Postpartum Hemorrhage, ImmediateNCT04467996
Minimum Effective Duration of Intrauterine Balloon Tamponade for the Management of Postpartum Hemorrhage
A study testing Intrauterine balloon tamponade in people with Postpartum Hemorrhage, Immediate, run by Denver Health and Hospital Authority at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Postpartum Hemorrhage, Immediate
- What is being tested?
- Intrauterine balloon tamponade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2020to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Minimum Effective Duration of Intrauterine Balloon Tamponade for the Management of Postpartum Hemorrhage: A Randomized Controlled Trial
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.
- Conditions
- Postpartum Hemorrhage, Immediate
- Being tested
- Intrauterine balloon tamponade
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine balloon tamponadeDevice
Intrauterine balloon will be placed in the uterus for postpartum hemorrhage control.
| Study group | Role | What they receive |
|---|---|---|
| 6 hour IUBT placement | Active comparator | Not described Receives: Device: Intrauterine balloon tamponade |
| 18 hour IUBT placement | Active comparator | Not described Receives: Device: Intrauterine balloon tamponade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative blood loss
total blood loss includes output from the intrauterine balloon plus blood loss from sanitary pads
Measured: 18 hours
Secondary outcomes (8)
Postpartum hemorrhage related outcomes
return to the OR, replacement of the IUBT, hysterectomy, pelvic artery embolization
Measured: during admission
Hematocrit
change in hematocrit from admission to discharge
Measured: during admission
Postpartum length of stay
Length of stay in hours
Measured: during admission
Endometritis
diagnosed postpartum
Measured: during admission
Chorioamnionitis
requiring more than one dose of antibiotics postpartum
Measured: during admission
Transfusion of packed red blood cells
after IUBT placement
Measured: during admission
Maternal-infant bonding
measured by the mother-to-infant bonding scale (MIBS), scale 0-27, higher score indicates worse maternal-infant bonding
Measured: during admission
Maternal pain
measured by the visual analogue scale (VAS), scale 0-10, higher score indicates worse pain
Measured: during admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start19 Oct 2020
- Primary completion1 Jun 2023
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum Hemorrhage, ImmediateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LARREANICOLE, Denver Health and Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467996
- Sponsor's protocol ID
- 19-3070
- Status last verified
- Nov 2025
- First submitted
- 8 Jul 2020
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Larrea N, Adkins K, Durfee J, Heyborne K, Schultz C. Intrauterine Balloon Tamponade Duration for Postpartum Hemorrhage: A Randomized Controlled Trial. Obstet Gynecol. 2026 Jul 1;148(1):113-120. doi: 10.1097/AOG.0000000000006295. Epub 2026 May 7.
PubMed 42096713
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Minimum Effective Duration of Intrauterine Balloon Tamponade for the Management of Postpartum Hemorrhage: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04467996
- Acronym / sponsor ID
- 19-3070
- Conditions
- Postpartum Hemorrhage, Immediate
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6 hour IUBT placement | Active comparator | Device: Intrauterine balloon tamponade |
| 18 hour IUBT placement | Active comparator | Device: Intrauterine balloon tamponade |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrauterine balloon tamponadeIntrauterine balloon will be placed in the uterus for postpartum hemorrhage control. | Device | 18 hour IUBT placement, 6 hour IUBT placement |
Primary outcome
Quantitative blood loss
Time frame: 18 hours
total blood loss includes output from the intrauterine balloon plus blood loss from sanitary pads
8 secondary outcomes
Postpartum hemorrhage related outcomes
Time frame: during admission
Hematocrit
Time frame: during admission
Postpartum length of stay
Time frame: during admission
Endometritis
Time frame: during admission
Chorioamnionitis
Time frame: during admission
Transfusion of packed red blood cells
Time frame: during admission
Maternal-infant bonding
Time frame: during admission
Maternal pain
Time frame: during admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Derived from this study: PubMed 42096713Larrea N, Adkins K, Durfee J, Heyborne K, Schultz C. Intrauterine Balloon Tamponade Duration for Postpartum Hemorrhage: A Randomized Controlled Trial. Obstet Gynecol. 2026 Jul 1;148(1):113-120. doi: 10.1097/AOG.0000000000006295. Epub 2026 May 7.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrauterine balloon tamponade in people with Postpartum Hemorrhage, Immediate, run by Denver Health and Hospital Authority at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative blood loss (time frame: 18 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04467996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.