Status:
TERMINATED
Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM)
Lead Sponsor:
Obstetrix Medical Group
Conditions:
Fetal Membranes, Premature Rupture
Eligibility:
FEMALE
18-60 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether retention of cervical cerclage after PPROM improves latency (without a significant increase in chorioamnionitis) and lessens neonatal morbidity.
Detailed Description
The placement of cervical cerclage is standard of care for women who experience incompetent cervix. Treadwell et al, published the largest retrospective review of 482 patients receiving cerclage (364 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00201656
Start Date
November 1 2004
End Date
April 1 2014
Last Update
December 19 2014
Active Locations (23)
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1
Desert Good Samaritan Hospital
Mesa, Arizona, United States, 85202
2
Banner Good Samaritan Hospital
Phoenix, Arizona, United States, 85006
3
Tucson Medical Center
Tucson, Arizona, United States, 85712
4
Saddleback Memorial Medical Center
Laguna Hills, California, United States, 92653