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Oxytocin And Uterotonic Agent Use For Cesarean Delivery

This study is currently recruiting participants.
Verified February 2013 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Lawrence Ching Tsen, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01549223
First received: March 3, 2012
Last updated: February 3, 2013
Last verified: February 2013
History of Changes
  Purpose

The central objective of this study will be to evaluate a standardized, evidence-based regimen versus a conventional regimen for uterotonic drug dosing during cesarean delivery

The investigators primary hypothesis is that the proposed uterotonic drug regimen, when compared to conventional dosing regimen, during cesarean delivery will:

1. Reduce the overall amount of oxytocin and other uterotonic agents used to obtain satisfactory uterine tone.

Secondary outcomes to be evaluated will be:

  1. Reduce the side effects associated with uterotonic drug use
  2. Reduce the time to establishment and maintenance of adequate uterine tone

Condition Intervention Phase
Uterine Atony
Hypotension
 Drug: Oxytocin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Standardized Versus Conventional Oxytocin and Uterotonic Agent Use for Cesarean Delivery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 1. Amount of oxytocin and other uterotonic agents used to obtain satisfactory uterine tone. [ Time Frame: Up to 15 min from time of infant delivery ] [ Designated as safety issue: No ]
    Will measure total amount of oxytocin, methergine, hemebate, and cytotec to achieve satisfactory uterine tone, as determined by the operating obstetrician.


Secondary Outcome Measures:
  • Side effects associated with uterotonic drug use [ Time Frame: Up to 15 min from time of infant delivery ] [ Designated as safety issue: No ]
    Will evaluate the incidence of hypotension, flushing, nausea, and emesis reported after administration of uterotonic agents.


Estimated Enrollment: 120
Study Start Date: April 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Care Group

"Standard Care Group" (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion "oxytocin". If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.

If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.

 Drug: Oxytocin
500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.
Other Names:
  • methylergonovine maleate (methergine) 0.2 mg IM
  • carboprost tromethamine (hemabate) 0.25 mg IM
  • misprostol 600 mcg buccally
Active Comparator: Protocol Group

"Protocol Group" will receive 3 mL syringes marked "study solution-oxytocin" which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).

If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked "study solution-9 min", containing methylergonovine maleate (methergine) 0.2mg, will be given IM.

If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked "study solution-12 min", containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.

If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.

 Drug: Oxytocin
3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
Other Names:
  • methylergonovine maleate (methergine) 0.2 mg IM
  • carboprost tromethamine (hemabate) 0.25 mg IM
  • misprostol 600 mcg buccally

Detailed Description:

The current guidelines for the administration of oxytocin during cesarean delivery are diverse, empiric, and vague. A stepwise, standardized, checklist driven algorithm for the use of oxytocin and other uterotonic agents during cesarean delivery is needed to guide practitioners in a clear and concise manner. This algorithm should encompass laboring and non-laboring women, as well as prophylactic and therapeutic uses of oxytocin and other uterotonic agents.

More specifically, the investigators believe that the following points should be incorporated into a protocol: 1) oxytocin should be used in initial doses of less than 5 IU; 2) oxytocin should not be administered as a rapid IV bolus; 3) an initial rapid infusion of oxytocin should be followed by a maintenance infusion; 4) higher initial and infusion doses of oxytocin offer no clinical benefit and should be avoided; and 5) if it appears that oxytocin is not producing effective uterine contractions, other uterotonic drugs acting via different pathways should be considered in a standardized way.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) I or II health status
  • Age between 18 and 50 yrs
  • Singleton pregnancies in vertex position
  • Elective (with or without prior labor) cesarean delivery with a planned lower uterine (pfannenstiel) incision

Exclusion Criteria:

  • Conditions that predispose to uterine atony and postpartum hemorrhage
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549223

Contacts
Contact: Lawrence C Tsen, MD 617-732-8216 ltsen@zeus.bwh.harvard.edu

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lawrence C Tsen, MD     617-732-8216     ltsen@zeus.bwh.harvard.edu    
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Lawrence C Tsen, MD Brigham and Women's Hospital/Harvard Medical School
  More Information

No publications provided

Responsible Party: Lawrence Ching Tsen, Vice Chair, Faculty Development and Education; Associate Professor, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01549223     History of Changes
Other Study ID Numbers: 2010-P-002284
Study First Received: March 3, 2012
Last Updated: February 3, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Uterine Atony
Hypotension
Cesarean Delivery
 Hemorrhage
Phenylephrine
Ephedrine

Additional relevant MeSH terms:
Hypotension
Uterine Inertia
Vascular Diseases
Cardiovascular Diseases
Dystocia
Obstetric Labor Complications
Pregnancy Complications
Carboprost
Carboprost tromethamine
Methylergonovine
Oxytocin
 Maleic acid
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Oxytocics
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013