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
Completed
- Conditions
- pre term labor (PTL)threatening early birth10026908
- Registration Number
- NL-OMON46986
- Lead Sponsor
- HAGAMEDICAL B.V.
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 110
Inclusion Criteria
signs and symptoms or complaints suggestive of preterm labor (PTL)
gestational age between 20 and 37 weeks
< 3 cm cervical dilatation
consenting to be part of tghe trial
Exclusion Criteria
Rupture of fetal membranes (ROM)
receiving tocolytic medication prior collection of cervicovaginal specimens
cervical dilatation > 3 cm
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>SN, SP, PPV, and NPV for the novel kit for the detection of PAMG-1, cervical<br /><br>length measurements by trans-vaginal ultrasound (<30 mm), cervical dilatation ><br /><br>1 cm, and contraction frequency >= 8 per hour for the following<br /><br>presentation-to-delivery time intervals:<br /><br>a. <= 48 hours<br /><br>b. <= 7 days<br /><br>c. <= 14 days</p><br>
- Secondary Outcome Measures
Name Time Method <p>2. Association between results of the above tests and the following outcomes:<br /><br>a. Delivery <37 weeks gestation<br /><br>b. Admission to NICU<br /><br>c. Histological chorioamnionitis<br /><br>d. Funisitis<br /><br>e. Respiratory distress syndrome<br /><br>f. Patent ductus arteriosus<br /><br>g. Neonatal sepsis<br /><br>h. Birthweight<br /><br>i. Perinatal death</p><br>