Premature Rupture of MembraneRECHOBIOLNCT04237142
Preterm Premature Rupture of Fetal Membranes: Cervical Ultrasound and Biological Markers to Diagnose Prematurity (RECHOBIOL)
A study testing Vaginal secretions collection and Blood sample in people with Premature Rupture of Membrane, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Our main hypothesis is to consider that the detection of biomarkers on admission combined with the length of the cervix would improve the prediction of the latency period in case of preterm premature rupture of membranes (pPROM). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Premature Rupture of Membrane
- What is being tested?
- Vaginal secretions collection and Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2020to Mar 2023
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Parturient admitted to the Clermont-Ferrand Hospital maternity for preterm premature rupture of membranes between 24+0 and 36+4 gestation week.
- Capacity to give informed consent.
- Coverage by a French social security scheme.
Who cannot join
- Refusal to participate
- pPROM formally occurred more than 24 hours ago (free flow or positive breakage test)
- Cervical dilatation ≥ 4 cm
- Multiple Pregnancy
- Known uterine malformation
- Fetal Malformation
Show all 9Show fewer
- Placenta previa
- Abundant metrorrhagia
- Patient under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Denis Gallot
About this study
Official title: Preterm Premature Rupture of Fetal Membranes: Cervical Ultrasound and Biological Markers to Diagnose Prematurity.
Our main hypothesis is to consider that the detection of biomarkers on admission combined with the length of the cervix would improve the prediction of the latency period in case of preterm premature rupture of membranes (pPROM). The primary purpose of the protocol is to assess the performance of these tests to predict a latency period <48 hours in case of pPROM.
Read the detailed description
Preterm premature rupture of membranes (pPROM) is defined as a spontaneous rupture before the start of labor ("premature" rupture) and before 37 weeks of gestation ("preterm"). pPROM concern 2-3% of pregnancies. It is the main cause of prematurity since it is responsible for 24 to 42% of preterm deliveries. The time between PROM and childbirth is named the latency period. Its total duration can vary from a few hours to several weeks. Childbirth occurs within 48 hours of rupture for 18 to 93% of cases, within 7 days for 56 to 96% and within 28 days for 78 to 100%. The earlier PROM occurs during pregnancy, the longer the latency period is. The factors associated with a shorter latency period are: cervical changes during admission for pPROM, a shortened cervix on ultrasound or a threat of premature delivery prior to PROM, the existence of uterine contractions, oligoamnios, and the occurrence of a materno-fetal complication of pPROM.
In a pPROM situation, a prolonged latency period improves the neonatal prognosis by increasing the gestational age of birth, gives the possibility of administering the corticosteroid treatment of fetal pulmonary maturation and also allows an in utero transfer in an adapted maternity.
Several studies have shown a correlation between the length of the cervix during rupture and the latency period in the context of pPROM.
To date, there are no effective biomarkers used in current practice to predict this latency period.
We want to assess the diagnostic performance of different vaginal (PIBF / PP14 / IGFBP1 native and total) and serum (PIBF / MIF) markers as well as the ultrasound length of the cervix to predict the duration of this latency period in order to better anticipate the risk of prematurity.
- Conditions
- Premature Rupture of Membrane
- Being tested
- Vaginal secretions collection, Blood sample
- Keywords
- Preterm premature rupture of membranes, Biomarkers, Latency period, Predictive Value of Tests
- Medical subject headings
- Fetal Membranes, Premature Rupture, Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal secretions collectionDiagnostic test
Vaginal secretions are collected under speculum with a swab (10 seconds of impregnation of the swab). The swab is immersed in a tube containing an extraction buffer for 10 seconds. The tube is mixed and sent to the laboratory for subsequent analysis of biomarkers (IGFBP1 T/N, PIBF, PP14) and storage.
Blood sampleDiagnostic test
2 tubes of blood sample were collected and sent to the laboratory for serum storage and biomarkeurs assay (PIBF and MIF)
| Study group | Role | What they receive |
|---|---|---|
| Eligible patients who had consented to participate | Experimental | Eligible patients who had consented to participate to the study, namely parturient admitted to the Clermont-Ferrand Hospital maternity for preterm premature rupture of membranes between 24+0 and 36+4 gestation week with cervical dilation < 4cm and without known uterine malformation, fetal malformation, placenta previa or abundant metrorrhagia. Patients underwent vaginal swabbing and blood sample collection at the admission. Receives: Diagnostic Test: Vaginal secretions collection; Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
total IGFBP1 in vaginal secretion at admission
Results of the tests detecting total IGFBP1 (positive/ negative)
Measured: Day 0
native IGFBP1 in vaginal secretion at admission
Results of the tests detecting native IGFBP1 (positive/ negative)
Measured: Day 0
PP14 in vaginal secretion at admission
PP14 values in vaginal secretion at admission dosed using the ELISA technique
Measured: Day 0
PIBF in vaginal secretion at admission
PIBF values in vaginal secretion at admission dosed using the ELISA technique
Measured: Day 0
PIBF in maternal serum at admission
PIBF values in maternal serum at admission dosed using the ELISA technique
Measured: Day 0
MIF in maternal serum at admission
MIF values in maternal serum at admission dosed using the ELISA technique
Measured: Day 0
Ultrasound length of cervix measured at the admission
Length of cervix was maesured by ultrasound at the admission (millmeters)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start10 Mar 2020
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Rupture of MembraneStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Biosynex Company
- Responsible party
- Sponsor
- Investigators
- Denis Gallot, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237142
- Sponsor's protocol ID
- RBHP 2019 GALLOT
- Other IDs
- 2019-A02306-51
- Acronym
- RECHOBIOL
- Status last verified
- Mar 2020
- First submitted
- 17 Jan 2020
- Last updated
- 16 Mar 2020
- 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 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Premature Rupture of Fetal Membranes: Cervical Ultrasound and Biological Markers to Diagnose Prematurity.
- ClinicalTrials.gov ID
- NCT04237142
- Acronym / sponsor ID
- RECHOBIOL / RBHP 2019 GALLOT
- Conditions
- Premature Rupture of Membrane
- Keywords
- Preterm premature rupture of membranes, Biomarkers, Latency period, Predictive Value of Tests
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Biosynex Company
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 23 Jan 2020 (actual)
- 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.
Our main hypothesis is to consider that the detection of biomarkers on admission combined with the length of the cervix would improve the prediction of the latency period in case of preterm premature rupture of membranes (pPROM). The primary purpose of the protocol is to assess the performance of these tests to predict a latency period <48 hours in case of pPROM.
Detailed description
Preterm premature rupture of membranes (pPROM) is defined as a spontaneous rupture before the start of labor ("premature" rupture) and before 37 weeks of gestation ("preterm"). pPROM concern 2-3% of pregnancies. It is the main cause of prematurity since it is responsible for 24 to 42% of preterm deliveries. The time between PROM and childbirth is named the latency period. Its total duration can vary from a few hours to several weeks. Childbirth occurs within 48 hours of rupture for 18 to 93% of cases, within 7 days for 56 to 96% and within 28 days for 78 to 100%. The earlier PROM occurs during pregnancy, the longer the latency period is. The factors associated with a shorter latency period are: cervical changes during admission for pPROM, a shortened cervix on ultrasound or a threat of premature delivery prior to PROM, the existence of uterine contractions, oligoamnios, and the occurrence of a materno-fetal complication of pPROM.
In a pPROM situation, a prolonged latency period improves the neonatal prognosis by increasing the gestational age of birth, gives the possibility of administering the corticosteroid treatment of fetal pulmonary maturation and also allows an in utero transfer in an adapted maternity.
Several studies have shown a correlation between the length of the cervix during rupture and the latency period in the context of pPROM.
To date, there are no effective biomarkers used in current practice to predict this latency period.
We want to assess the diagnostic performance of different vaginal (PIBF / PP14 / IGFBP1 native and total) and serum (PIBF / MIF) markers as well as the ultrasound length of the cervix to predict the duration of this latency period in order to better anticipate the risk of prematurity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible patients who had consented to participate | Experimental | Diagnostic Test: Vaginal secretions collection, Diagnostic Test: Blood sampleEligible patients who had consented to participate to the study, namely parturient admitted to the Clermont-Ferrand Hospital maternity for preterm premature rupture of membranes between 24+0 and 36+4 gestation week with cervical dilation < 4cm and without known uterine malformation, fetal malformation, placenta previa or abundant metrorrhagia. Patients underwent vaginal swabbing and blood sample collection at the admission. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Parturient admitted to the Clermont-Ferrand Hospital maternity for preterm premature rupture of membranes between 24+0 and 36+4 gestation week.
- Capacity to give informed consent.
- Coverage by a French social security scheme.
Key exclusion criteria (9 listed)
- Refusal to participate
- pPROM formally occurred more than 24 hours ago (free flow or positive breakage test)
- Cervical dilatation ≥ 4 cm
- Multiple Pregnancy
- Known uterine malformation
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 |
|---|---|---|
| Vaginal secretions collectionVaginal secretions are collected under speculum with a swab (10 seconds of impregnation of the swab). The swab is immersed in a tube containing an extraction buffer for 10 seconds. The tube is mixed and sent to the laboratory for subsequent analysis of biomarkers (IGFBP1 T/N, PIBF, PP14) and storage. | Diagnostic test | Eligible patients who had consented to participate |
| Blood sample2 tubes of blood sample were collected and sent to the laboratory for serum storage and biomarkeurs assay (PIBF and MIF) | Diagnostic test | Eligible patients who had consented to participate |
Primary outcome
total IGFBP1 in vaginal secretion at admission
Time frame: Day 0
Results of the tests detecting total IGFBP1 (positive/ negative)
native IGFBP1 in vaginal secretion at admission
Time frame: Day 0
Results of the tests detecting native IGFBP1 (positive/ negative)
PP14 in vaginal secretion at admission
Time frame: Day 0
PP14 values in vaginal secretion at admission dosed using the ELISA technique
PIBF in vaginal secretion at admission
Time frame: Day 0
PIBF values in vaginal secretion at admission dosed using the ELISA technique
PIBF in maternal serum at admission
Time frame: Day 0
PIBF values in maternal serum at admission dosed using the ELISA technique
MIF in maternal serum at admission
Time frame: Day 0
MIF values in maternal serum at admission dosed using the ELISA technique
Ultrasound length of cervix measured at the admission
Time frame: Day 0
Length of cervix was maesured by ultrasound at the admission (millmeters)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
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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.
Denis Gallot principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal secretions collection and Blood sample in people with Premature Rupture of Membrane, run by University Hospital, Clermont-Ferrand 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 3 inclusion and 9 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 16 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total IGFBP1 in vaginal secretion at admission (time frame: Day 0). The study lists 7 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 16 Mar 2020.