Clinical Trial: Cerclage for Prevention on Preterm Birth in Women With Placenta Previa

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Cerclage Placement for the Prevention of Preterm Birth in Women With Placenta Previa - A Multicenter Randomized Controlled Trial

Brief Summary: The purpose of the study is to compare the role of cervical cerclage versus expectant management in women with complete placenta previa (≥ 10mm over internal os) presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of pregnancy.

Detailed Summary: The purpose of this study is to perform a large multi-center randomized trial comparing the role of cervical cerclage versus expectant management in women with placenta previa presenting with shortened cervical length ( ≥ 10mm and ≤ 30mm) between 18w0d and 26w0d of gestation. In addition, the role of fetal fibronectin (fFN) for the prediction of preterm birth and hemorrhage will be elucidated. The hypothesis is that placement of a cervical cerclage between 18w0d to 26w0d in patients with a short cervix and complete placenta previa will decrease preterm birth as compared to expectantly managing these patients.
Sponsor: Obstetrix Medical Group

Current Primary Outcome: Gestational age (GA) at birth [ Time Frame: measure taken in the first 23 hours after birth. ]

Original Primary Outcome: Gestational age (GA) at birth [ Time Frame: within 23 hours after birth ]

Current Secondary Outcome:

• Newborn Birth weight [ Time Frame: measured within 1-2 days after birth ]
  Newborn Birth weight measure within 1-2 days after birth.
• Need for Maternal Blood Product replacement [ Time Frame: measured from the time participant is enrolled in the study until 30 days after delivery.(approximately 40 weeks) ]
  Maternal need for blood product replacement such as Fresh Frozen Plasma.
• Number of participants delivering prematurely following hemorrhage who have a positive fFN test. [ Time Frame: measured at delivery ]
  Measure the total number of patients (participants) who delivered prematurely as a result of hemorrhage who also had a positive fFN test.

Original Secondary Outcome:

• Newborn Birth weight [ Time Frame: measured within 1-2 days after birth ]
  Newborn Birth weight measure immediately following birth.
• Maternal need for Blood Product replacement [ Time Frame: measured from the time participant is enrollment in the study until she is discharge from hospital following birth. (up to approximately 40 weeks) ]
  Maternal need for blood product replacement such as Fresh Frozen Plasma.
• Number of patients with a positive fetal fibronectin (fFN) who subsequently delivery prematurely as a result of hemorrhage with placenta previa. [ Time Frame: measured during the pregnancy ( an expected average of approximately 22 weeks) ]
  To date, fetal fibronectin (fFN) has not been studied in its ability to detect or predict premature delivery related to hemorrhage with placenta previa. As a secondary part of this study we propose determining whether this marker (fFN) of preterm delivery may be useful in pregnancies with placenta previas. From a strictly observational standpoint we will looks at the relationship between fFN markers and hemorrhage or preterm delivery.

Dates:
Date Received: September 15, 2011
Date Started: March 2012
Date Completion:
Last Updated: December 17, 2014
Last Verified: December 2014