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

• ClinicalTrials.gov Identifier: NCT03530332
• Recruitment Status: Terminated
• First Posted: May 21, 2018
• Last Update Posted: February 17, 2020
• Sponsor: Ware Branch
• Collaborator: Sera Prognostics, Inc.
• Information provided by (Responsible Party): Ware Branch, Intermountain Health Care, Inc.

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1208 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
• Actual Primary Completion Date: February 17, 2019
• Actual Study Completion Date: August 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Gestational age at delivery [ Time Frame: At delivery ]
2. Neonatal Intensive Care Unit (NICU) length of stay only among neonates who were admitted to the NICU [ Time Frame: Up to 1 year post delivery ]
3. Length of stay among all neonates (including NICU and nursery) [ Time Frame: Up to 1 year post delivery ]
4. Neonatal costs [ Time Frame: Up to 1 year post delivery ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Utah

Intermountain Medical Center

Murray, Utah, United States, 84107

McKay-Dee Hospital

Ogden, Utah, United States, 84403

Utah Valley Hospital

Provo, Utah, United States, 84604

LDS Hospital

Salt Lake City, Utah, United States, 84143

Sponsors and Collaborators

Ware Branch

Sera Prognostics, Inc.

Investigators

• Principal Investigator: Ware Branch, M.D.; Intermountain Health Care, Inc.

More Information

• Responsible Party: Ware Branch, Medical Dir Sr - Women/Newborn, Intermountain MFM Specialist, Intermountain Health Care, Inc.
• ClinicalTrials.gov Identifier: NCT03530332
• Other Study ID Numbers: PREVENT-PTB Protocol 1.02
• First Posted: May 21, 2018
• Last Update Posted: February 17, 2020
• Last Verified: February 2020

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