PartoSure to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)
|ClinicalTrials.gov Identifier: NCT02576418|
Recruitment Status : Unknown
Verified September 2017 by Manh Tuong Ho, Vietnam National University.
Recruitment status was: Recruiting
First Posted : October 15, 2015
Last Update Posted : September 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Other: Partosure TTD test||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the PartoSure Time to Delivery (TTD) Test to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Partosure TTD Test
PartoSure TTD test will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.
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.
- The accuracy of c(SN, SP, PPV, NPV) in predicting delivery within 7 or 14 days from testing [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576418
|Contact: Tuong M Ho, Doctor||+ 84 firstname.lastname@example.org|
|Contact: Anh H Dang, MSc.||+84 908 email@example.com|
|Study Director:||Tuong M Ho, Doctor||Research Center for Genetics and Reproductive Health|