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Outcomes After the Implementation of a New Oxytocin Protocol

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ClinicalTrials.gov Identifier: NCT02722356
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Stacy Muir, C.R.Darnall Army Medical Center

Brief Summary:
The proposed study is a prospective, randomized, active control, open label study. One hundred sixty subjects undergoing elective cesarean section will be randomly assigned to one of two groups (n = 80 per group): the oxytocin protocol group or the standard practice group. The oxytocin protocol group will receive oxytocin boluses along with a regulated infusion according to a stepwise algorithm following delivery of the placenta. The standard practice group will receive oxytocin via a free flowing ("wide-open") infusion with a concentration of 30 IU per 500 mL of 0.9% normal saline following the delivery of the placenta. Primary outcomes include uterine tone (adequate or inadequate) as assessed by the surgeon, amount of time required to establish adequate uterine tone following the delivery of the infant, total dose of oxytocin required to establish adequate uterine tone, and total calculated blood loss based on pre-operative and post-operative hematocrit concentrations. Secondary outcomes include total estimated blood loss as agreed upon by the surgeon and the anesthesia provider, use of additional uterotonic drugs, mean arterial pressure, and incidence of oxytocin side effects (nausea, chest tightness/pain, and ST-segment changes).

Condition or disease Intervention/treatment Phase
Complications; Cesarean Section Adverse Reaction to Oxytocin Drug: Oxytocin Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcomes After Implementation of a New Oxytocin Protocol for the Prevention of Postpartum Hemorrhage in Non-emergent Cesarean Sections
Actual Study Start Date : April 2016
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin
Oxytocin administered according to proposed protocol
Drug: Oxytocin
Oxytocin administered per oxytocin group or standard practice group (see above)
Other Name: Pitocin

Active Comparator: Standard Practice
Oxytocin administered according to standard practice at facility
Drug: Oxytocin
Oxytocin administered per oxytocin group or standard practice group (see above)
Other Name: Pitocin




Primary Outcome Measures :
  1. Change in uterine tone [ Time Frame: 3, 6, and 9 minutes after first dose of oxytocin ]
    Uterine tone deemed adequate or inadequate as assessed by the surgeon

  2. Time to adequate uterine tone [ Time Frame: From the delivery of the infant to the completion of the cesarean section ]
    Amount of time (minutes) required to establish adequate uterine tone following the delivery of the infant

  3. Oxytocin dose [ Time Frame: Duration of cesarean section ]
    Total dose of oxytocin required to establish adequate uterine tone

  4. Total calculated blood loss [ Time Frame: 24 hours pre-op to 24 hours post-op ]
    Total calculated blood loss based on pre-operative and post-operative hematocrit concentrations


Secondary Outcome Measures :
  1. Total estimated blood loss [ Time Frame: Duration of cesarean section ]
    Total estimated blood loss as agreed upon by the surgeon and the anesthesia provider

  2. Additional uterotonic drugs (in addition to oxytocin) required to establish adequate uterine tone: yes/no [ Time Frame: Duration of cesarean section ]
  3. Oxytocin side effects [ Time Frame: Duration of cesarean section ]
    incidence of oxytocin side effects (nausea, chest tightness/pain, and ST-segment changes)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women with American Society of Anesthesiologists (ASA) physical status II (subjects with ASA physical status III based solely on a body mass index [BMI] ≥ 40 will be included in the study)
  • Over 18 years of age
  • Undergoing an elective cesarean section under neuraxial anesthesia

Exclusion Criteria:

  • Maternal or obstetrician refusal
  • Multiple gestation
  • Ruptured membranes
  • Abnormal placentation
  • Preexisting coagulopathy
  • Macrosomia
  • Chorioamnionitis
  • Diabetes mellitus (preexisting, not gestational)
  • Uterine fibroids
  • Contraindication to neuraxial anesthesia
  • Previous allergic reaction to synthetic oxytocin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722356


Sponsors and Collaborators
C.R.Darnall Army Medical Center
Investigators
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Study Chair: John Murphy, DNP Carl R. Darnall Army Medical Center, U.S. Army Graduate Program in Anesthesia Nursing

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Responsible Party: Stacy Muir, CPT, Student Registered Nurse Anesthetist, C.R.Darnall Army Medical Center
ClinicalTrials.gov Identifier: NCT02722356     History of Changes
Other Study ID Numbers: 417969-1
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs