Removal versus Retention of Cerclage in Preterm Premature Rupture of Membranes.
Suspended
- Conditions
- Premature Preterm Rupture Of Membranes, removal versus retention of cerclage.
- Registration Number
- NL-OMON27694
- Lead Sponsor
- Academic Medical Center (AMC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 142
Inclusion Criteria
1. A previously placed prophylactic cerclage defined as any cerclage done ≤ 23+6/7 weeks including those done for previous history of cervical incompetence, asymptomatic cervical shortening (regardless of effacement) and asymptomatic cervical dilation ≤ 3 cm;
2. Spontaneous rupture of membranes 22+0/7 ¨C 32+6/7 weeks;
Exclusion Criteria
1. Active labor (>8 uterine contractions per hour);
2. Chorioamnionitis as defined by temp > 38oC plus fetal tachycardia or uterine tenderness;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine whether retention of cerclage after PPROM improves in terms of:<br /><br>1. Chorioamnionitis (temp > 38oC plus fetal tachycardia or uterine tenderness);<br /><br>2. Latency (the interval from membrane rupture to the onset of labor in days) without a significant increase in chorioamnionitis (temp > 38oC plus fetal tachycardia or uterine tenderness);<br /><br>3. Composite Neonatal Outcome:<br /><br>A. Fetal or neonatal death;<br /><br>B. Respiratory distress syndrome;<br /><br>C. Documented sepsis within 72 hours of delivery;<br /><br>D. Grade 3 or 4 intraventricular hemorrhage;<br /><br>E. Stage 2 or 3 necrotizing enterocolitis.
- Secondary Outcome Measures
Name Time Method To compare these treatments in terms of:<br /><br>1. NICU stay;<br /><br>2. Birth weight;<br /><br>3. Estimated gestational age at delivery;<br /><br>4. Postpartum endometritis;<br /><br>5. Maternal sepsis.