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)

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth
• Intervention / Treatment: Device: PartoSure; Device: Fetal Fibronectine

• Study Type: Interventional
• Enrollment (Anticipated): 165
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline Van Holsbeke, MD, PhD; Phone Number: 003289327521; Email: caroline.vanholsbeke@zol.be
• Study Contact Backup: Name: Els Papy, Msc; Phone Number: 0032889327530; Email: els.papy@zol.be

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Recruiting
      • Ziekenhuis Oost-Limburg
      • Contact: Els Papy, Msc; Phone Number: 003289327530; Email: els.papy@zol.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PartoSure; Use of PartoSure to determine the risk of preterm birth	Device: PartoSure; Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1
Active Comparator: Fetal Fibronectine (fFn); Use of fFn to determine the risk of preterm birth	Device: Fetal Fibronectine; Diagnostic Kit for the Detection of Fetal Fibronectine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ziekenhuis Oost-Limburg

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: CTU202071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No