NCT01416454

Brief Summary

The purpose of the study is to assess potential age-related differences on coagulation profile of patients undergoing Cesarean Section, using thromboelastography (TEG). The investigators will compare coagulation data collected from the study to assess potential differences in coagulation parameters for the following age groups: (i) women less than 35 yrs (ii) women 35 yrs or older.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

1.5 years

First QC Date

August 11, 2011

Last Update Submit

March 20, 2013

Conditions

Thrombophilia

Outcome Measures

Primary Outcomes (1)

  • Thromboelastography parameters

    Thromboelastography parameters include: Reaction (r) time Clot Formation (k) time Alpha Angle Maximum Amplitude (MA) Time to maximum rate of thrombus generation (Tmax) Maximum rate of thrombus generation (MRTG) Total Thrombus generated (TTG)

    3 days

Secondary Outcomes (1)

  • laboratory coagulation parameters

    3 days

Study Arms (2)

Elective Cesarean delivery, age <35 yrs

Women undergoing elective cesarean delivery with a spinal anesthetic who are less than 35 y of age (at the time of delivery).

Elective Cesarean delivery, age =>35 yrs

Women undergoing elective Cesarean delivery with a spinal anesthetic who are =\> 35 yrs of age (at the time of delivery).

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Our study population will be obstetric patients undergoing delivery on the labor and delivery unit at Lucile Packard Children's Hospital (LPCH).

You may qualify if:

  • All obstetric patients with singleton pregnancies admitted to the labor and delivery unit at LPCH who undergo elective Cesarean delivery with neuraxial anesthesia.
  • We will enroll only healthy patients with singleton pregnancies and whose pregnancy is not result of in vitro fertilization.

You may not qualify if:

  • Patients with underlying coagulation disorders.
  • Patients with thrombocytopenia.
  • Patients with pregnancy-induced hypertension, pre-eclampsia.
  • Patients requiring the following medications prior to surgery: non-steroidal anti-inflammatories, aspirin, anticoagulants.
  • Patients requiring non-elective Cesarean delivery.
  • Patients with significant obstetric or medical disease.
  • No patients \<18 years of age will be recruited.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (7)

  • James AH. Venous thromboembolism in pregnancy. Arterioscler Thromb Vasc Biol. 2009 Mar;29(3):326-31. doi: 10.1161/ATVBAHA.109.184127.

    PMID: 19228606BACKGROUND

  • Bates SM, Greer IA, Pabinger I, Sofaer S, Hirsh J. Venous thromboembolism, thrombophilia, antithrombotic therapy, and pregnancy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):844S-886S. doi: 10.1378/chest.08-0761.

    PMID: 18574280BACKGROUND

  • Morris JM, Algert CS, Roberts CL. Incidence and risk factors for pulmonary embolism in the postpartum period. J Thromb Haemost. 2010 May;8(5):998-1003. doi: 10.1111/j.1538-7836.2010.03794.x. Epub 2010 Feb 1.

    PMID: 20128859BACKGROUND

  • Sharma SK, Philip J, Wiley J. Thromboelastographic changes in healthy parturients and postpartum women. Anesth Analg. 1997 Jul;85(1):94-8. doi: 10.1097/00000539-199707000-00017.

    PMID: 9212129BACKGROUND

  • Saha P, Stott D, Atalla R. Haemostatic changes in the puerperium '6 weeks postpartum' (HIP Study) - implication for maternal thromboembolism. BJOG. 2009 Nov;116(12):1602-12. doi: 10.1111/j.1471-0528.2009.02295.x. Epub 2009 Aug 14.

    PMID: 19681851BACKGROUND

  • Ng KF. Changes in thrombelastograph variables associated with aging. Anesth Analg. 2004 Aug;99(2):449-54, table of contents. doi: 10.1213/01.ANE.0000133140.75831.1E.

    PMID: 15271723BACKGROUND

  • Butwick A, Gutierrez MC, Hilton G. The impact of advanced maternal age on peripartum thromboelastographic coagulation profiles: a prospective observational exploratory study. Can J Anaesth. 2015 May;62(5):504-12. doi: 10.1007/s12630-014-0300-0. Epub 2014 Dec 31.

    PMID: 25549988DERIVED

MeSH Terms

Conditions

Thrombophilia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Alex James Butwick

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2011

First Posted

August 15, 2011

Study Start

October 1, 2010

Primary Completion

April 1, 2012

Study Completion

November 1, 2012

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations

US(1)