InfertilityNCT02576418
PartoSure to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)
A study testing Partosure TTD test in people with Infertility, run by Vietnam National University at 1 site in Vietnam.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Partosure TTD test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteVietnam
- Study dates
- Oct 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Digital exam prior to specimen collection.
- A symptom not associated with idiopathic threatened preterm delivery (e.g trauma)
- Enrollment in a tocolytic study.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
My Duc Hospital
Ho Chi Minh City, Ward 13. Tan Binh District, 70000
Vinh Q Dang, MD, +84 908225481, bsvinh.dq@myduchospital.vn
Anh H Dang, MSc, + 84 908302412, anh.dh@myduchospital.vn
About this study
Official title: 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)
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.
- Conditions
- Infertility
- Being tested
- Partosure TTD test
- Keywords
- Partosure TTD test, CL, ART, SN, SP, PPV, NPV
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partosure TTD testOther
PartoSure TTD test and CL will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.
| Study group | Role | What they receive |
|---|---|---|
| Partosure TTD Test | Experimental | PartoSure TTD test will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated. Receives: Other: Partosure TTD test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 or 14 days from testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vietnam National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manh Tuong Ho, Vietnam National University
- Investigators
- Tuong M Ho, Doctor, Study director, Research Center for Genetics and Reproductive Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576418
- Sponsor's protocol ID
- NCKH/CGRH_08_2015
- Status last verified
- Sep 2017
- First submitted
- 12 Oct 2015
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the PartoSure Time to Delivery (TTD) Test to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)
- ClinicalTrials.gov ID
- NCT02576418
- Acronym / sponsor ID
- NCKH/CGRH_08_2015
- Conditions
- Infertility
- Keywords
- Partosure TTD test, CL, ART, SN, SP, PPV, NPV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vietnam National UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partosure TTD Test | Experimental | Other: Partosure TTD testPartoSure TTD test will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partosure TTD testPartoSure TTD test and CL will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated. | Other | Partosure TTD Test |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuong M Ho, Doctor study director
Research Center for Genetics and Reproductive Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partosure TTD test in people with Infertility, run by Vietnam National University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuong M Ho, Doctor (+ 84 903633377, homanhtuong@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.