Infertility
Conditions
Keywords
Partosure TTD test, CL, ART, SN, SP, PPV, NPV
Brief 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.
Interventions
OTHERPartosure TTD test
PartoSure TTD test and CL will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.
Sponsors
Vietnam National University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The accuracy of c(SN, SP, PPV, NPV) in predicting delivery within 7 or 14 days from testing | 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. |
Countries
Vietnam
Contacts
Primary ContactTuong M Ho, Doctor
Backup ContactAnh H Dang, MSc.
Outcome results
None listed