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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partosure TTD Test | Experimental | PartoSure TTD test will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partosure TTD test | Other | PartoSure TTD test and CL will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated. |
|
| 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 |
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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:
Exclusion Criteria:
To be eligible for enrollment in this study each subject must not meet any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tuong M Ho, Doctor | Contact | + 84 903633377 | homanhtuong@yahoo.com | |
| Anh H Dang, MSc. | Contact | +84 908 302412 | anh.dh@myduchospital.vn |
| Name | Affiliation | Role |
|---|---|---|
| Tuong M Ho, Doctor | Research Center for Genetics and Reproductive Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| My Duc Hospital | Recruiting | Ho Chi Minh City | Ward 13. Tan Binh District | 70000 | Vietnam |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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