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Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix

NCT03251729 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2024-04-19

No results posted yet for this study

Summary

The aim of this study is to evaluate the efficacy of cervical cerclage in prevention of spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length (\<=25mm) and without prior spontaneous preterm birth

Conditions

  • Premature Birth

Interventions

PROCEDURE

Cervical cerclage

Transvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks

DRUG

Vaginal progesterone

Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-22
Primary Completion
2024-02-20
Completion
2024-02-20
FDA Drug
Yes

Countries

  • United States
  • Italy

Study Locations

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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 NCT03251729 on ClinicalTrials.gov