Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation

NCT02083809 | Completed Results DMC

• 1 other identifier: OxyDE
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 2

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.

Conditions

Abortion; Dilation and Evacuation; Hemorrhage; Blood Loss

Outcome Measures

Primary Outcomes (1)

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

  During surgical procedure

Study Arms (2)

Placebo

PLACEBO COMPARATOR

500ml saline or lactated ringer without oxytocin added

Drug: Intravenous Fluids and Electrolytes

Treatment group

ACTIVE COMPARATOR

Intravenous oxytocin mixed with saline or lactated ringer

Drug: intravenous oxytocin

Interventions

intravenous oxytocin DRUG

30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)

Treatment group

Intravenous Fluids and Electrolytes DRUG

500 ml of inert IV fluid

Placebo

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Ultrasound findings suggestive of placenta accreta
• Patients requiring preoperative misoprostol

Sponsors & Collaborators

• University of Hawaii: lead
• Society of Family Planning: collaborator
• University of Washington: collaborator

Study Sites (2)

University of Hawaii

Honolulu, Hawaii, 96826, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• 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.

  PMID: 30741801 DERIVED

MeSH Terms

Conditions

Dilatation, Pathologic; Hemorrhage

Interventions

Electrolytes

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Results Point of Contact

• Title: Dr.
• Organization: University of Hawaii

whrc@ucera.org

8082036500

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics & Gynecology

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 11, 2014
• Study Start: October 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: November 27, 2020
• Results First Posted: November 27, 2020

Record last verified: 2020-11

Locations

US (2)