Coagulation Factor Changes Associated With Postpartum Hysterectomies

NCT00456547 | Completed Results

• 1 other identifier: 0524-020
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine components of the coagulation system in women undergoing postpartum hysterectomy and to compare laboratory parameters of coagulation in these women to women at increased risk for a postpartum hysterectomy, but who do not have postpartum hemorrhage and a postpartum hysterectomy. During normal pregnancy, the hemostatic balance tips toward hypercoagulation. Non-obstetric surgical blood loss is associated with increased coagulation activity. We have observed that women undergoing a postpartum hysterectomy become hypocoagulable secondary to a consumptive coagulopathy and/or excessive fibrinolysis. This coagulopathy may lead to the administration of multiple blood products. Worldwide, postpartum hemorrhage is a leading cause of maternal death. Plasma levels of tissue plasminogen activator, urokinase plasminogen activator and their inhibitors increase during pregnancy. During labor and delivery activation of coagulation occurs with consumption of platelets, coagulation factors and inhibitors. Obstetric complications during delivery can excessively activate the coagulation system and disseminated intravascular coagulation may ensue. Current treatment for postpartum coagulopathy is non-specific and primarily consists of replacing blood components. If specific causes or markers of abnormal coagulation can be identified in women at risk, then it might be possible to target (with specific medications) specific abnormalities early in the process and decrease hemorrhage and the need for blood transfusions.

Conditions

Obstetric Labor Complications; Hemorrhage; Complications; Cesarean Section

Keywords

Cesarean hysterectomy; Postpartum hemorrhage; Coagulation

Outcome Measures

Primary Outcomes (1)

• Fibrinogen Level at 2 Hours After Delivery

  Fibrinogen level decrease is a marker of consumptive coagulation which is is a pathological activation of coagulation (blood clotting) mechanisms that happens in response to a variety of diseases or stimulus. We hypothesized that women with excessive bleeding following delivery who require a hysterectomy are more likely to exhibit lower levels of fibrinogen and a consumptive coagulopathy than women following cesarean delivery who do not bleed.

  2 hours after delivery

Secondary Outcomes (3)

• Platelet Counts at 2 Hours After Delivery

  2 hours after delivery

• Plasminogen Levels 2 Hours After Delivery

  2 hours after delivery

• Antithrombin III Levels at 2 Hours Post Delivery

  2 hours after delivery

Study Arms (2)

Postpartum hysterectomy

Women that require postpartum hysterectomy for post-delivery bleeding.

Procedure: Blood Draw

Cesarean delivery case controls

Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy

Procedure: Blood Draw

Interventions

Blood Draw PROCEDURE

Blood was obtained for coagulation studies at 2 hours following hysterectomy or cesarean delivery.

Also known as: postpartum coagulation disorder

Cesarean delivery case controls; Postpartum hysterectomy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant Women

You may qualify if:

• All women scheduled for a Cesarean-hysterectomy will be asked to enroll in the study, as well as the women with the following diagnoses, that puts them at increased risk for Cesarean hysterectomy: placenta previa, placenta accreta, vaginal trial of labor after previous Cesarean delivery.

You may not qualify if:

• Anyone who does not fit the above criteria.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

• Tuman KJ, Spiess BD, McCarthy RJ, Ivankovich AD. Effects of progressive blood loss on coagulation as measured by thrombelastography. Anesth Analg. 1987 Sep;66(9):856-63.

  PMID: 3619091 BACKGROUND

• Hellgren M. Hemostasis during normal pregnancy and puerperium. Semin Thromb Hemost. 2003 Apr;29(2):125-30. doi: 10.1055/s-2003-38897.

  PMID: 12709915 BACKGROUND

• Lanir N, Aharon A, Brenner B. Procoagulant and anticoagulant mechanisms in human placenta. Semin Thromb Hemost. 2003 Apr;29(2):175-84. doi: 10.1055/s-2003-38833.

  PMID: 12709921 BACKGROUND

• Saftlas AF, Olson DR, Atrash HK, Rochat R, Rowley D. National trends in the incidence of abruptio placentae, 1979-1987. Obstet Gynecol. 1991 Dec;78(6):1081-6.

  PMID: 1945212 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor Complications; Hemorrhage; Postpartum Hemorrhage; Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Puerperal Disorders; Uterine Hemorrhage; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Robert J McCarthy, Pharm D
• Organization: Northwestern University Feinberg School of Medicine

r-mccarthy@northwestern.edu

312-926-9015

Study Officials

• Cynthia A Wong, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: April 3, 2007
• First Posted: April 5, 2007
• Study Start: December 1, 2003
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: April 14, 2014
• Results First Posted: February 20, 2012

Record last verified: 2014-03

Locations

US (1)