Status:
COMPLETED
Intrauterine Tamponade With a Belfort-Dildy Balloon in the Treatment of Immediate Postpartum Hemorrhage
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
URC-CIC Paris Descartes Necker Cochin
Conditions:
Immediate Postpartum Hemorrhage
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the impact of early intrauterine tamponade with a Belfort-Dildy balloon catheter in immediate postpartum hemorrhage(IPPH) after vaginal delivery and refractory...
Detailed Description
Immediate postpartum hemorrhage (IPPH) is among the most frequent causes of pregnancy-related mortality in both the USA and in Europe. In France, IPPH remains the leading cause of maternal mortality, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2020
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT02226731
Start Date
February 8 2017
End Date
August 18 2020
Last Update
September 5 2025
Active Locations (1)
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1
CHI de Poissy Saint Germain en Laye
Poissy, France, 78303