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

Preterm Birth Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05742997
• Other study ID #: CTU202071
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2023
• Source: Ziekenhuis Oost-Limburg
• Contact: Caroline Van Holsbeke, MD, PhD
• Phone: 003289327521
• Email: caroline.vanholsbeke[@]zol.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: October 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Birth

Intervention

Device:
• PartoSure
Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1
• Fetal Fibronectine
Diagnostic Kit for the Detection of Fetal Fibronectine

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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