MedDataX Logo

Minimum Effective Duration of Intrauterine Balloon Tamponade for the Management of Postpartum Hemorrhage

NCT ID: NCT04467996

Last Updated: 2022-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-19

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Intrauterine balloon tamponade (IUBT) is recommended worldwide as the second-line therapy to treat postpartum hemorrhage. While much literature demonstrates the effectiveness of this therapy, little is known about how long the IUBT should be used once placed. Though it is common to use IUBT for 12-24 hours, the balloon may be equally effective when used for shorter durations of time, which could have beneficial effects for patients and hospitals. The proposed study is a pragmatic randomized controlled trial of non-inferiority comparing two durations of time for intrauterine balloon tamponade placement, 6 and 18 hours, in controlling postpartum hemorrhage.

The specific aims of the proposed study are to determine: 1) whether quantitative blood loss significantly differs when the balloon is removed in 6 hours compared to 18 hours, 2) whether hemorrhage-related morbidity differs when the IUBT is kept in place for 6 or 18 hours, and 3) whether shorter duration of IUBT placement has beneficial effects including shortened postpartum hospital stays, improved maternal-infant bonding, and reduced postpartum pain prior to maternal discharge from hospital.

We hypothesize that, once hemorrhage control has been achieved with IUBT placement, there is no clinically significant difference in postpartum blood loss when the balloon is removed 6 hours after placement compared to 18 hours after placement.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postpartum Hemorrhage, Immediate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

6 hour IUBT placement

Group Type ACTIVE_COMPARATOR

Intrauterine balloon tamponade

Intervention Type DEVICE

Intrauterine balloon will be placed in the uterus for postpartum hemorrhage control.

18 hour IUBT placement

Group Type ACTIVE_COMPARATOR

Intrauterine balloon tamponade

Intervention Type DEVICE

Intrauterine balloon will be placed in the uterus for postpartum hemorrhage control.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intrauterine balloon tamponade

Intrauterine balloon will be placed in the uterus for postpartum hemorrhage control.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women at Denver Health and Hospital Authority (DHHA) who have an IUBT placed for postpartum hemorrhage due to uterine atony will be approached for enrollment in the study.

Exclusion Criteria

* Women will be excluded from the study if they: are less than 18 years of age; had a cesarean delivery; are unable to consent for themselves; have a preexisting or acquired clotting factor disorder such as von Willebrand or hemophilia, disseminated intravascular coagulation, or therapeutic anticoagulation at time of delivery; would refuse blood product transfusion; have a fetal demise or birth of a previable fetus; or are incarcerated at the time of delivery. Women who do not speak English or Spanish will be offered enrollment if a phone interpreter is available to review the consent, but will be excluded from the survey portion of the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Denver Health and Hospital Authority

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

LARREANICOLE

Obstetrician Gynegologist, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Denver Health Hospital

Denver, Colorado, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19-3070

Identifier Type: -

Identifier Source: org_study_id