A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Maricopa Integrated Health Systems, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject is 18 years of age or older
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
Investigator believes subject is willing to comply with study visits and procedures
Investigator believes the subject's delivery data will be available within 15 business days from delivery, and neonatal data will be available for data collection purposes within 15 business days from discharge

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
The subject has known elevated bilirubin levels (hyperbilirubinemia)
The subject has taken or plans to take any of the following medications during the current pregnancy:

Progesterone or progesterone-derivative medication after 13 6/7 weeks gestation
Enoxaparin, heparin, heparin sodium, low molecular weight heparin after first day of last menstrual period
The subject has participated in, or plans to participate in, an interventional treatment study during the current pregnancy
The current pregnancy was previously a multiple gestation that is now a single fetus due to reduction, vanishing twin, etc.

Treatment and study plan

Primary outcomes

Area under the receiver operator characteristic curve (AUROC) for prediction of preterm versus term birth using freshly collected specimens.

Time frame: Up to 30 months

Sponsors and collaborators

Lead sponsor

Sera Prognostics, Inc.

Industry

Registry information

Acronym: TREETOP

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Jun 1, 2016
Registry last updated: Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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