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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)

Primary Purpose

Preterm Birth

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
PartoSure
Fetal Fibronectine
Sponsored by
Ziekenhuis Oost-Limburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Preterm Birth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Ziekenhuis Oost-LimburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PartoSure

Fetal Fibronectine (fFn)

Arm Description

Use of PartoSure to determine the risk of preterm birth

Use of fFn to determine the risk of preterm birth

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 2, 2022
Last Updated
February 23, 2023
Sponsor
Ziekenhuis Oost-Limburg
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1. Study Identification

Unique Protocol Identification Number
NCT05742997
Brief 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
Acronym
PartoSure
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziekenhuis Oost-Limburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PartoSure
Arm Type
Active Comparator
Arm Description
Use of PartoSure to determine the risk of preterm birth
Arm Title
Fetal Fibronectine (fFn)
Arm Type
Active Comparator
Arm Description
Use of fFn to determine the risk of preterm birth
Intervention Type
Device
Intervention Name(s)
PartoSure
Intervention Description
Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1
Intervention Type
Device
Intervention Name(s)
Fetal Fibronectine
Intervention Description
Diagnostic Kit for the Detection of Fetal Fibronectine
Primary Outcome Measure Information:
Title
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value
Description
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
Title
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value
Description
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
Title
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Van Holsbeke, MD, PhD
Phone
003289327521
Email
caroline.vanholsbeke@zol.be
First Name & Middle Initial & Last Name or Official Title & Degree
Els Papy, Msc
Phone
0032889327530
Email
els.papy@zol.be
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Els Papy, Msc
Phone
003289327530
Email
els.papy@zol.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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