The Clotting Effects of Pentastarch and Normal Saline in Obstetric Patients

NCT00474162 | Completed

• 1 other identifier: H06-03374
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Pregnant women are more likely to form clots than non-pregnant women as pregnancy increases the clotting factors present in the blood. This helps to prevent excess bleeding (hemorrhage) at the time of delivery. Hemorrhage occurs in 5-15% of pregnancies throughout the world, even when delivery is by cesarean section. When hemorrhage occurs the anesthesiologist will normally administer fluids into the woman's vein (intravenously) rapidly to replace the blood that the woman has lost. Two types of fluids are commonly used. One is a salt water solution (saline) and the other is a starch water solution (pentastarch). Use of either or both of these solutions is common during hemorrhage. These same solutions (salt water solution and starch solution) are used at BC Women's Hospital during spinal anesthesia to prevent and treat low blood pressure (a common side effect of spinal anesthesia). This is standard practice whether you are in this study or not. You may also be given, depending on the anesthesiologist's preference, a drug (vasopressor) that causes the blood vessels to become narrow (constrict) to prevent or treat the low blood pressure. Whether you agree to be part of the study or not, your anesthesiologist will be watching your blood pressure closely throughout your operation and if your blood pressure becomes low he/she will treat it as is normally done. Low blood pressure will also occur during hemorrhage. It is therefore important that we determine whether the starch solution, which is more effective than the salt solution in preventing low blood pressure during spinal anesthesia, does or does not affect clotting. Research in non-pregnant adults (male and female) has found that laboratory tests of blood clotting change with these solutions. For saline the evidence in some studies suggests that the blood may clot better than normal while other studies suggest the opposite (does not clot as well). In pregnant and non-pregnant adults the blood does not clot as well with certain starch solutions. The starch solution used at BC Women's Hospital is called pentastarch and no research has looked at its effect on clotting in pregnant women. In non-pregnant adults pentastarch has less effect on clotting than other starch solutions. The purpose of the study is to see how pentastarch (starch solution) and normal saline (water with salt in it) given at the time of spinal anesthesia for elective cesarean section affect the ability of pregnant woman's blood to clot.

Conditions

Elective Cesarean Section

Keywords

Cesarean section; coagulation changes

Outcome Measures

Primary Outcomes (1)

• TEG (clotting) parameters at baseline, 5 minutes & 90 minutes post-infusion

  During surgery

Secondary Outcomes (1)

• Changes in INR, APTT and estimated blood loss

  During surgery

Interventions

Pentaspan® DRUG

15 ml/kg of starch solution, approximately 1 litre

Normal Saline DRUG

15 ml/kg of either saline solution, approximately 1 litre

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 19 years or over
• having an elective cesarean section under spinal anesthesia
• at least 36 weeks gestation
• in general good health

You may not qualify if:

• blood does not clot normally
• taking heparin or Aspirin® (acetylsalicylic acid) within 7 days of surgery
• high blood pressure
• expecting twins
• any heart abnormality (including heart failure)
• kidney or liver disease
• known allergy to hydroxyethylstarch, corn, starch or any drugs
• insulin dependent diabetes
• aged less than 19 years
• do not understand English
• having emergency surgery

Sponsors & Collaborators

• University of British Columbia: lead
• Children's & Women's Health Centre of British Columbia: collaborator

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Interventions

Hydroxyethyl Starch Derivatives; Saline Solution

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Joanne Douglas, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Jason Ford, MD

  University of British Columbia

  STUDY DIRECTOR

• Roanne Preston, MD

  University of British Columbia

  STUDY DIRECTOR

• Rhona Siegmeth, MBChB, BSc, FRCA

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 16, 2007
• Study Start: May 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: February 21, 2008

Record last verified: 2008-02

Locations

CA (1)