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

NCT02576418 | Unknown

• 1 other identifier: NCKH/CGRH_08_2015
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

Infertility

Keywords

Partosure TTD test; CL; ART; SN; SP; PPV; NPV

Outcome Measures

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.

  7 or 14 days from testing

Study Arms (1)

Partosure TTD Test

EXPERIMENTAL

PartoSure TTD test will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.

Other: Partosure TTD test

Interventions

Partosure TTD test OTHER

PartoSure TTD test and CL will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.

Partosure TTD Test

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vietnam National University: lead

Study Sites (1)

My Duc Hospital

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

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Tuong M Ho, Doctor

  Research Center for Genetics and Reproductive Health

  STUDY DIRECTOR

Central Study Contacts

Tuong M Ho, Doctor

CONTACT

+ 84 903633377; homanhtuong@yahoo.com

Anh H Dang, MSc.

CONTACT

+84 908 302412; anh.dh@myduchospital.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 15, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

VN (1)