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)

East Limburg Hospital

Status: Enrolling

Conditions: Preterm Birth

Treatments: Device: PartoSure; Device: Fetal Fibronectine

Study type: Interventional

Funder types: Other

Identifiers

NCT05742997

CTU202071

Details and patient eligibility

About

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.

Enrollment: 165 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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165 participants in 2 patient groups

PartoSure

Active Comparator group

Description:

Use of PartoSure to determine the risk of preterm birth

Treatment:

Device: PartoSure

Fetal Fibronectine (fFn)

Active Comparator group

Description:

Use of fFn to determine the risk of preterm birth

Treatment:

Device: Fetal Fibronectine