PartoSure to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)
NCT ID: NCT02576418
Last Updated: 2017-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2015-10-31
2017-12-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Partosure TTD Test
PartoSure TTD test will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.
Partosure TTD test
PartoSure TTD test and CL will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.
Interventions
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Partosure TTD test
PartoSure TTD test and CL will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
FEMALE
No
Sponsors
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Vietnam National University
OTHER
Responsible Party
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Manh Tuong Ho
Doctor
Principal Investigators
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Tuong M Ho, Doctor
Role: STUDY_DIRECTOR
Research Center for Genetics and Reproductive Health
Locations
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My Duc Hospital
Ho Chi Minh City, Ward 13. Tan Binh District, Vietnam
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCKH/CGRH_08_2015
Identifier Type: -
Identifier Source: org_study_id
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