being tested
- Blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with spontaneous rupture of the fetal membranes | Other | Not described Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
determination of plasma cytokines
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startSep 2007
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Spontaneous Rupture of the Fetal MembranesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903759
- Sponsor's protocol ID
- Sagot PHRC IR 2006
- Status last verified
- Jul 2013
- First submitted
- 17 Jul 2013
- Last updated
- 19 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of Inflammation Markers in Maternal Plasma (Interleukins, Matrix Metalloproteinases -MMP): Study of the Correlation With the Diagnosis of Chorioamnionitis in Women Hospitalized for Spontaneous Rupture of the Fetal Membranes (SPROM) Before 34 Weeks of Amenorrhea (WA) With no Modification in the Usual Therapy.
- ClinicalTrials.gov ID
- NCT01903759
- Acronym / sponsor ID
- Sagot PHRC IR 2006
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Jul 2013 (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 principal aim of this study is to help obstetricians to diagnose chorioamniotic infection early, in cases of premature rupture of the fetal membranes before 34 WA, by proposing earlier and more specific markers of infection than FBC and CRP. The aim is to reduce vital and functional risk of acute chorioamnionitis for the mother, the fetus or the newborn,.
If the kinetics profile of one or several markers correlates strongly with the diagnosis of chorioamnionitis, it could be used in clinical practice, possibly in the context of another clinical study.
The results of the study presented here are destined to be published in obstetrics journals.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with spontaneous rupture of the fetal membranes | Other | Other: Blood samples |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Term between 24 and 34 WA
- Spontaneous rupture of the fetal membranes
- Singleton pregnancy
- Age > 18 years
Key exclusion criteria (6 listed)
- Delivery within the hour following admission
- Hospitalisation before 24 WA or after 34 WA
- Hemorrhagic placenta previa or retroplacental hematoma, known auto-immune or inflammatory disease
- Infection with human immunodeficiency virus (HIV)
- Refusal to provide consent.
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 samples | Other | Patients with spontaneous rupture of the fetal membranes |
Primary outcome
determination of plasma cytokines
Time frame: baseline
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 19 Jul 2013.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Patients With Spontaneous Rupture of the Fetal Membranes, run by Centre Hospitalier Universitaire Dijon at 1 site 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 4 inclusion and 6 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 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
What does the primary outcome measure?
determination of plasma cytokines (time frame: baseline). 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 19 Jul 2013.