NCT04301518 (PRIME) is a NA clinical trial of Multimodal intervention strategy in Preterm Labor, sponsored by Sera Prognostics, Inc..

Who is sponsoring NCT04301518?

NCT04301518 is sponsored by Sera Prognostics, Inc..

What drugs are being tested in NCT04301518?

Interventions in NCT04301518: Multimodal intervention strategy.

What condition does NCT04301518 study?

NCT04301518 studies Preterm Labor, Preterm Birth.

Is NCT04301518 still recruiting?

NCT04301518 is currently active, enrolled. Last updated 6 December 2024.

Last reviewed 2024-12-06 · How we verify

NCT04301518: PRIME

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs

Active, enrolled NA Last updated 6 December 2024

What this trial tests

NA trial testing Multimodal intervention strategy in Preterm Labor in 6,500 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 November 2020

Primary endpoint
6 December 2024

30 December 2026

Quick facts

Lead sponsor	Sera Prognostics, Inc.
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	6,500
Start date	6 November 2020
Primary completion	6 December 2024
Estimated completion	30 December 2026
Sites	18 locations across United States

Drugs / interventions tested

Multimodal intervention strategy

Conditions studied

Preterm Labor — all drugs for Preterm Labor →
Preterm Birth — all drugs for Preterm Birth →

Sponsor

Sera Prognostics, Inc.

Who can join

18 and older, female only, with Preterm Labor or Preterm Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This prospective, randomized, controlled study evaluates the safety and efficacy of a preterm birth (PTB) prevention strategy versus standard of care pregnancy management to reduce the incidence of adverse pregnancy outcomes.

Publications & conference data

1 peer-reviewed publication 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

Verify or expand the search:

Other recruiting trials for Preterm Labor

Currently open trials in the same condition.

NCT07015203 — The Combined First Trimester Screening · recruiting
NCT07263490 — PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients) · recruiting
NCT06053697 — Is the Vaginal Microbiome and Metabolome Associated With Spontaneous Preterm Birth (sPTB) in Multiple Pregnancies? · active not recruiting
NCT05698966 — Low Dose Antenatal Corticosteroids for Late Preterm Delivery · NA · recruiting
NCT06074601 — MIRACLE of LIFE Study · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04301518 (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 Sera Prognostics, Inc.
Last refreshed: 6 December 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/NCT04301518.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing