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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation

NCTNCT02083809 (opens ClinicalTrials.gov in a new tab)Other idOxyDE
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
166 participants (actual)
Sponsor
University of Hawaii · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Oct 2014
Primary completion
Feb 2018
Completion
Feb 2018
First posted
11 Mar 2014 (estimated)
Last update posted
27 Nov 2020
Conditions
Abortion · Dilation and Evacuation · Hemorrhage · Blood Loss

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016201720182019
  1. N/A

    Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation

    NCT02083809

    Oct 2014 to Feb 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • intravenous oxytocinDrug
  • Intravenous Fluids and ElectrolytesDrug

Arms2

  • Placebo comparator

    Placebo

    500ml saline or lactated ringer without oxytocin added

  • Active comparator

    Treatment group

    Intravenous oxytocin mixed with saline or lactated ringer

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · During surgical procedure

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· During surgical procedure

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

GroupValue (Participants)
Placebo13
Treatment Group6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placebo500ml saline or lactated ringer without oxytocin added Intravenous Fluids and Electrolytes: 500 ml of inert IV fluid0 / 781 / 780 / 78
Treatment GroupIntravenous oxytocin mixed with saline or lactated ringer intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)0 / 821 / 820 / 82

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2019

Corrected

Effects of Prophylactic Oxytocin on Bleeding Outcomes in Women Undergoing Dilation and Evacuation: A Randomized Controlled Trial.

Whitehouse et al. 2019Obstetrics and gynecologycited by 17

PMID 30741801DOI 10.1097/aog.0000000000003104PUB-30741801

Rights unknown
Source linkRead the notice

Eligibility

Who could join, as posted.

Sex
Female
Age
from 14 Years up to 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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