Quick balloon treatment may reduce severe bleeding after delivery
NCT ID NCT02226731
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested whether placing a balloon in the uterus early (within 15 minutes) helps control heavy bleeding after vaginal birth better than waiting 30 minutes. It included 405 women who had persistent bleeding after standard medication. The goal was to see if early balloon use reduces the need for blood transfusions or severe blood loss.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Belfort-Dildy balloon catheter (a device placed in the uterus to stop bleeding)
- What this could lead to
- If early balloon use works better, it could become a standard step to control severe postpartum bleeding and reduce the need for blood transfusions.
- What could go wrong
- This is a completed trial, but the benefit of early versus late balloon use may be small or not apply to all hospitals. The device itself carries risks like infection or injury.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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405 people
The number who actually took part.
- Started
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Feb 2017
- Finished
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Aug 2020
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: The trial will include women: * aged 18 years or older, * who have just had a vaginal delivery * between 35 and 42 weeks of gestation * with a PPH persisting 15 minutes after the injection of 5 UI or 10 IU of oxytocin by slow IV and uterine massage, * and who provided informed written consent. If her condition does not allow her consent to be obtained immediately in ethically acceptable conditions, it may be obtained from her healthcare agent, or if there is none, from a family member, if present. In case where neither a healthcare agent nor a family member is present on the day of inclusion, the patient can nonetheless be included. She will be informed secondarily, and her consent will be requested for the potential continuation of the research and use of her data * Patient beneficiary or affiliated to a health insurance Exclusion Criteria: The trial will not include women: * who have just had a cesarean delivery * with a contraindication to Sulprostone * with clinical chorioamnionitis or an in utero fetal death * or a medically-indicated termination of pregnancy * with PPH secondary to cervicovaginal lacerations without any uterine hemorrhage, uterine rupture, or placenta accreta * with arterial bleeding requiring embolization * with a purulent infection of the cervix, vagina or uterus * with symptoms indicating a hysterectomy * with cervical cancer * with a uterine malformation * or who refuses to sign the informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHI de Poissy Saint Germain en Laye
Poissy, 78303, France
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