Preterm BirthPartoSureNCT05742997
Evaluation of a Novel Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth in Women Presenting With Signs and Symptoms of Preterm Labor
A study testing PartoSure and Fetal Fibronectine in people with Preterm Birth, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
Currently, the American College of Obstetricians and Gynecologists (ACOG) indicate in their most recent Practice Bulletin on the Management of Preterm Labor that many tests to identify women at risk of preterm birth have been proposed and evaluated; however, only ultrasonography and fetal fibronectin testing have been… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- PartoSure and Fetal Fibronectine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2021to 31 Oct 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients presenting for emergency obstetrical care at an emergency room or labor \& delivery unit with signs, symptoms or complaints suggestive of preterm labor (PTL)
- Uterine contractions, with or without pain
- Intermittent lower abdominal pain
- Dull backache
- Pelvic pressure
- Bleeding during the second or third trimester
Show all 10Show fewer
- Menstrual-like or intestinal cramping, with or without diarrhea
- Patient is not "feeling right"
- Gestational age between 200/7 and 366/7
- Consenting to be part of the trial
Who cannot join
- Presented for regularly scheduled obstetrical care with symptoms
- < 18 years old and not emancipated consenting minor
- < 200/7 weeks of gestation or ≥ 37 weeks of gestation cervix length > 30 mm
- cervical dilatation > 3 centimeters
- overt rupture of the fetal membranes (ROM) as indicated by visualized leakage of fluid from the cervical os
- heavy vaginal bleeding
Show all 11Show fewer
- received tocolytic medications for treatment of threatened preterm delivery prior to collection of the cervicovaginal specimens or cervical length measurements
- suspected placenta previa
- cervical cerclage in place
- a symptom not associated with idiopathic threatened preterm delivery (e.g. trauma)
- digital exam prior to specimen collection
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Els Papy, Msc, 003289327530, els.papy@zol.be
About this study
Official title: Evaluation of a Novel Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth in Women Presenting With Signs and Symptoms of Preterm Labor.
Currently, the American College of Obstetricians and Gynecologists (ACOG) indicate in their most recent Practice Bulletin on the Management of Preterm Labor that many tests to identify women at risk of preterm birth have been proposed and evaluated; however, only ultrasonography and fetal fibronectin testing have been shown to have benefit. Ultrasonography to determine cervical length, fetal fibronectin testing, or a combination of both may be useful in determining which women are at high risk for preterm delivery. However, their clinical usefulness may rest primarily with their ability to identify women who are least likely to deliver (i.e. their negative predictive value). Therefore, there is an urgent need for a test with a high positive predictive value in order to accurately predict imminent delivery to allow for salutary intervention.
- Conditions
- Preterm Birth
- Being tested
- PartoSure, Fetal Fibronectine
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PartoSureDevice
Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1
Fetal FibronectineDevice
Diagnostic Kit for the Detection of Fetal Fibronectine
| Study group | Role | What they receive |
|---|---|---|
| PartoSure | Active comparator | Use of PartoSure to determine the risk of preterm birth Receives: Device: PartoSure |
| Fetal Fibronectine (fFn) | Active comparator | Use of fFn to determine the risk of preterm birth Receives: Device: Fetal Fibronectine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value (NPV) for the kit for the detection of PAMG-1, cervical length measurements by trans-vaginal ultrasound (<30 mm), and contraction frequency ≥ 8 per hour.
Measured: 48 hours
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value (NPV) for the kit for the detection of PAMG-1, cervical length measurements by trans-vaginal ultrasound (<30 mm), and contraction frequency ≥ 8 per hour.
Measured: 7 days
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value (NPV) for the kit for the detection of PAMG-1, cervical length measurements by trans-vaginal ultrasound (<30 mm), and contraction frequency ≥ 8 per hour.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Oct 2021
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Van Holsbeke, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742997
- Sponsor's protocol ID
- CTU202071
- Acronym
- PartoSure
- Status last verified
- Feb 2023
- First submitted
- 2 Mar 2022
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth in Women Presenting With Signs and Symptoms of Preterm Labor.
- ClinicalTrials.gov ID
- NCT05742997
- Acronym / sponsor ID
- PartoSure / CTU202071
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 24 Feb 2023 (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.
Currently, the American College of Obstetricians and Gynecologists (ACOG) indicate in their most recent Practice Bulletin on the Management of Preterm Labor that many tests to identify women at risk of preterm birth have been proposed and evaluated; however, only ultrasonography and fetal fibronectin testing have been shown to have benefit. Ultrasonography to determine cervical length, fetal fibronectin testing, or a combination of both may be useful in determining which women are at high risk for preterm delivery. However, their clinical usefulness may rest primarily with their ability to identify women who are least likely to deliver (i.e. their negative predictive value). Therefore, there is an urgent need for a test with a high positive predictive value in order to accurately predict imminent delivery to allow for salutary intervention.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PartoSure | Active comparator | Device: PartoSureUse of PartoSure to determine the risk of preterm birth |
| Fetal Fibronectine (fFn) | Active comparator | Device: Fetal FibronectineUse of fFn to determine the risk of preterm birth |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients presenting for emergency obstetrical care at an emergency room or labor \& delivery unit with signs, symptoms or complaints suggestive of preterm labor (PTL)
- Gestational age between 200/7 and 366/7
- Consenting to be part of the trial
Key exclusion criteria (11 listed)
- Presented for regularly scheduled obstetrical care with symptoms
- < 18 years old and not emancipated consenting minor
- < 200/7 weeks of gestation or ≥ 37 weeks of gestation cervix length > 30 mm
- cervical dilatation > 3 centimeters
- overt rupture of the fetal membranes (ROM) as indicated by visualized leakage of fluid from the cervical os
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 |
|---|---|---|
| PartoSureDiagnostic Kit for the Detection of Placental Alpha-Microglobulin-1 | Device | PartoSure |
| Fetal FibronectineDiagnostic Kit for the Detection of Fetal Fibronectine | Device | Fetal Fibronectine (fFn) |
Primary outcome
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value
Time frame: 48 hours
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value (NPV) for the kit for the detection of PAMG-1, cervical length measurements by trans-vaginal ultrasound (<30 mm), and contraction frequency ≥ 8 per hour.
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value
Time frame: 7 days
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value (NPV) for the kit for the detection of PAMG-1, cervical length measurements by trans-vaginal ultrasound (<30 mm), and contraction frequency ≥ 8 per hour.
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value
Time frame: 14 days
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value (NPV) for the kit for the detection of PAMG-1, cervical length measurements by trans-vaginal ultrasound (<30 mm), and contraction frequency ≥ 8 per hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Preterm Birth
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PartoSure and Fetal Fibronectine in people with Preterm Birth, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
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 10 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: status not confirmed, as of the sponsor's last update on 24 Feb 2023. 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 Belgium. 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 Caroline Van Holsbeke, MD, PhD (003289327521, caroline.vanholsbeke@zol.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value (time frame: 48 hours). The study lists 3 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 24 Feb 2023.