ClinicalTrials.gg
Status unknownNCT02576418Updated Sep 11, 2017

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

An interventional study of Partosure TTD test in Infertility, sponsored by Vietnam National University. Status unknown at 1 site in Vietnam. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-09-11.

Sponsored by Vietnam National University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
01

Study 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)

Read the 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.
02

Conditions studied

  • Infertility

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Keywords

  • Partosure TTD test
  • CL
  • ART
  • SN
  • SP
  • PPV
  • NPV
03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's planned enrollment of 100 is below the median of 135 across 1,412 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Vietnam National University is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 or 14 days from testing

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02576418
Lead sponsor
Vietnam National University
Responsible party
Manh Tuong Ho (Doctor, Vietnam National University) — Principal investigator
First posted
Oct 15, 2015
Start date
Oct 2015
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Sep 11, 2017

Study contacts

Tuong M Ho, Doctor
Contact
homanhtuong@yahoo.com
+ 84 903633377
Anh H Dang, MSc.
Contact
anh.dh@myduchospital.vn
+84 908 302412
Tuong M Ho, Doctor
study director · Research Center for Genetics and Reproductive Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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