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Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation

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.
 
ClinicalTrials.gov Identifier: NCT02083809
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : May 15, 2018
Sponsor:
Collaborators:
Society of Family Planning
University of Washington
Information provided by (Responsible Party):
Bliss Kaneshiro, University of Hawaii

Tracking Information
First Submitted Date  ICMJE March 4, 2014
First Posted Date  ICMJE March 11, 2014
Last Update Posted Date May 15, 2018
Actual Study Start Date  ICMJE October 2014
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2014)
Rate at which providers intervene to control blood loss during D&E procedures. [ Time Frame: During surgical procedure ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation
Official Title  ICMJE A Randomized Double-blinded Controlled Trial Comparing Dilation and Evacuation Outcomes With and Without Oxytocin Use
Brief Summary Currently, there is very little research to identify ways to decrease blood loss during D&E (dilation and evacuation) procedures. The objective is to determine whether routine use of intravenous oxytocin will improve bleeding outcomes at the time of D&E at 18-24-weeks gestation. To evaluate the hypothesis, investigators will perform a randomized, double-blinded, placebo-controlled trial. The patient will be followed until discharged from the postoperative care unit during which time patient satisfaction, pain score and postoperative bleeding will be assessed.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Abortion
  • Dilation and Evacuation
  • Hemorrhage
  • Blood Loss
Intervention  ICMJE
  • Drug: intravenous oxytocin
    30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)
  • Drug: Intravenous Fluids and Electrolytes
    500 ml of inert IV fluid
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    500ml saline or lactated ringer without oxytocin added
    Intervention: Drug: Intravenous Fluids and Electrolytes
  • Active Comparator: Treatment group
    Intravenous oxytocin mixed with saline or lactated ringer
    Intervention: Drug: intravenous oxytocin
Publications * Whitehouse K, Tschann M, Soon R, Davis J, Micks E, Salcedo J, Savala M, Kaneshiro B. Effects of Prophylactic Oxytocin on Bleeding Outcomes in Women Undergoing Dilation and Evacuation: A Randomized Controlled Trial. Obstet Gynecol. 2019 Mar;133(3):484-491. doi: 10.1097/AOG.0000000000003104. Erratum in: Obstet Gynecol. 2019 Jun;133(6):1287-1288.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2014)
166
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2018
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Requesting pregnancy termination
  • Intrauterine pregnancy at 18- to 24-weeks gestation
  • Gestational-age to be confirmed by ultrasound
  • Patients with fetal anomaly or intrauterine fetal demise that occurred at 18- to 24-weeks gestation
  • Willing and able to understand and sign written informed consents in English or Spanish and comply with study procedures

Exclusion Criteria:

  • Ultrasound findings suggestive of placenta accreta
  • Patients requiring preoperative misoprostol
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 14 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02083809
Other Study ID Numbers  ICMJE OxyDE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bliss Kaneshiro, University of Hawaii
Study Sponsor  ICMJE University of Hawaii
Collaborators  ICMJE
  • Society of Family Planning
  • University of Washington
Investigators  ICMJE Not Provided
PRS Account University of Hawaii
Verification Date May 2018

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