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Cervical Pessary to Prevent Preterm Singleton Birth in High Risk Population

NCT04147117 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2020-06-04

No results posted yet for this study

Summary

DESIGN: Observational prospective study. INCLUSION CRITERIA: All women are 18 years old of age or older with high risk for preterm birth, based on clinical history, and between 18.0 weeks and 23.6 weeks of pregnancy. SAMPLE SIZE: 214 asymptomatic high risk pregnant women.

METHODOLOGY: Patient selection, obtaining of informed consent, randomization for cervical placement of pessary. Current follow-up until delivery. Pessary is removed at 37 week or before in some specific situations.

MAIN OUTCOME: sPTB \<370 weeks of gestation. SECONDARY OUTCOMES: Pregnancy outcomes and a neonatal composite morbidity. EXPECTED RESULTS: Cervical pessary reduces sPB below 37 weeks in high risk of preterm birth population.

Conditions

Interventions

DEVICE

Cervical pessary

Cervical pessary is a silicone ring with a smaller diameter to be fitted around the cervix and a larger diameter to fix the device to the pelvic floor. It modifies the direction of the cervix to the posterior vaginal wall.

Sponsors & Collaborators

  • Hospital Sant Joan de Deu

    lead OTHER

Principal Investigators

  • Silvia Irene Ferrero Martínez, MD,PhD · BCNatal | Hospital Sant Joan de Déu - Hospital Clínic

  • Montse Palacio Riera, MD,PhD · BCNatal | Hospital Clínic- Hospital Sant Joan de Déu

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2020-03-31
Completion
2020-12-31

Countries

  • Spain

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 NCT04147117 on ClinicalTrials.gov