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

Postpartum Hemorrhage Clinical Trial

Official title:

Effects of Different Oxytocin Infusions on Blood Loss and Postpartum Hemoglobin Values in Patients Undergoing Elective Cesarean Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01932060
• Other study ID #: 28015
• Status: Recruiting
• Phase: Phase 3
• First received: August 21, 2013
• Last updated: August 28, 2013
• Start date: August 2013
• Est. completion date: September 2014

Study information

• Verified date: August 2013
• Source: Stanford University
• Contact: Alexander J Butwick, F.R.C.A.
• Phone: (650) 736-8513
• Email: ajbut[@]stanford.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital, Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total estimated blood loss	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).	Measurements will occur at the of the surgical period	No
Secondary	hemoglobin indices after cesarean delivery	Study investigators will assess maternal hemoglobin levels at 24hr and 72 hr after cesarean delivery	24 hr and 72 h after cesarean delivery	No
Secondary	Non-invasive Hb levels	Study investigators will collect non-invasive maternal hemoglobin (SpHb) levels during the cesarean delivery and at 24 hr intervals until day 4 post cesarean delivery.	Measurements will be taken continuously during the perioperative period, at at specific time points after cesarean delivery: 24hr, 48hr, 72hr post-cesarean delivery	No
Secondary	Thromboelastographic indices	Study investigators will measure thromboelastographic indices prior to cesarean delivery on the day of surgery and post-cesarean delivery in the post-anesthesia care unit.	During the pre-operative period on the day of surgery at within 1hr of completion of surgery	No
Secondary	Oxytocin related side-effects	study investigators will assess oxytocin-related side-effects including maternal tachycardia, hypotension, nausea, vomiting, flushing, headache, chest pain and other idiosyncratic drug-reactions.	During the perioperative period and upto 90 mins after delivery of the fetus	No