We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oxytocin And Uterotonic Agent Use For Cesarean Delivery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01549223
First Posted: March 9, 2012
Last Update Posted: June 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lawrence Ching Tsen, Brigham and Women's Hospital
March 3, 2012
March 9, 2012
February 24, 2017
June 29, 2017
June 29, 2017
April 2011
January 2012   (Final data collection date for primary outcome measure)
1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone. [ Time Frame: Up to 15 min from time of infant delivery ]
Will measure total amount of oxytocin to achieve satisfactory uterine tone, as determined by the operating obstetrician.
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 ]
Will measure total amount of oxytocin, methergine, hemebate, and cytotec to achieve satisfactory uterine tone, as determined by the operating obstetrician.
Complete list of historical versions of study NCT01549223 on ClinicalTrials.gov Archive Site
Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use [ Time Frame: Up to 15 min from time of infant delivery ]
Number of subjects experiencing hypotension, flushing, nausea, and emesis reported after administration of uterotonic agents.
Side effects associated with uterotonic drug use [ Time Frame: Up to 15 min from time of infant delivery ]
Will evaluate the incidence of hypotension, flushing, nausea, and emesis reported after administration of uterotonic agents.
Not Provided
Not Provided
 
Oxytocin And Uterotonic Agent Use For Cesarean Delivery
A Randomized Controlled Trial of Standardized Versus Conventional Oxytocin and Uterotonic Agent Use for Cesarean Delivery

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

The investigators primary hypothesis is that the proposed uterotonic drug regimen, when compared to conventional dosing regimen, during elective 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

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Uterine Atony
  • Hypotension
  • Drug: Oxytocin Infusion
    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
    • misoprostol 600 mcg buccally
  • Drug: Oxytocin Bolus
    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
    • misoprostol 600 mcg buccally
  • 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 (intramuscular) 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.

    Intervention: Drug: Oxytocin Infusion
  • 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.

    Intervention: Drug: Oxytocin Bolus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2012
January 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Conditions that predispose to uterine atony and postpartum hemorrhage
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01549223
2010-P-002284
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Plan to Share IPD: No
Lawrence Ching Tsen, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Lawrence C Tsen, MD Brigham and Women's Hospital/Harvard Medical School
Brigham and Women's Hospital
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP