Preterm BirthNCT03530332
Prediction and Prevention of Preterm Birth (PREVENT-PTB Study)
A study testing PreTRM test in people with Preterm Birth, run by Ware Branch at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- PreTRM test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,208 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 May 2018to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Intermountain Medical Center
Murray, Utah, 84107
McKay-Dee Hospital
Ogden, Utah, 84403
Utah Valley Hospital
Provo, Utah, 84604
LDS Hospital
Salt Lake City, Utah, 84143
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm Birth
- Being tested
- PreTRM test
- Keywords
- Preterm Birth, Prematurity Prevention Clinic, Maternal-Fetal Medicine
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreTRM testDiagnostic test
Blood test to determine risk of preterm birth
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Diagnostic Test: PreTRM test |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of spontaneous preterm birth
Measured: Before 37 weeks of pregnancy
Secondary outcomes (4)
Gestational age at delivery
Measured: At delivery
Neonatal Intensive Care Unit (NICU) length of stay only among neonates who were admitted to the NICU
Measured: Up to 1 year post delivery
Length of stay among all neonates (including NICU and nursery)
Measured: Up to 1 year post delivery
Neonatal costs
Measured: Up to 1 year post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start14 May 2018
- Primary completion17 Feb 2019
- Study completion30 Aug 2019
Why it stopped: Inadequate resources.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ware Branch
- Sponsor type
- University, hospital or other
- Collaborators
- Sera Prognostics, Inc.
- Responsible party
- Sponsor-investigator, Ware Branch, Intermountain Health Care, Inc.
- Investigators
- Ware Branch, M.D., Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530332
- Sponsor's protocol ID
- PREVENT-PTB Protocol 1.02
- Status last verified
- Feb 2020
- First submitted
- 8 May 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34399434
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Prevention of Preterm Birth: A Prospective, Randomized Intervention Trial
- ClinicalTrials.gov ID
- NCT03530332
- Acronym / sponsor ID
- PREVENT-PTB Protocol 1.02
- Conditions
- Preterm Birth
- Keywords
- Preterm Birth, Prematurity Prevention Clinic, Maternal-Fetal Medicine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate resources.
- Enrolment
- 1,208 participants (actual)
- Lead sponsor
- Ware BranchUniversity, hospital or other
- Collaborators
- Sera Prognostics, Inc.
- Study start
- 14 May 2018 (actual)
- Primary completion
- 17 Feb 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Diagnostic Test: PreTRM test |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PreTRM testBlood test to determine risk of preterm birth | Diagnostic test | Treatment |
Primary outcome
Incidence of spontaneous preterm birth
Time frame: Before 37 weeks of pregnancy
4 secondary outcomes
Gestational age at delivery
Time frame: At delivery
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
Length of stay among all neonates (including NICU and nursery)
Time frame: Up to 1 year post delivery
Neonatal costs
Time frame: Up to 1 year post delivery
Results and safety
The study was stopped early (reason given: Inadequate resources.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Derived from this study: PubMed 34399434Branch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ware Branch, M.D. principal investigator
Intermountain Health Care, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PreTRM test in people with Preterm Birth, run by Ware Branch at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate resources.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of spontaneous preterm birth (time frame: Before 37 weeks of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03530332, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.