A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor (TREETOP)

Prospective multicenter observational study to further develop and validate a preterm birth risk predictor, using a preterm cutoff at 37 0/7 weeks gestation and at 35 0/7 weeks gestation. A single maternal peripheral blood sample will be collected for analysis. Data related to potential risk factors for preterm birth will be obtained through maternal interview and review of medical records. Subjects will be followed through the delivery process to assess the course of pregnancy, labor, and to document any related maternal complications. Neonatal outcomes will be gathered from the medical record for up to 28 days of life or discharge, whichever occurs first.

I'M INTERESTED

This research study is led by Dr. Corina Schoen.

Contact: Laura Gebhardt, 413-794-2706

Participation details:

August 01, 2016
1026504
Pregnancy, OB Gyn
Baystate Medical Center, 759 Chestnut St, Springfield, MA

Ages Eligible for Study: 18 Years to 55 Years (Adult)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Study Population:

Pregnant women, 18 years or older, who are receiving prenatal care.

Inclusion Criteria:

  • Subject has singleton gestation
  • Subject is able to provide consent
  • Gestational age is confirmed by a documented crown rump length on an ultrasound performed at the study site within 6 0/7 weeks and 13 6/7 weeks gestation (first trimester)
  • Subject has no signs and/or symptoms of preterm labor and has intact membranes

Exclusion Criteria:

  • The subject has a planned cesarean section or induction of labor prior to 370/7 weeks of gestation
  • The subject has a planned cerclage placement for the current pregnancy
  • There is a known or suspected fetal anomaly or chromosomal abnormality
  • The subject has had a blood transfusion during the current pregnancy
Active
Observational