Clinical trial NCT02576418: PartoSure to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)
Official title: Evaluation of the PartoSure Time to Delivery (TTD) Test to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: Partosure TTD test
CL
ART
SN
SP
PPV
NPV
Lead sponsor: Vietnam National University
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The accuracy of c(SN, SP, PPV, NPV) in predicting delivery within 7 or 14 days from testing
timeFrame: 7 or 14 days from testing
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: My Duc Hospital
state: Ward 13. Tan Binh District
Study officials:
affiliation: Research Center for Genetics and Reproductive Health
name: Tuong M Ho, Doctor
role: STUDY_DIRECTOR
References: