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Trial record 33 of 618 for:    Hemorrhage AND postpartum

Oxytocin Regimen to Prevent Atony and Postpartum Hemorrhage During Vaginal Delivery: 3-arm RCT

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ClinicalTrials.gov Identifier: NCT00790062
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : January 30, 2014
Last Update Posted : April 8, 2016
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Alan Tita, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Uterine Atony
Postpartum Hemorrhage
Intervention Drug: Oxytocin
Enrollment 1798
Recruitment Details There were 1,798 women randomized.
Pre-assignment Details At planned interim review (n=1,201), enrollment in the 40-unit group was stopped for futility and enrollment continued in the other groups.
Arm/Group Title Oxytocin 10 Units/500cc Oxytocin 40 Units/500cc Oxytocin 80U/500cc
Hide Arm/Group Description [Not Specified] Per DSMB recommendations, this intermediate arm was stopped Jan 2010. [Not Specified]
Period Title: Overall Study
Started 659 481 658
Completed 659 481 658
Not Completed 0 0 0
Arm/Group Title Oxytocin 10 Units/500cc Oxytocin 40 Units/500cc Oxytocin 80U/500cc Total
Hide Arm/Group Description [Not Specified] Per DSMB recommendations, this intermediate arm was stopped Jan 2010. [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 659 481 658 1798
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age (years) Number Analyzed 659 participants 481 participants 658 participants 1798 participants
23.9  (5.4) 23.9  (5.1) 24.4  (5.5) 24.2  (5.4)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Female Number Analyzed 659 participants 481 participants 658 participants 1798 participants
659 481 658 1798
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 659 participants 481 participants 658 participants 1798 participants
Caucasian 143 97 156 396
African American 404 278 379 1061
Hispanic 106 101 120 327
Other (not specified) 6 5 3 14
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 659 participants 481 participants 658 participants 1798 participants
659 481 658 1798
1.Primary Outcome
Title Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment
Hide Description the number of subjects with any treatment of uterineatony or hemorrhage.
Time Frame baseline to discharge (2 - 3 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin 10 Units/500cc Oxytocin 40 Units/500cc Oxytocin 80U/500cc
Hide Arm/Group Description:
1 dose only for prophylaxsis given over 1 hour

Per DSMB recommendations, this intermediate arm was stopped Jan 2010.

1 dose only for prophylaxsis given over 1 hour

1 dose only for prophylaxsis given over 1 hour
Overall Number of Participants Analyzed 659 481 658
Measure Type: Number
Unit of Measure: Participants
45 31 42
2.Primary Outcome
Title Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage
Hide Description In a secondary data analysis, a parsimonious set of independent risk factors for atony or postpartum hemorrhage was established: White, Hispanic, or Other (non-Black of African American) race/ethnicity, preeclampsia, or chorioamnionitus.
Time Frame Initial hospital discharge (2-3 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin 10 Units/500cc Oxytocin 40 Units/500cc Oxytocin 80U/500cc
Hide Arm/Group Description:

1 dose only for prophylaxis given over 1 hour

Oxytocin: See arms

One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.

Oxytocin: See arms

1 dose only given over 1 hour

Oxytocin: See arms

Overall Number of Participants Analyzed 659 481 658
Measure Type: Number
Unit of Measure: participants
351 255 333
3.Primary Outcome
Title Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors
Hide Description The frequency of the primary study outcome is examined in a subgroup of 939 women with risk factors for atony or postpartum hemorrhage. These risk factors are identified as White, Hispanic, or Other (non-Black or African American) race/ethnicity, chorioamnionitis, and preeclampsia.
Time Frame baseline to discharge (2-3 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin 10 Units/500cc Oxytocin 40 Units/500cc Oxytocin 80U/500cc
Hide Arm/Group Description:

1 dose only for prophylaxis given over 1 hour

Oxytocin: See arms

One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.

Oxytocin: See arms

1 dose only given over 1 hour

Oxytocin: See arms

Overall Number of Participants Analyzed 351 225 333
Measure Type: Number
Unit of Measure: participants
37 22 28
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxytocin 10 Units/500cc, Oxytocin 40 Units/500cc, Oxytocin 80U/500cc
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.670
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.63 to 1.59
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Pre- to Post-delivery Hematocrit (%)
Hide Description change in hematocrit from admission for delivery (baseline) to post-delivery (4 hours-1day postpartum depending on time of delivery)
Time Frame During delivery hospitalization: Admission hematocrit - post-delivery hematocrit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin 10 Units/500cc Over 1 Hour Oxytocin 40 Units/500cc Over 1 Hour Oxytocin 80U/500cc Over 1 Hour
Hide Arm/Group Description:
[Not Specified]
Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
[Not Specified]
Overall Number of Participants Analyzed 659 481 658
Median (Inter-Quartile Range)
Unit of Measure: hematocrit difference (%)
4
(1 to 8)
4
(1 to 8)
4
(1 to 7)
5.Secondary Outcome
Title Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome
Hide Description the number of individuals with each of the component treatments or individual outcomes in the primary composite.
Time Frame prior to discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin 10 Units/500cc Oxytocin 40 Units/500cc Oxytocin 80U/500cc
Hide Arm/Group Description:
[Not Specified]
Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
[Not Specified]
Overall Number of Participants Analyzed 659 481 658
Measure Type: Number
Unit of Measure: Participants
Any Uterotonic 45 30 40
Blood Transfusion 7 4 5
Surgical 0 0 1
Other-Tamponade 0 1 0
Other-Arterial embolization 1 0 1
6.Secondary Outcome
Title Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc)
Time Frame Initial hospital discharge (2-3 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin 10 Units/500cc Oxytocin 40 Units/500cc Oxytocin 80U/500cc
Hide Arm/Group Description:
[Not Specified]
Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
[Not Specified]
Overall Number of Participants Analyzed 659 481 658
Measure Type: Number
Unit of Measure: Participants
38 24 24
7.Secondary Outcome
Title Number of Subjects With Hospital Stays Greater Than 4 Days
Hide Description Number of individuals with prolonged hospitalization defined as 4 days or more prior to initial hospital discharge
Time Frame Initial hospital discharge (2 days or more)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin 10 Units/500cc Oxytocin 40 Units/500cc Oxytocin 80U/500cc
Hide Arm/Group Description:
[Not Specified]
Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
[Not Specified]
Overall Number of Participants Analyzed 659 481 658
Measure Type: Number
Unit of Measure: Participants
116 95 109
8.Secondary Outcome
Title Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus
Hide Description number of individuals with hypotension leading to administration of a fluid bolus or vasopressor agent (medication given to raise the blood pressure)
Time Frame Initial hospital discharge (2-3 days or more)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin 10 Units/500cc Oxytocin 40 Units/500cc Oxytocin 80U/500cc
Hide Arm/Group Description:
[Not Specified]
Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
[Not Specified]
Overall Number of Participants Analyzed 659 481 658
Measure Type: Number
Unit of Measure: Participants
Pressor agent (medication given to increase BP) 85 56 95
Fluid bolus 82 51 87
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxytocin 10 Units/500cc Oxytocin 40 Units/500cc Oxytocin 80U/500cc
Hide Arm/Group Description [Not Specified] Per DSMB recommendations, this intermediate arm was stopped Jan 2010. [Not Specified]
All-Cause Mortality
Oxytocin 10 Units/500cc Oxytocin 40 Units/500cc Oxytocin 80U/500cc
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oxytocin 10 Units/500cc Oxytocin 40 Units/500cc Oxytocin 80U/500cc
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/659 (0.00%)   0/481 (0.00%)   0/658 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Oxytocin 10 Units/500cc Oxytocin 40 Units/500cc Oxytocin 80U/500cc
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/659 (0.00%)   0/481 (0.00%)   0/658 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Alan T. N. Tita, MD
Organization: University of Alabama at Birmingham
Phone: (205) 934-9616
EMail: atit@uab.edu
Responsible Party: Alan Tita, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00790062     History of Changes
Other Study ID Numbers: F070910007
5K12HD001258-09 ( U.S. NIH Grant/Contract )
First Submitted: November 12, 2008
First Posted: November 13, 2008
Results First Submitted: May 30, 2012
Results First Posted: January 30, 2014
Last Update Posted: April 8, 2016