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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
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 Description
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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.

Condition or disease Intervention/treatment Phase
Abortion Dilation and Evacuation Hemorrhage Blood Loss Drug: intravenous oxytocin Drug: Intravenous Fluids and Electrolytes Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-blinded Controlled Trial Comparing Dilation and Evacuation Outcomes With and Without Oxytocin Use
Actual Study Start Date : October 2014
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Oxytocin

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
500ml saline or lactated ringer without oxytocin added
 Drug: Intravenous Fluids and Electrolytes
500 ml of inert IV fluid
Active Comparator: Treatment group
Intravenous oxytocin mixed with saline or lactated ringer
 Drug: intravenous oxytocin
30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)


Outcome Measures
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Primary Outcome Measures :
  1. Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures. [ Time Frame: During surgical procedure ]

Eligibility Criteria
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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083809


Locations
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United States, Hawaii
University of Hawaii
Honolulu, Hawaii, United States, 96826
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Hawaii
Society of Family Planning
University of Washington
  Study Documents (Full-Text)

Documents provided by Bliss Kaneshiro, University of Hawaii:
Study Protocol and Statistical Analysis Plan  [PDF] August 26, 2014

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bliss Kaneshiro, Professor of Obstetrics & Gynecology, University of Hawaii
ClinicalTrials.gov Identifier: NCT02083809    
Other Study ID Numbers: OxyDE
First Posted: March 11, 2014    Key Record Dates
Results First Posted: November 27, 2020
Last Update Posted: November 27, 2020
Last Verified: November 2020
Additional relevant MeSH terms:
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Hemorrhage
Dilatation, Pathologic
Pathologic Processes
Pathological Conditions, Anatomical
 Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs