Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation

November 25, 2020 updated by: Bliss Kaneshiro, University of Hawaii

A Randomized Double-blinded Controlled Trial Comparing Dilation and Evacuation Outcomes With and Without Oxytocin Use

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • University of Hawaii
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures.
Time Frame: During surgical procedure
During surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hawaii

Collaborators

University of Washington
Society of Family Planning

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OxyDE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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