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Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation

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ClinicalTrials.gov Identifier: NCT02083809
Recruitment Status : Recruiting
First Posted : March 11, 2014
Last Update Posted : February 28, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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
Abortion Dilation and Evacuation Hemorrhage Blood Loss Drug: intravenous oxytocin Drug: Intravenous Fluids and Electrolytes

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : October 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Oxytocin
U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :
  1. Rate at which providers intervene to control blood loss during D&E procedures. [ Time Frame: During surgical procedure ]

Eligibility Criteria

Information from the National Library of Medicine

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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

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


Contacts
Contact: Bliss Kaneshiro, MD, MPH 808-203-6500 research@fpfellowshiphawaii.org
Contact: Kate Whitehouse, DO

Locations
United States, Hawaii
University of Hawaii Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Kate Whitehouse, DO         
Contact: Bliss Kaneshiro, MD, MPH         
Principal Investigator: Bliss Kaneshiro, MD, MPH         
Sub-Investigator: Kate Whitehouse, DO         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98104
Contact: Elizabeth Micks, MD, MPH         
Principal Investigator: Elizabeth Micks, MD, MPH         
Sponsors and Collaborators
University of Hawaii
Society of Family Planning
University of Washington
More Information

Responsible Party: Bliss Kaneshiro, Professor of Obstetrics & Gynecology, University of Hawaii
ClinicalTrials.gov Identifier: NCT02083809     History of Changes
Other Study ID Numbers: OxyDE
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Hemorrhage
Dilatation, Pathologic
Pathologic Processes
Pathological Conditions, Anatomical
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs