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

Vietnam National University

Status

Unknown

Conditions

Infertility

Treatments

Other: Partosure TTD test

Study type

Interventional

Funder types

Other

Identifiers

NCT02576418

NCKH/CGRH_08_2015

Details and patient eligibility

About

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)

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.