- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03530332
Prediction and Prevention of Preterm Birth (PREVENT-PTB Study)
Prediction and Prevention of Preterm Birth: A Prospective, Randomized Intervention Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Utah
-
Murray, Utah, Förenta staterna, 84107
- Intermountain Medical Center
-
Ogden, Utah, Förenta staterna, 84403
- McKay-Dee Hospital
-
Provo, Utah, Förenta staterna, 84604
- Utah Valley Hospital
-
Salt Lake City, Utah, Förenta staterna, 84143
- LDS Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: Kontrollera
|
|
Experimentell: Behandling
|
Blood test to determine risk of preterm birth
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Incidence of spontaneous preterm birth
Tidsram: Before 37 weeks of pregnancy
|
Before 37 weeks of pregnancy
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Gestationsålder vid förlossningen
Tidsram: Vid leverans
|
Vid leverans
|
Neonatal Intensive Care Unit (NICU) length of stay only among neonates who were admitted to the NICU
Tidsram: Up to 1 year post delivery
|
Up to 1 year post delivery
|
Length of stay among all neonates (including NICU and nursery)
Tidsram: Up to 1 year post delivery
|
Up to 1 year post delivery
|
Neonatal costs
Tidsram: Up to 1 year post delivery
|
Up to 1 year post delivery
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Ware Branch, M.D., Intermountain Health Care, Inc.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PREVENT-PTB Protocol 1.02
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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