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

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ClinicalTrials.gov Identifier: NCT03530332
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : June 27, 2018
Sponsor:
Collaborator:
Sera Prognostics, Inc.
Information provided by (Responsible Party):
Ware Branch, Intermountain Health Care, Inc.

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.

Condition or disease Intervention/treatment Phase
Preterm Birth Diagnostic Test: PreTRM test Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prediction and Prevention of Preterm Birth: A Prospective, Randomized Intervention Trial
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2023

Arm Intervention/treatment
Experimental: Treatment Diagnostic Test: PreTRM test
Blood test to determine risk of preterm birth

No Intervention: Control



Primary Outcome Measures :
  1. Incidence of spontaneous preterm birth [ Time Frame: Before 37 weeks of pregnancy ]

Secondary Outcome Measures :
  1. Proportion of any preterm birth [ Time Frame: Before 37 weeks of pregnancy ]
  2. Total length of hospital stay for spontaneous preterm birth [ Time Frame: 154 days ]
  3. Total length of hospital stay for any preterm birth [ Time Frame: 154 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530332


Contacts
Contact: Ware Branch, M.D. (801)507-7400 ware.branch@imail.org
Contact: M. Sean Esplin, M.D. (801)507-7400 sean.esplin@imail.org

Locations
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: T. Flint Porter, MD         
McKay-Dee Hospital Recruiting
Ogden, Utah, United States, 84403
Contact: Robert Andres, MD         
Utah Valley Hospital Recruiting
Provo, Utah, United States, 84604
Contact: M. Sean Esplin, MD         
LDS Hospital Recruiting
Salt Lake City, Utah, United States, 84143
Contact: Ware Branch, MD         
Sponsors and Collaborators
Ware Branch
Sera Prognostics, Inc.
Investigators
Principal Investigator: Ware Branch, M.D. Intermountain Health Care, Inc.

Responsible Party: Ware Branch, Medical Dir Sr - Women/Newborn, Intermountain MFM Specialist, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT03530332     History of Changes
Other Study ID Numbers: PREVENT-PTB Protocol 1.02
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Ware Branch, Intermountain Health Care, Inc.:
Preterm Birth
Prematurity Prevention Clinic
Maternal-Fetal Medicine

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications