The Use of Thromboelastometry (ROTEM) to Evaluate the Changes in Coagulation With Two Different Doses of Oxytocin Following Cesarean Delivery

Duke University

Status: Withdrawn

Conditions: Coagulation Changes With Oxytocin

Treatments: Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT02063568

Pro00051122

Details and patient eligibility

About

The purpose of this study is to evaluate the differences in blood clotting seen in healthy patients given two different doses of oxytocin following cesarean delivery. The secondary objectives are to evaluate changes in blood pressure, rates of nausea and vomiting, and differences in blood loss with the two separate doses of oxytocin.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English speaking
• Age > or = 18 yrs
• Non-laboring women
• cesarean delivery under spinal anesthesia with pfannenstiel incision
• ASA I-III

Exclusion criteria

• Height <5'0"
• Allergy to phenylephrine
• Severe cardiac disease in pregnancy with marked functional limitations
• Women receiving NSAIDS, aspirin or other anticoagulants
• Subject enrollment in another study involving a study medication within 30 days of cesarean delivery
• Other physical or psychiatric condition which may impair the ability to cooperate with study data collection

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Low dose oxytocin infusion

Active Comparator group

Description:

oxytocin will be administered as an intravenous infusion at a rate of 0.33 units/min starting after fetal delivery upon umbilical cord clamping and continuing for a total of 30 minutes

Treatment:

Drug: Oxytocin

High dose oxytocin infusion

Active Comparator group

Description:

oxytocin will be administered as an intravenous infusion at a rate of 1.33 units/min starting after fetal delivery upon umbilical cord clamping and continuing for a total of 30 minutes

Treatment:

Drug: Oxytocin