Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation

Not Applicable

Completed

• Conditions: Abortion; Dilation and Evacuation; Hemorrhage; Blood Loss
• Interventions: Drug: Intravenous Fluids and Electrolytes; Drug: intravenous oxytocin

• Registration Number: NCT02083809
• Lead Sponsor: University of Hawaii

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 available

Study Timeline

• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-11
• Study Start: 2014-10
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Results First Submitted: 2020-10-02
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-25
• Last Update Submitted: 2020-11-25
• Results First Posted: 2020-11-27
• Last Update Posted: 2020-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 166

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Intravenous Fluids and Electrolytes	500ml saline or lactated ringer without oxytocin added
Treatment group	intravenous oxytocin	Intravenous oxytocin mixed with saline or lactated ringer

Primary Outcome Measures

Name	Time	Method
Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures.	During surgical procedure

Trial Locations

Locations (2)

University of Hawaii; 🇺🇸 Honolulu, Hawaii, United States

University of Washington; 🇺🇸 Seattle, Washington, United States