Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM)

Stopped early · Phase 4

Conditions studied: Fetal Membranes, Premature Rupture

In brief

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.

Key facts

Study ID

NCT00201656

Run by

Obstetrix Medical Group

People needed

58

Starts

2004-11-01

Expected to finish

2014-04-01

Last updated by the study team

2014-12-19

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Desert Good Samaritan Hospital — Mesa, Arizona, United States
• Banner Good Samaritan Hospital — Phoenix, Arizona, United States
• Tucson Medical Center — Tucson, Arizona, United States
• Saddleback Memorial Medical Center — Laguna Hills, California, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• University of Southern California-Irvine Medical Center — Orange, California, United States
• Good Samaritan Hospital — San Jose, California, United States
• Swedish Medical Center — Denver, Colorado, United States
• Presbyterian/St Luke's Hospital — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• Yale New-Haven Medical Center — New Haven, Connecticut, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Lousiana State University Health Science — Shreveport, Louisiana, United States
• Hutzel Women's Hospital — Detroit, Michigan, United States
• Saint Luke's Hospital, Kansas City — Kansas City, Missouri, United States
• Sunrise Medical Center — Las Vegas, Nevada, United States
• University of Rochester Medical Center — Rochester, New York, United States
• The University Hospital — Cincinnati, Ohio, United States
• Sacred Heart Medical Center — Eugene, Oregon, United States
• Erlanger Medical Center — Chattanooga, Tennessee, United States
• Memorial Hermann Children's Hospital-Texas Center for Fetal Assessment — Houston, Texas, United States
• Evergreen Hospital — Kirkland, Washington, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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