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NCT03151330
Serum Assessment of Preterm Birth Outcomes Compared to Historical Controls: AVERT PRETERM TRIAL
NA trial testing Screened Arm in Preterm Birth in 1,873 participants. Completed in 1 June 2024.
16 March 2020
Quick facts
| Lead sponsor | Christiana Care Health Services |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 1,873 |
| Start date | 15 June 2018 |
| Primary completion | 16 March 2020 |
| Estimated completion | 1 June 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Screened Arm
Conditions studied
- Preterm Birth — all drugs for Preterm Birth →
Sponsor
Christiana Care Health Services — full company profile →
Who can join
18 and older, female only, with Preterm Birth. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: 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 modalities. Hypothesis: A cohort of pregnancies who are screened using the PreTRM® test around 20 weeks gestation in which a bundle of interventions is given for elevated PreTRM® risk will show either decreased neonatal morbidity/and mortality (measured as a composite score, "NMI"), or decreased length of neonatal stay in the hospital (NNOLOS). Secondarily, they will show an increase in gestational age at birth (GAB) and a reduction in length of neonatal NICU stay (NICULOS), compared to an unscreened historical control group. Study Design Type: Prospective cohort study of screened women compared to a historical control of 10000 women.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Neonatal Outcomes after Maternal Biomarker-Guided Preterm Birth Intervention: The AVERT PRETERM Trial.
Hoffman MK, Kitto C, Zhang Z, Shi J, et al · · 2024 · PMID 39061599 · DOI 10.3390/diagnostics14141462 -
Neonatal outcomes after maternal biomarker-guided preterm birth intervention: the AVERT PRETERM trial
Hoffman MK, Kitto C, Zhang Z, Shi J, et al · · 2023 · DOI 10.1101/2023.09.13.23295503
Verify or expand the search:
- PubMed search for NCT03151330
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Christiana Care Health Services trials
Trials by the same sponsor.
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- NCT05547139 — Impact of Extended CPAP on Bronchopulmonary Dysplasia · NA · completed
- NCT04739683 — Cervical Ripening With Foley Bulb Versus Dilapan-S at Home · NA · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03151330 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Christiana Care Health Services
- Last refreshed: 5 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03151330.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing