Back to resultsPartoSure to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Partosure TTD test
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Partosure TTD test, CL, ART, SN, SP, PPV, NPV
Eligibility Criteria
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.
Sites / Locations
- My Duc HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Partosure TTD Test
Arm Description
PartoSure TTD test will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02576418
First Posted
October 12, 2015
Last Updated
September 7, 2017
Sponsor
Vietnam National University
1. Study Identification
Unique Protocol Identification Number
NCT02576418
Brief Title
PartoSure to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)
Official Title
Evaluation of the PartoSure Time to Delivery (TTD) Test to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vietnam National University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Partosure TTD test, CL, ART, SN, SP, PPV, NPV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Partosure TTD Test
Arm Type
Experimental
Arm Description
PartoSure TTD test will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.
Intervention Type
Other
Intervention Name(s)
Partosure TTD test
Intervention Description
PartoSure TTD test and CL will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.
Primary Outcome Measure Information:
Title
The accuracy of c(SN, SP, PPV, NPV) in predicting delivery within 7 or 14 days from testing
Description
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.
Time Frame
7 or 14 days from testing
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tuong M Ho, Doctor
Phone
+ 84 903633377
Email
homanhtuong@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anh H Dang, MSc.
Phone
+84 908 302412
Email
anh.dh@myduchospital.vn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuong M Ho, Doctor
Organizational Affiliation
Research Center for Genetics and Reproductive Health
Official's Role
Study Director
Facility Information:
Facility Name
My Duc Hospital
City
Ho Chi Minh City
State/Province
Ward 13. Tan Binh District
ZIP/Postal Code
70000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vinh Q Dang, MD
Phone
+84 908225481
Email
bsvinh.dq@myduchospital.vn
First Name & Middle Initial & Last Name & Degree
Anh H Dang, MSc
Phone
+ 84 908302412
Email
anh.dh@myduchospital.vn
12. IPD Sharing Statement
Learn more about this trial
PartoSure to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)
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