Preterm Premature Rupture of MembranesMuMFI-PPROMNCT02702297
Multimodal Monitoring of Fetal Risk of Inflammation in Preterm Premature Rupture of Membranes
An observational study of Preterm Premature Rupture of Membranes and Fetal Inflammatory Response Syndrome, run by Martin-Luther-Universität Halle-Wittenberg at 4 sites in Germany.
Trial summary
The purpose of this study is to examine whether the value of vaginal fluid cytokine levels as well as computerized fetal ECG analysis are suitable clinical parameters to detect an imminent intra-amniotic inflammation with a high risk of fetal inflammatory response syndrome (FIRS) or a neonatal early onset sepsis (EOS)… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Premature Rupture of Membranes, Fetal Inflammatory Response Syndrome, Early Onset Neonatal Sepsis
- What is being tested?
- single arm
- How many people
- 57 participants
- Where
- 4 sitesGermany
- Study dates
- 7 Jan 2016to 10 Nov 2018
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with PPROM-complicated pregnancies who referre to one of the participating tertiary referreal care centers.
Who may be able to join
- Clinical diagnosis of preterm rupture of the fetal membranes
- Pregnancy between 24 0/7 and 34 0/7 weeks of gestation
- Ability to give informed consent in german or english
Who cannot join
- Sign of acute amniotic infection syndrome
- independent indication for urgent delivery
- Active labor
- Missing informed consent
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
St. Elisabeth Hospital Halle
Halle, Saxony-Anhalt, 06110
Maternity Clinic/Perinatal Treatment Center, university hospital, Martin-Luther-Universität Halle-Wittenberg
Halle, Saxony-Anhalt, 06120
Maternity Clinic, Jena University Hospital
Jena, Thuringia, 07743
Maternity clinic, University of Leipzig
Leipzig, Saxony, 04103
About this study
Official title: Multimodales Monitoring Des Fetalen Inflammationsrisikos Bei frühem Vorzeitigen Blasensprung (PPROM)
The purpose of this study is to examine whether the value of vaginal fluid cytokine levels as well as computerized fetal ECG analysis are suitable clinical parameters to detect an imminent intra-amniotic inflammation with a high risk of fetal inflammatory response syndrome (FIRS) or a neonatal early onset sepsis (EOS) and whether these parameters can be determined on a daily basis in the clinical monitoring of pregnancies complicated by PPROM.
Read the detailed description
Preterm premature rupture of membranes (PPROM) is one of the leading causes for preterm birth and adverse neonatal outcome. Between 24 0/7 and 34 0/7 weeks of gestation the prolongation of pregnancy is the recommended course of action to reduce the risks of prematurity in most countries. An intra-amniotic infection resulting in fetal inflammatory response syndrome (FIRS) or early onset neonatal sepsis (EOS) is often associated with high morbidity and mortality.
Standard monitoring includes the maternal response to inflammation (i.e. maternal serum parameters) as well as fetal signs of acute FIRS (i.e. fetal tachycardia, high cytokine level in amniotic fluid obtained by amniocentesis). Changes of fetal ECG-parameters are also a sign of an acute FIRS.
Currently, there is no adequate parameter for the surveillance of a possible ongoing intra-amniotic infection. Other studies have reported a correlation between vaginal fluid interleukine 6 (IL6) collected noninvasively and the risk of FIRS and EOS. Information obtained by computerized fetal ECG analysis might be suitable to detect early signs of fetal infection before the manifestation of FIRS.
With the implementation of a vaginal fluid collector it is possible to detect the vaginal fluid cytokine in clinical everyday routine. With the improvement of fetal ECG monitoring it is possible to record the fetal ECG daily. This study examines the correlation between these new parameters and the onset of fetal infection before the manifestation of a severe systemic fetal inflammation.
- Conditions
- Preterm Premature Rupture of Membranes, Fetal Inflammatory Response Syndrome, Early Onset Neonatal Sepsis, Infection of Amniotic Cavity
- Being tested
- single arm
- Keywords
- Preterm premature rupture of the membranes, PPROM, PROM, fetal membranes, premature rupture, neonatal early onset sepsis, amniotic fluid, amniotic infection, fetal inflammatory response syndrome, adverse neonatal outcome, FIRS
- Medical subject headings
- Preterm Premature Rupture of the Membranes, fetal inflammatory response syndrome, Neonatal Sepsis, Chorioamnionitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single armOther
Daily monitoring of vaginal fluid IL6 and fetal ECG. Daily maternal monitoring and delivery according to standard operating procedure. Post partum diagnosis of FIRS or EOS by analysing of fetal cord blood IL6 and clinical signs of sepsis. Diagnosis of histologic amniotic infection by histological analysis.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | daily multimodal monitoring during pregnancy after PPROM, Analysis of neonatal routine parameters and histologic examination of placenta Receives: Other: single arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds ratio for severe fetal/early onset neonatal Infection
combined outcome - rate of: early onset neonatal sepsis, elevated IL6 concentration in cord blood sample, histological signs of funisitis
Measured: postpartum one point assessment/ first three days post partum
Secondary outcomes (7)
combined neonatal adverse outcome
rate of severe intraventricular hemorrhage, necrotizing enterocolitis, late onset sepsis, white matter damage within the first 28 days of life
Measured: 28 days
late onset neonatal sepsis
clinical Sepsis after first 72h of life
Measured: 28 days
Severe neonatal cerebral hemorrhage
IVH II+IV°
Measured: 28 days
necrotizing enterocolitis
NEC
Measured: 28 days
umbilical cord blood IL 6 concentration
IL-6-concentration in cord blood sample after delivery or in fetal Serum during first hour of life
Measured: first day after delivery
neonatal early onset sepsis
clinical Sepsis during first 72h of life
Measured: 3 days
histological funisitis
redline maternal stage >1, fetal stage >0
Measured: first day after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study start7 Jan 2016
- Primary completion28 Feb 2018
- Study completion10 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Premature Rupture of MembranesStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- Jena University Hospital, University of Leipzig, St. Elisabeth Hospital Halle
- Responsible party
- Principal investigator, Gregor Seliger, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Gregor Seliger, Dr. med, Principal investigator, Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-WittenbergMichael Bergner, Principal investigator, Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-WittenbergUwe Schneider, Prof., Principal investigator, Maternity Clinic; Jena University HospitalMichael Tchirikov, Prof., Study chair, Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-WittenbergFrank Bernhard Kraus, PD; PhD, Principal investigator, Department of Laboratory Medicine; Halle university hospital, Martin-Luther-Universität Halle-WittenbergRoland Haase, PD, Principal investigator, Department of Pediatrics; Halle university hospital, Martin-Luther-Universität Halle-WittenbergHolger Stepan, Prof., Principal investigator, Maternity clinic, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702297
- Sponsor's protocol ID
- MuMFI-PPROM
- Acronym
- MuMFI-PPROM
- Status last verified
- Nov 2018
- First submitted
- 22 Feb 2016
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodales Monitoring Des Fetalen Inflammationsrisikos Bei frühem Vorzeitigen Blasensprung (PPROM)
- ClinicalTrials.gov ID
- NCT02702297
- Acronym / sponsor ID
- MuMFI-PPROM / MuMFI-PPROM
- Conditions
- Preterm Premature Rupture of Membranes, Fetal Inflammatory Response Syndrome, Early Onset Neonatal Sepsis, Infection of Amniotic Cavity
- Keywords
- Preterm premature rupture of the membranes, PPROM, PROM, fetal membranes, premature rupture, neonatal early onset sepsis, amniotic fluid, amniotic infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- Jena University Hospital, University of Leipzig, St. Elisabeth Hospital Halle
- Study start
- 7 Jan 2016 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 10 Nov 2018 (actual)
- First posted
- 8 Mar 2016 (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 purpose of this study is to examine whether the value of vaginal fluid cytokine levels as well as computerized fetal ECG analysis are suitable clinical parameters to detect an imminent intra-amniotic inflammation with a high risk of fetal inflammatory response syndrome (FIRS) or a neonatal early onset sepsis (EOS) and whether these parameters can be determined on a daily basis in the clinical monitoring of pregnancies complicated by PPROM.
Detailed description
Preterm premature rupture of membranes (PPROM) is one of the leading causes for preterm birth and adverse neonatal outcome. Between 24 0/7 and 34 0/7 weeks of gestation the prolongation of pregnancy is the recommended course of action to reduce the risks of prematurity in most countries. An intra-amniotic infection resulting in fetal inflammatory response syndrome (FIRS) or early onset neonatal sepsis (EOS) is often associated with high morbidity and mortality.
Standard monitoring includes the maternal response to inflammation (i.e. maternal serum parameters) as well as fetal signs of acute FIRS (i.e. fetal tachycardia, high cytokine level in amniotic fluid obtained by amniocentesis). Changes of fetal ECG-parameters are also a sign of an acute FIRS.
Currently, there is no adequate parameter for the surveillance of a possible ongoing intra-amniotic infection. Other studies have reported a correlation between vaginal fluid interleukine 6 (IL6) collected noninvasively and the risk of FIRS and EOS. Information obtained by computerized fetal ECG analysis might be suitable to detect early signs of fetal infection before the manifestation of FIRS.
With the implementation of a vaginal fluid collector it is possible to detect the vaginal fluid cytokine in clinical everyday routine. With the improvement of fetal ECG monitoring it is possible to record the fetal ECG daily. This study examines the correlation between these new parameters and the onset of fetal infection before the manifestation of a severe systemic fetal inflammation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | – | Other: single armdaily multimodal monitoring during pregnancy after PPROM, Analysis of neonatal routine parameters and histologic examination of placenta |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with PPROM-complicated pregnancies who referre to one of the participating tertiary referreal care centers.
Key inclusion criteria (3 listed)
- Clinical diagnosis of preterm rupture of the fetal membranes
- Pregnancy between 24 0/7 and 34 0/7 weeks of gestation
- Ability to give informed consent in german or english
Key exclusion criteria (4 listed)
- Sign of acute amniotic infection syndrome
- independent indication for urgent delivery
- Active labor
- Missing informed 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 |
|---|---|---|
| single armDaily monitoring of vaginal fluid IL6 and fetal ECG. Daily maternal monitoring and delivery according to standard operating procedure. Post partum diagnosis of FIRS or EOS by analysing of fetal cord blood IL6 and clinical signs of sepsis. Diagnosis of histologic amniotic infection by histological analysis. | Other | Single arm |
Primary outcome
Odds ratio for severe fetal/early onset neonatal Infection
Time frame: postpartum one point assessment/ first three days post partum
combined outcome - rate of: early onset neonatal sepsis, elevated IL6 concentration in cord blood sample, histological signs of funisitis
7 secondary outcomes
combined neonatal adverse outcome
Time frame: 28 days
late onset neonatal sepsis
Time frame: 28 days
Severe neonatal cerebral hemorrhage
Time frame: 28 days
necrotizing enterocolitis
Time frame: 28 days
umbilical cord blood IL 6 concentration
Time frame: first day after delivery
neonatal early onset sepsis
Time frame: 3 days
histological funisitis
Time frame: first day after delivery
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 14 Nov 2018.
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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.
Gregor Seliger, Dr. med principal investigator
Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
Michael Bergner principal investigator
Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg
Uwe Schneider, Prof. principal investigator
Maternity Clinic; Jena University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Premature Rupture of Membranes and Fetal Inflammatory Response Syndrome, run by Martin-Luther-Universität Halle-Wittenberg at 4 sites in Germany.
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 3 inclusion and 4 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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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?
Odds ratio for severe fetal/early onset neonatal Infection (time frame: postpartum one point assessment/ first three days post partum). 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 14 Nov 2018.