Clinical trial NCT05742997: 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
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Birth
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value
timeFrame: 48 hours
measure: Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value
timeFrame: 7 days
measure: Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
References: