Clinical Trial: The Use of Fetal Fibronectin to Predict Delivery Due to Abruptio Placenta

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: The Use of Fetal Fibronectin (fFN) in Predicting Preterm Delivery Due to Abruptio Placenta in Patients With Minor Maternal Trauma.

Brief Summary: The purpose of this study is to determine if the presence of fetal fibronectin in the cervicovaginal secretions of pregnant patients with minor maternal trauma predicts impending preterm delivery due to abruptio placenta.

Detailed Summary:

Optimal care of the pregnant trauma patient requires prompt and efficient care by a multidisciplinary team to evaluate both maternal and fetal status. Approximately 7% of pregnancies are complicated by trauma and traumatic injury remains the leading cause of non-obstetric maternal death.1-3 In the case of major or life-threatening trauma in pregnancy, assessment and stabilization of maternal cardiovascular and respiratory status is paramount and management is generally dictated by standard adult advanced cardiovascular support algorithms. In contrast, the evaluation and management of minor trauma in pregnancy is variable and often provider dependent.4-7 Regardless of the clinical and laboratory evaluation performed, the universal goal is to prevent maternal injury or death and optimize pregnancy outcomes.

Maternal trauma has been associated with adverse pregnancy outcome, including preterm labor, abruptio placenta, uterine rupture and fetal death.8, 9 Traditional trauma scoring systems correlate well with the severity of maternal injury and are useful in triaging the mother; however, these scoring systems have not been predictive of adverse pregnancy outcome.10,11 Major or life-threatening maternal trauma, which includes maternal shock, head injury resulting in coma, and emergency laparotomy for maternal indications is associated with a 40-50% fetal loss rate as compared to 1-5% in pregnant women after minor trauma. The risk of preterm labor after maternal trauma is increased 2-fold and the prevalence of abruptio placenta after minor blunt abdominal trauma is reported at 8%. 3,6-9,12

Upon initial evaluation in the obstetrical triage setting, the examination of maternal trauma patients is focused on detection of impending labor or abruptio placenta. This evaluation includes detailed history of the accident, physical examina
Sponsor: Winthrop University Hospital

Current Primary Outcome: Delivery within 2 weeks of the trauma event [ Time Frame: 2 weeks ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Winthrop University Hospital

Dates:
Date Received: January 14, 2011
Date Started: October 2009
Date Completion:
Last Updated: January 9, 2015
Last Verified: January 2015