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Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation

Primary Purpose

Abortion, Dilation and Evacuation, Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
intravenous oxytocin
Intravenous Fluids and Electrolytes
Sponsored by
University of Hawaii
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abortion

Eligibility Criteria

14 Years - 50 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Hawaii
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Treatment group

Arm Description

500ml saline or lactated ringer without oxytocin added

Intravenous oxytocin mixed with saline or lactated ringer

Outcomes

Primary Outcome Measures

Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures.

Secondary Outcome Measures

Full Information

First Posted
March 4, 2014
Last Updated
November 25, 2020
Sponsor
University of Hawaii
Collaborators
Society of Family Planning, University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT02083809
Brief Title
Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation
Official Title
A Randomized Double-blinded Controlled Trial Comparing Dilation and Evacuation Outcomes With and Without Oxytocin Use
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hawaii
Collaborators
Society of Family Planning, University of Washington

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion, Dilation and Evacuation, Hemorrhage, Blood Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
500ml saline or lactated ringer without oxytocin added
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
Intravenous oxytocin mixed with saline or lactated ringer
Intervention Type
Drug
Intervention Name(s)
intravenous oxytocin
Intervention Description
30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)
Intervention Type
Drug
Intervention Name(s)
Intravenous Fluids and Electrolytes
Intervention Description
500 ml of inert IV fluid
Primary Outcome Measure Information:
Title
Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures.
Time Frame
During surgical procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30741801
Citation
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.
Results Reference
derived

Learn more about this trial

Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation

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