PartoSure to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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Evaluation of the PartoSure Time to Delivery (TTD) Test to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)

Conditions
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Infertility

Intervention / Treatment
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* Other: Partosure TTD test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible for enrollment into this trial, each female subject must fulfill all of the following criteria at the start of enrollment: Pregnancies after assisted reproductive technology include singleton and twins Between 20 0/7 and 36 6/7 weeks with symptoms of preterm labor including uterine contractions, intermittent lower abdominal pain and pelvic pressure. Clinically intact membranes. Cervical dilatation of ≤ 2 cm Agree to participate in the study, and to disclose any medical events to the investigator Have given written informed consent Exclusion Criteria: To be eligible for enrollment in this study each subject must not meet any of the following criteria: Vaginal bleeding Overt rupture of the fetal membranes as indicated by visualized leakage of fluid from the cervix Placenta previa Cervical cerclage in place Received tocolytic medications for treatment of threatened preterm delivery prior to collection of the cervicovaginal specimens or CL measurement. Digital exam prior to specimen collection. A symptom not associated with idiopathic threatened preterm delivery (e.g trauma) Enrollment in a tocolytic study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Partosure TTD Test<br>PartoSure TTD test will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated. | Other: Partosure TTD test<br>* PartoSure TTD test and CL will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy of c(SN, SP, PPV, NPV) in predicting delivery within 7 or 14 days from testing | SN, SP, PPV and NPV superiority of PartoSure TTD test compared to CL measurement via transvaginal ultrasound (15 mm cutoff) for the presentation-to-spontaneous-delivery time intervals of ≤ 7 days or 14 days. | 7 or 14 days from testing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Partosure TTD test, CL, ART, SN, SP, PPV, NPV