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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Abortion
• Blood Loss
• Dilation and Evacuation
• Hemorrhage

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