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Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs

NCT04301518 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6500

Last updated 2024-12-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Multimodal intervention strategy

* Once weekly nurse support * 200 mg/daily micronized progesterone as vaginal suppository * 81 mg/daily low dose aspirin * two transvaginal ultrasounds * cerclage placement if cervical length is less than or equal to 10 mm prior to 24 weeks gestation

Sponsors & Collaborators

  • High Risk Pregnancy Center, Las Vegas, Nevada

    collaborator OTHER

  • Sera Prognostics, Inc.

    lead INDUSTRY

Principal Investigators

  • Brian Iriye, MD · High Risk Pregnancy Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-06
Primary Completion
2024-12-06
Completion
2026-12-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04301518 on ClinicalTrials.gov