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

September 7, 2017 updated by: Manh Tuong Ho, Vietnam National University

Evaluation of the PartoSure Time to Delivery (TTD) Test to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Ward 13. Tan Binh District
      • Ho Chi Minh City, Ward 13. Tan Binh District, Vietnam, 70000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 or 14 days from testing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vietnam National University

Investigators

  • Study Director: Tuong M Ho, Doctor, Research Center for Genetics and Reproductive Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

October 14, 2015

First Posted (Estimate)

October 15, 2015

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 7, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCKH/CGRH_08_2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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