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NCT02083809 Clinical Trial

Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation

Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02083809
Other study ID # OxyDE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2014
Est. completion date February 2018

Study information
Verified date November 2020
Source University of Hawaii
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 166
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender Female
Age group 14 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• intravenous oxytocin
30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)
• Intravenous Fluids and Electrolytes
500 ml of inert IV fluid

Locations
Country Name City State
United States University of Hawaii Honolulu Hawaii
United States University of Washington Seattle Washington

Sponsors (3)
Lead Sponsor Collaborator
University of Hawaii Society of Family Planning, University of Washington

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures. During surgical procedure
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