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Device
Intrauterine Balloon Tamponade for Postpartum Hemorrhage
N/A
Waitlist Available
Research Sponsored by Denver Health and Hospital Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 hours
Awards & highlights
Study Summary
This trial will help determine if an intrauterine balloon tamponade placed to control postpartum hemorrhage is just as effective when used for shorter durations of time.
Who is the study for?
This trial is for women at Denver Health who've had an IUBT placed for postpartum hemorrhage due to uterine atony. Participants must be adults able to consent, not have clotting disorders or be on anticoagulants, and can't refuse blood transfusions. Those with fetal demise or nonviable births, or are incarcerated are excluded.Check my eligibility
What is being tested?
The study tests if a shorter duration (6 hours) of intrauterine balloon tamponade is as effective as the standard longer duration (18 hours) in controlling postpartum hemorrhage without increasing blood loss or related morbidity.See study design
What are the potential side effects?
While specific side effects aren't listed, potential risks may include discomfort from the balloon tamponade, possible infection risk from prolonged device placement, and complications related to ineffective hemorrhage control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during admission
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during admission
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quantitative blood loss
Secondary outcome measures
Chorioamnionitis
Endometritis
Hematocrit
+5 moreTrial Design
2Treatment groups
Active Control
Group I: 6 hour IUBT placementActive Control1 Intervention
Group II: 18 hour IUBT placementActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Denver Health and Hospital AuthorityLead Sponsor
101 Previous Clinical Trials
400,333 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: 6 hour IUBT placement
- Group 2: 18 hour IUBT placement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Which patient population is best suited for this clinical experimentation?
"To be considered for inclusion in this clinical trial, individuals must suffer from postpartum haemorrhage and are aged between 18-55. The research seeks to enrol 64 participants overall."
Answered by AI
Are there any available slots for participants in this trial?
"The clinicaltrials.gov website seems to suggest that this medical trial is not actively accepting participants at the moment, as its last update was on November 16th 2021. Despite this, there are a plentitude of other trials currently recruiting patients."
Answered by AI
Does this research encompass individuals of thirty years and older?
"This medical study is recruiting adults aged 18 or over and under 55 years old."
Answered by AI
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