NCT02576418

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Vietnam National University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

* 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.

Conditions

• Infertility

Interventions

Type	Name	Description
OTHER	Partosure TTD test	PartoSure TTD test and CL will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-10-15
• Last updated: 2017-09-11

Locations

1 site across 1 country: Vietnam