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
PartoSure
1 other identifier
interventional
165
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedFirst Submitted
Initial submission to the registry
March 2, 2022
CompletedFirst Posted
Study publicly available on registry
February 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedFebruary 24, 2023
February 1, 2023
1.9 years
March 2, 2022
February 23, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
14 days
Study Arms (2)
PartoSure
ACTIVE COMPARATORUse of PartoSure to determine the risk of preterm birth
Fetal Fibronectine (fFn)
ACTIVE COMPARATORUse of fFn to determine the risk of preterm birth
Interventions
Diagnostic Kit for the Detection of Fetal Fibronectine
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 2, 2022
First Posted
February 24, 2023
Study Start
October 1, 2021
Primary Completion
August 31, 2023
Study Completion
October 31, 2023
Last Updated
February 24, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share