Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation

• ClinicalTrials.gov Identifier: NCT02083809
• Recruitment Status: Completed
• First Posted: March 11, 2014
• Results First Posted: November 27, 2020
• Last Update Posted: November 27, 2020
• Sponsor: University of Hawaii
• Collaborators: Society of Family Planning; University of Washington
• Information provided by (Responsible Party): Bliss Kaneshiro, University of Hawaii

Tracking Information

• First Submitted Date: March 4, 2014
• First Posted Date: March 11, 2014
• Results First Submitted Date: October 2, 2020
• Results First Posted Date: November 27, 2020
• Last Update Posted Date: November 27, 2020
• Actual Study Start Date: October 2014
• Actual Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 6, 2014): Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures. [ Time Frame: During surgical procedure ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Abortion
• Dilation and Evacuation
• Hemorrhage
• Blood Loss

Intervention

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

Study Arms

• Placebo Comparator: Placebo
  500ml saline or lactated ringer without oxytocin added
  Intervention: Drug: Intravenous Fluids and Electrolytes
• Active Comparator: Treatment group
  Intravenous oxytocin mixed with saline or lactated ringer
  Intervention: Drug: intravenous oxytocin

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 6, 2014): 166
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 2018
• Actual Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 14 Years to 50 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02083809
• Other Study ID Numbers: OxyDE
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bliss Kaneshiro, University of Hawaii
• Study Sponsor: University of Hawaii

Collaborators

• Society of Family Planning
• University of Washington

• Investigators: Not Provided
• PRS Account: University of Hawaii
• Verification Date: November 2020