Skip to content

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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38330
Enrollment
40
Registered
2012-09-18
Start date
2013-12-16
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature preterm rupture of membranes

Interventions

Retention of cerclage.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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

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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
NICU stay Birth weight EGA at delivery Postpartum endometritis Maternal sepsis

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)