Premature preterm rupture of membranes
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time frame |
|---|---|
| NICU stay Birth weight EGA at delivery Postpartum endometritis Maternal sepsis | — |
Countries
Netherlands