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Search / Trial NCT03543475

Cervical Pessary for Prevention of Spontaneous Preterm Birth in Singleton Pregnancies With Arrested Preterm Labor

Launched by FEDERICO II UNIVERSITY · May 18, 2018

Trial Information

Current as of June 21, 2025

Terminated

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Singleton gestations
  • Diagnosis of arrested PTL
  • 18-50 years of age
  • TVU CL ≤25mm at the time of randomization
  • Exclusion Criteria:
  • Multiple gestations
  • Rupture of membranes at the time of randomization
  • Known major fetal structural (i.e. defined as those that are lethal or require prenatal or postnatal surgery) or chromosomal abnormality
  • Fetal death at the time of randomization
  • Cerclage in situ at the time of randomization
  • Pessary in situ at the time of randomization
  • Vaginal bleeding at the time of randomization
  • Women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years
  • Placenta previa and/or accreta
  • Ballooning of membranes outside the cervix into the vaginal or TVU CL = 0mm at the time of randomization
  • Painful and regular uterine contractions at the time of randomization

About Federico Ii University

Federico II University, located in Naples, Italy, is a prestigious academic institution with a strong emphasis on advanced research and clinical innovation. As a clinical trial sponsor, the university is committed to fostering the development of novel therapeutic interventions and enhancing patient care through rigorous scientific inquiry. With a multidisciplinary approach, Federico II University collaborates with healthcare professionals, researchers, and industry partners to conduct high-quality clinical trials that adhere to ethical standards and regulatory requirements. Its dedication to improving health outcomes is reflected in its robust research programs and commitment to translating scientific findings into clinical practice.

Locations

Naples, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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