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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02576418
• Other study ID #: NCKH/CGRH_08_2015
• Status: Recruiting
• Phase: N/A
• First received: October 12, 2015
• Last updated: September 7, 2017
• Start date: October 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2017
• Source: Vietnam National University
• Contact: Tuong M Ho, Doctor
• Phone: + 84 903633377
• Email: homanhtuong[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
Vietnam	My Duc Hospital	Ho Chi Minh City	Ward 13. Tan Binh District

Sponsors (1)

Lead Sponsor	Collaborator
Vietnam National University

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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