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 Overview
=================
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.

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.

Conditions
-----------------
Preterm Birth

Intervention / Treatment
-----------------
* Device: PartoSure
* Device: Fetal Fibronectine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 |