Prediction and Prevention of Preterm Birth (PREVENT-PTB Study)

Prediction and Prevention of Preterm Birth: A Prospective, Randomized Intervention Trial

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.

Study Overview

• Status: Terminated
• Conditions: Preterm Birth
• Intervention / Treatment: Diagnostic test: PreTRM test

Detailed Description

Preterm birth (PTB) remains the leading cause of neonatal mortality and long-term disability throughout the world. Recently treatments early in pregnancy such as progesterone, cervical support and maternal support have been demonstrated to delay delivery amongst at risk women. Nonetheless, the majority of women who are at risk are not identified using current screening methods.

Women who are 18 years or older, with a singleton pregnancy between 19 5/7 weeks and 20 6/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment and no history of prior preterm birth (delivery between 16 0/7 weeks and 37 6/7 weeks) will be invited to participate. Women who enroll will be randomized to screening and intervention for those at high risk of PTB or no screening and standard care. All participants will undergo sample collection, but the samples from the group randomized to "no screening' will not be analyzed until the end of the study (post-delivery of all neonates).

Women randomized to the intervention group will be screened using the PreTRM® test (Sera Prognostics, Inc.) at a large tertiary care center. Predicated upon the degree of risk, women will be treated according to a pre-specified algorithm. The outcomes of these women will be compared to a control group of women who do not receive screening at the same tertiary care center.

• Study Type: Interventional
• Enrollment (Actual): 1208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
    • Ogden, Utah, United States, 84403
      • McKay-Dee Hospital
    • Provo, Utah, United States, 84604
      • Utah Valley Hospital
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria

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

Exclusion Criteria

1. Subjects who have taken or plan to take progesterone beyond 13 6/7 weeks gestation prior to study enrollment OR
2. Any other medical conditions that put subject at increased risk of preterm birth in the judgment of the site investigator OR
3. The subject has a planned cerclage placement for the current pregnancy OR
4. Previously identified short cervix (less than 2.5 cm by transvaginal ultrasound) prior to enrollment OR
5. Known major structural fetal anomalies that may shorten pregnancy (e.g., anencephaly, holoprosencephaly, schizencephaly, gastroschisis, omphalocele, congenital diaphragmatic hernia) OR
6. Known fetal genetic anomalies that are incompatible with life (e.g., trisomy 13 or trisomy 18) OR
7. The subject has known elevated bilirubin levels (hyperbilirubinemia) OR
8. 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
9. A history of allergic reaction to aspirin or 17-OHPC injections OR
10. Subject does not plan to deliver at an Intermountain Healthcare hospital.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Treatment	Diagnostic test: PreTRM test; Blood test to determine risk of preterm birth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of spontaneous preterm birth	Before 37 weeks of pregnancy

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ware Branch
• Collaborators: Sera Prognostics, Inc.
• Investigators: Principal Investigator: Ware Branch, M.D., Intermountain Health Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2018
• Primary Completion (Actual): February 17, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 14, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Preterm Birth; Prematurity Prevention Clinic; Maternal-Fetal Medicine
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: PREVENT-PTB Protocol 1.02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No