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Oxytocin And Uterotonic Agent Use For Cesarean Delivery

This study has been completed.
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: June 27, 2017
Last verified: June 2017
Results First Received: February 24, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Uterine Atony
Hypotension
Interventions: Drug: Oxytocin Infusion
Drug: Oxytocin Bolus

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.

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 (Intramuscular).

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.

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).


Participant Flow:   Overall Study
    Standard Care Group   Protocol Group
STARTED   30   30 
COMPLETED   30   30 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.

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.

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).

Total Total of all reporting groups

Baseline Measures
   Standard Care Group   Protocol Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age, Customized 
[Units: Participants]
Count of Participants
     
Between 18 and 40 years of age   30   30   60 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      30 100.0%      30 100.0%      60 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      4  13.3%      4  13.3%      8  13.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      6  20.0%      4  13.3%      10  16.7% 
White      20  66.7%      22  73.3%      42  70.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   30   30   60 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone.   [ Time Frame: Up to 15 min from time of infant delivery ]

2.  Secondary:   Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use   [ Time Frame: Up to 15 min from time of infant delivery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lawrence Tsen, MD
Organization: Brigham and Women's Hospital
phone: 617-732-8216
e-mail: ltsen@partners.org



Responsible Party: Lawrence Ching Tsen, 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
Results First Received: February 24, 2017
Last Updated: June 27, 2017