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

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 TTD test (Time To Delivery)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46986

Enrollment

196

Registered

2014-05-13

Start date

2014-12-31

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pre term labor (PTL) threatening early birth

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: signs and symptoms or complaints suggestive of preterm labor (PTL) gestational age between 20 and 37 weeks

Exclusion criteria

Exclusion criteria: Rupture of fetal membranes (ROM) receiving tocolytic medication prior collection of cervicovaginal specimens cervical dilatation > 3 cm

Design outcomes

Primary

Measure	Time frame
SN, SP, PPV, and NPV for the novel kit for the detection of PAMG-1, cervical length measurements by trans-vaginal ultrasound ( 1 cm, and contraction frequency >= 8 per hour for the following presentation-to-delivery time intervals: a.	—

Secondary

Measure	Time frame
2. Association between results of the above tests and the following outcomes: a. Delivery	—

Countries

Netherlands

Outcome results