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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Manh Tuong Ho, Vietnam National University

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)

Condition or disease Intervention/treatment Phase
Infertility Other: Partosure TTD test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576418


Contacts
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Contact: Tuong M Ho, Doctor + 84 903633377 homanhtuong@yahoo.com
Contact: Anh H Dang, MSc. +84 908 302412 anh.dh@myduchospital.vn

Locations
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Vietnam
My Duc Hospital Recruiting
Ho Chi Minh City, Ward 13. Tan Binh District, Vietnam, 70000
Contact: Vinh Q Dang, MD    +84 908225481    bsvinh.dq@myduchospital.vn   
Contact: Anh H Dang, MSc    + 84 908302412    anh.dh@myduchospital.vn   
Sponsors and Collaborators
Vietnam National University
Investigators
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Study Director: Tuong M Ho, Doctor Research Center for Genetics and Reproductive Health
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Responsible Party: Manh Tuong Ho, Doctor, Vietnam National University
ClinicalTrials.gov Identifier: NCT02576418    
Other Study ID Numbers: NCKH/CGRH_08_2015
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Keywords provided by Manh Tuong Ho, Vietnam National University:
Partosure TTD test
CL
ART
SN
SP
PPV
NPV
Additional relevant MeSH terms:
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Infertility
Premature Birth
Genital Diseases, Male
Genital Diseases, Female
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications