An interventional study of PartoSure and Fetal Fibronectine in Preterm Birth, sponsored by Ziekenhuis Oost-Limburg. Status unknown at 1 site in Belgium. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-24.
Sponsored by Ziekenhuis Oost-Limburg · Not applicable, Interventional, and Diagnostic
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 165 is above the median of 84 across 1,688 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Ziekenhuis Oost-Limburg is the lead sponsor of 66 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients presenting for emergency obstetrical care at an emergency room or labor \& delivery unit with signs, symptoms or complaints suggestive of preterm labor (PTL)
Exclusion Criteria:
Use of PartoSure to determine the risk of preterm birth
Device: PartoSure
Use of fFn to determine the risk of preterm birth
Device: Fetal Fibronectine
Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1
Diagnostic Kit for the Detection of Fetal Fibronectine
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.
Time frame: 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.
Time frame: 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.
Time frame: 14 days
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Ziekenhuis Oost-Limburg