Infertility Clinical Trial
Official title:
Evaluation of the PartoSure Time to Delivery (TTD) Test to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)
To calculate sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value (NPV) of PartoSure TTD test in predicting delivery within 7 or 14 days from testing and to compare it with cervical length (CL) measurement by transvaginal ultrasound (15 mm cut-off)
- This trial is a prospective observational study.
- Pregnancies after ART between 20 0/7 and 36 6/7 weeks with symptoms of preterm labor,
clinically intact membranes, cervical dilatation of ≤ 2 cm will be invited to
participate to the study. Signed consent form is required to be able to participate to
the study.
- PartoSure and CL will be performed on all patients and the test-to-spontaneous-delivery
interval will be calculated.
- Trial Population:Pregnancies after ART between 20 0/7 and 36 6/7 weeks with symptoms of
preterm labor are hospitalized at My Duc hospital from October 2015 to April 2016. The
sample size for this trial of 100 subjects.
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