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Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation

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ClinicalTrials.gov Identifier: NCT02083809
Recruitment Status : Completed
First Posted : March 11, 2014
Results First Posted : November 27, 2020
Last Update Posted : November 27, 2020
Sponsor:
Collaborators:
Society of Family Planning
University of Washington
Information provided by (Responsible Party):
Bliss Kaneshiro, University of Hawaii

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Abortion
Dilation and Evacuation
Hemorrhage
Blood Loss
Interventions Drug: intravenous oxytocin
Drug: Intravenous Fluids and Electrolytes
Enrollment 166
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Treatment Group
Hide Arm/Group Description

500ml saline or lactated ringer without oxytocin added

Intravenous Fluids and Electrolytes: 500 ml of inert IV fluid

Intravenous oxytocin mixed with saline or lactated ringer

intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)

Period Title: Overall Study
Started 82 84
Completed 78 82
Not Completed 4 2
Arm/Group Title Placebo Treatment Group Total
Hide Arm/Group Description

500ml saline or lactated ringer without oxytocin added

Intravenous Fluids and Electrolytes: 500 ml of inert IV fluid

Intravenous oxytocin mixed with saline or lactated ringer

intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)

Total of all reporting groups
Overall Number of Baseline Participants 78 82 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Age
Number Analyzed 78 participants 82 participants 160 participants
27.2  (7.2) 25.4  (7) 26.3  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 82 participants 160 participants
Female
78
 100.0%
82
 100.0%
160
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 82 participants 160 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
14
  17.9%
13
  15.9%
27
  16.9%
Native Hawaiian or Other Pacific Islander
23
  29.5%
27
  32.9%
50
  31.3%
Black or African American
5
   6.4%
10
  12.2%
15
   9.4%
White
36
  46.2%
32
  39.0%
68
  42.5%
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%
1.Primary Outcome
Title Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures.
Hide Description [Not Specified]
Time Frame During surgical procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Treatment Group
Hide Arm/Group Description:

500ml saline or lactated ringer without oxytocin added

Intravenous Fluids and Electrolytes: 500 ml of inert IV fluid

Intravenous oxytocin mixed with saline or lactated ringer

intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)

Overall Number of Participants Analyzed 78 82
Measure Type: Count of Participants
Unit of Measure: Participants
13
  16.7%
6
   7.3%
Time Frame 1 day
Adverse Event Reporting Description laceration of the cervix requiring repair with suturing
 
Arm/Group Title Placebo Treatment Group
Hide Arm/Group Description

500ml saline or lactated ringer without oxytocin added

Intravenous Fluids and Electrolytes: 500 ml of inert IV fluid

Intravenous oxytocin mixed with saline or lactated ringer

intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)

All-Cause Mortality
Placebo Treatment Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)      0/82 (0.00%)    
Hide Serious Adverse Events
Placebo Treatment Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/78 (1.28%)      1/82 (1.22%)    
Reproductive system and breast disorders     
cervical laceration   1/78 (1.28%)  1 1/82 (1.22%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Treatment Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/78 (0.00%)      0/82 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr.
Organization: University of Hawaii
Phone: 8082036500
EMail: whrc@ucera.org
Layout table for additonal information
Responsible Party: Bliss Kaneshiro, University of Hawaii
ClinicalTrials.gov Identifier: NCT02083809    
Other Study ID Numbers: OxyDE
First Submitted: March 4, 2014
First Posted: March 11, 2014
Results First Submitted: October 2, 2020
Results First Posted: November 27, 2020
Last Update Posted: November 27, 2020