Preterm Birth
Conditions
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.
Interventions
DEVICEPartoSure
Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1
DEVICEFetal Fibronectine
Diagnostic Kit for the Detection of Fetal Fibronectine
Sponsors
Ziekenhuis Oost-Limburg
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value | 48 hours | 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. |
Countries
Belgium
Contacts
Primary ContactCaroline Van Holsbeke, MD, PhD
Backup ContactEls Papy, Msc
Outcome results
None listed