Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation

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.

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Key information

Conditions

Abortion Blood Loss Dilatation, Pathologic Dilation and Evacuation Hemorrhage Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

14 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Hawaii, Honolulu, Hawaii, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous Oxytocin

Drug

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

Intravenous Fluids and Electrolytes

Drug

500 ml of inert IV fluid

Primary outcomes

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

Time frame: During surgical procedure

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

Society of Family Planning
University of Washington

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Mar 11, 2014
Registry last updated: Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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