Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM) (PROMCerclage)
Fetal Membranes, Premature Rupture
About this trial
This is an interventional treatment trial for Fetal Membranes, Premature Rupture focused on measuring PPROM, Cerclage, Preterm Premature Rupture of the Membranes with Cerclage
Eligibility Criteria
Inclusion Criteria: 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 Spontaneous rupture of membranes 22-32 weeks Singleton or twin gestation Shirodkar or McDonald cerclage in place > 1 week Exclusion Criteria: Active labor (> 8 uterine contractions [UCs] per hour) Chorioamnionitis as defined by temperature > 38 plus fetal tachycardia or uterine tenderness Placenta previa or undiagnosed vaginal bleeding Nonreassuring fetal status by nonstress test (NST) or biophysical profile (BPP) Mature pulmonary studies Positive gram stain, culture, white blood cells (WBC) > 30, or glucose < 14 on amniocentesis Major fetal anomaly Presentation > 48 hours after rupture of membranes abdominal cerclage Cerclage done for symptomatic cervical dilation (cervix dilated > 3 cm) Post amniocentesis membrane rupture (rupture which occurs within one week of amniocentesis)
Sites / Locations
- Desert Good Samaritan Hospital
- Banner Good Samaritan Hospital
- Tucson Medical Center
- Saddleback Memorial Medical Center
- Long Beach Memorial Medical Center
- University of Southern California-Irvine Medical Center
- Good Samaritan Hospital
- Swedish Medical Center
- Presbyterian/St Luke's Hospital
- Rose Medical Center
- Yale New-Haven Medical Center
- University of Illinois at Chicago
- Lousiana State University Health Science
- Hutzel Women's Hospital
- Saint Luke's Hospital, Kansas City
- Sunrise Medical Center
- University of Rochester Medical Center
- The University Hospital
- Sacred Heart Medical Center
- Erlanger Medical Center
- Memorial Hermann Children's Hospital-Texas Center for Fetal Assessment
- Evergreen Hospital
- Swedish Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
1 Retention of Cerclage
2 - Removal of Cerclage
Group one = Subject whose Cerclage is retained after randomization.
Group 2 = Subjects who will have cerclage removed after randomization