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

Phase 3

Completed

Conditions: Premature preterm rupture of membranes
10010273

Registration Number: NL-OMON38330

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

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)
Post amniocentesis membrane rupture (rupture which occurs within one week of amniocentesis)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Latency<br /><br>Chorioamnionitis as defined by temp > 38°C plus fetal tachycardia or uterine<br /><br>tenderness<br /><br>Composite Neonatal Outcome * any one of the following (for twins, either<br /><br>infant) :<br /><br>Fetal or neonatal death<br /><br>Respiratory distress syndrome<br /><br>Documented sepsis within 72 hours of delivery<br /><br>Grade 3 or 4 intraventricular hemorrhage<br /><br>Stage 2 or 3 necrotizing enterocolitis</p><br>

Secondary Outcome Measures