Clinical trial NCT03530332: 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
Overall status: TERMINATED
Phase: NA
Conditions: Preterm Birth
Keywords: Preterm Birth
Prematurity Prevention Clinic
Maternal-Fetal Medicine
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Sera Prognostics, Inc.
First posted: 2018-05-21
Enrollment: 1208
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of spontaneous preterm birth
timeFrame: Before 37 weeks of pregnancy
Secondary outcomes:
measure: Gestational age at delivery
timeFrame: At delivery
measure: Neonatal Intensive Care Unit (NICU) length of stay only among neonates who were admitted to the NICU
timeFrame: Up to 1 year post delivery
measure: Length of stay among all neonates (including NICU and nursery)
timeFrame: Up to 1 year post delivery
measure: Neonatal costs
timeFrame: Up to 1 year post delivery
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Ogden
country: United States
facility: McKay-Dee Hospital
state: Utah
city: Provo
country: United States
facility: Utah Valley Hospital
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Ware Branch, M.D.
role: PRINCIPAL_INVESTIGATOR
References: