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Clinical Trials/NL-OMON38330
NL-OMON38330
Completed
Phase 3

Removal versus Retention of Cerclage in Preterm Premature Rupture of Membranes. - PPROMCerclage

Academisch Medisch Centrum0 sites40 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Academisch Medisch Centrum
Enrollment
40
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •A previously placed prophylactic cerclage defined as any cerclage done \* 23w6d weeks including those done for previous history of cervical incompetence, asymptomatic cervical shortening (regardless of effacement) and asymptomatic cervical dilation \* 3 cm
  • •Spontaneous rupture of membranes 22w0d\-32w6d weeks
  • •Singleton or twin gestation
  • •Shirodkar or McDonald cerclage in place \* 1 week

Exclusion Criteria

  • •Active labor (\>8 UCs per hour)
  • •Chorioamnionitis \- defined by temp of \>38ºC, plus fetal tachycardia or uterine tenderness
  • •Placenta previa or undiagnosed vaginal bleeding
  • •Nonreassuring fetal status by NST or BPP
  • •Mature pulmonary studies
  • •\+ gram stain, culture, WBC \* 30, or glucose \* 14 on amniocentesis (amniocentesis optional)
  • •Major fetal anomaly
  • •Presentation \> 48 hours after rupture of membranes
  • •Abdominal cerclage
  • •Cerclage done for symptomatic cervical dilation (cervix dilated \> 3cm)

Outcomes

Primary Outcomes

Not specified

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