Back to resultsPrediction and Prevention of Preterm Birth (PREVENT-PTB Study)
Primary Purpose
Preterm Birth
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PreTRM test
Sponsored by
About this trial
This is an interventional prevention trial for Preterm Birth focused on measuring Preterm Birth, Prematurity Prevention Clinic, Maternal-Fetal Medicine
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Sites / Locations
- Intermountain Medical Center
- McKay-Dee Hospital
- Utah Valley Hospital
- LDS Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
Outcomes
Primary Outcome Measures
Incidence of spontaneous preterm birth
Secondary Outcome Measures
Gestational age at delivery
Neonatal Intensive Care Unit (NICU) length of stay only among neonates who were admitted to the NICU
Length of stay among all neonates (including NICU and nursery)
Neonatal costs
Full Information
NCT ID
NCT03530332
First Posted
May 8, 2018
Last Updated
February 14, 2020
Sponsor
Ware Branch
Collaborators
Sera Prognostics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03530332
Brief Title
Prediction and Prevention of Preterm Birth (PREVENT-PTB Study)
Official Title
Prediction and Prevention of Preterm Birth: A Prospective, Randomized Intervention Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Inadequate resources.
Study Start Date
May 14, 2018 (Actual)
Primary Completion Date
February 17, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ware Branch
Collaborators
Sera Prognostics, Inc.
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
Preterm Birth, Prematurity Prevention Clinic, Maternal-Fetal Medicine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Diagnostic Test
Intervention Name(s)
PreTRM test
Intervention Description
Blood test to determine risk of preterm birth
Primary Outcome Measure Information:
Title
Incidence of spontaneous preterm birth
Time Frame
Before 37 weeks of pregnancy
Secondary Outcome Measure Information:
Title
Gestational age at delivery
Time Frame
At delivery
Title
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
Title
Length of stay among all neonates (including NICU and nursery)
Time Frame
Up to 1 year post delivery
Title
Neonatal costs
Time Frame
Up to 1 year post delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ware Branch, M.D.
Organizational Affiliation
Intermountain Health Care, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
McKay-Dee Hospital
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Utah Valley Hospital
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Prediction and Prevention of Preterm Birth (PREVENT-PTB Study)
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