Oxytocin Infusions and Blood Loss in Patients Undergoing Elective Cesarean Delivery.

Overview

Although prior dose-finding studies have investigated the optimal bolus dose of oxytocin to initiate adequate uterine tone, it is unclear what oxytocin infusion regimen is required to maintain adequate uterine tone after delivery. The study investigators aim to compare two different infusion rates of oxytocin to assess the optimal infusion regimen for reducing blood loss in women undergoing elective Cesarean delivery.

Full Title of Study: “Effects of Different Oxytocin Infusions on Blood Loss and Postpartum Hemoglobin Values in Patients Undergoing Elective Cesarean Delivery”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: September 2015

Detailed Description

Oxytocin (pitocin) is a drug commonly used in obstetric practice, and the drug effect is to increase the muscular tone of the uterus to reduce uterine bleeding after neonatal delivery. Pregnant patients undergoing elective (scheduled)Cesarean delivery routinely receive oxytocin after delivery of the baby. Post-delivery, oxytocin is commonly administered as an IV bolus and/or infusion. No previous studies have accurately assessed differences in oxytocin infusions after delivery in patients undergoing elective cesarean delivery. Thus the study aim is to investigate which infusion rate can optimally provide adequate maintenance of uterine tone during Cesarean delivery while being associated with minimal or no maternal side-effects.

Interventions

• Drug: Oxytocin Infusion
  • Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.

Arms, Groups and Cohorts

• Experimental: Oxytocin Infusion 1
  • Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.
• Active Comparator: Oxytocin Infusion 2
  • Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.

Clinical Trial Outcome Measures

Primary Measures

• Total Estimated Blood Loss
  • Time Frame: immediately at end of surgery
  • Blood loss will be measured volumetrically (based on measured volume of blood within the suction chamber) and gravimetrically (based on blood weight on blood soaked laps).

Secondary Measures

• Hemoglobin Indices After Cesarean Delivery
  • Time Frame: 24 hr after cesarean delivery
  • Study investigators will assess maternal hemoglobin levels at 24hr after cesarean delivery

Participating in This Clinical Trial

Inclusion Criteria

• Healthy pregnant patients with uncomplicated pregnancies: – ASA (American Association of Anesthesiologists) class 1 or 2 patients. – Singleton pregnancies. Exclusion Criteria:

• ASA class 3 or 4 patients. – Known drug allergy to intravenous oxytocin. – Significant medical or obstetric disease. – Known uterine abnormality. – Known placental abnormality.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Stanford University
• Provider of Information About this Clinical Study
  • Principal Investigator: Alex James Butwick, Principal Investigator – Stanford University
• Overall Official(s)
  • Alexander J Butwick, F.R.C.A., Principal Investigator, Stanford University