NCT03530332

Brief Summary

This research study is being done to find out whether a screening blood test can help identify women with an increased risk of preterm birth.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

May 14, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

May 8, 2018

Last Update Submit

February 14, 2020

Conditions

Preterm Birth

Keywords

Preterm BirthPrematurity Prevention ClinicMaternal-Fetal Medicine

Outcome Measures

Primary Outcomes (1)

  • Incidence of spontaneous preterm birth

    Before 37 weeks of pregnancy

Secondary Outcomes (4)

  • Gestational age at delivery

    At delivery

  • Neonatal Intensive Care Unit (NICU) length of stay only among neonates who were admitted to the NICU

    Up to 1 year post delivery

  • Length of stay among all neonates (including NICU and nursery)

    Up to 1 year post delivery

  • Neonatal costs

    Up to 1 year post delivery

Study Arms (2)

Treatment

EXPERIMENTAL
Diagnostic Test: PreTRM test

Control

NO INTERVENTION

Interventions

PreTRM testDIAGNOSTIC_TEST

Blood test to determine risk of preterm birth

Treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is greater than or equal to 18 years of age AND
  • Uncomplicated singleton intrauterine pregnancy less than 21 weeks estimated gestation AND
  • No medical contraindications to continuing pregnancy AND
  • No previous classical cesarean section AND
  • No known uterine anomaly AND
  • No history of cervical conization AND
  • No plan for cesarean section prior to 37 0/7 weeks gestation AND
  • No plan for induction of labor prior to 37 0/7 weeks gestation AND
  • Subject has no history of spontaneous preterm delivery AND
  • No prior PPROM less than 34 weeks AND
  • Subject has no signs and/or symptoms of preterm labor AND
  • Subject has intact membranes AND
  • Subject has not received a blood transfusion during the current pregnancy.

You may not qualify if:

  • Subjects who have taken or plan to take progesterone beyond 13 6/7 weeks gestation prior to study enrollment OR
  • Any other medical conditions that put subject at increased risk of preterm birth in the judgment of the site investigator OR
  • The subject has a planned cerclage placement for the current pregnancy OR
  • Previously identified short cervix (less than 2.5 cm by transvaginal ultrasound) prior to enrollment OR
  • Known major structural fetal anomalies that may shorten pregnancy (e.g., anencephaly, holoprosencephaly, schizencephaly, gastroschisis, omphalocele, congenital diaphragmatic hernia) OR
  • Known fetal genetic anomalies that are incompatible with life (e.g., trisomy 13 or trisomy 18) OR
  • The subject has known elevated bilirubin levels (hyperbilirubinemia) OR
  • The subject has taken or plans to take any of the following medications after the first day of the last menstrual period: Enoxaparin, heparin, heparin sodium, low molecular weight heparin, low dose aspirin OR
  • A history of allergic reaction to aspirin or 17-OHPC injections OR
  • Subject does not plan to deliver at an Intermountain Healthcare hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital

Ogden, Utah, 84403, United States

Location

Utah Valley Hospital

Provo, Utah, 84604, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Related Publications (1)

  • Branch DW, VanBuren JM, Porter TF, Holmgren C, Holubkov R, Page K, Burchard J, Lam GK, Esplin MS. Prediction and Prevention of Preterm Birth: A Prospective, Randomized Intervention Trial. Am J Perinatol. 2023 Jul;40(10):1071-1080. doi: 10.1055/s-0041-1732339. Epub 2021 Aug 16.

    PMID: 34399434DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Ware Branch, M.D.

    Intermountain Health Care, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Dir Sr - Women/Newborn, Intermountain MFM Specialist

Study Record Dates

First Submitted

May 8, 2018

First Posted

May 21, 2018

Study Start

May 14, 2018

Primary Completion

February 17, 2019

Study Completion

August 30, 2019

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(4)