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Clinical Trials/NL-OMON47528
NL-OMON47528
Recruiting
Phase 3

Pessary or Cerclage to prevent preterm delivery in women with short cervical length with and a history of preterm birth. - PC Study

Academisch Medisch Centrum0 sites350 target enrollmentTBD
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Conditionspreterm birthpreterm delivery10028920

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
preterm birth
Sponsor
Academisch Medisch Centrum
Enrollment
350
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Singleton pregnancy
  • •2\. History of preterm birth before 34 weeks of gestation
  • •3\. Cervical length of 25mm or less on transvaginal ultrasound before 24 weeks
  • •Indication for primary cerclage before 16 weeks in current pregnancy based on
  • •obstetric history, according to local protocol

Exclusion Criteria

  • •\-placenta previa
  • •\-vasa previa
  • •\-age less than 18 years
  • •\-inability to give informed consent
  • •\-identified major congenital abnormalities
  • •\-Premature Prelabour Rupture of the Membranes (PPROM)
  • •\-Cervical dilatation 3cm or more
  • •\-Signs of infection or fetal distress

Outcomes

Primary Outcomes

Not specified

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