Intrauterine Tamponade With a Belfort-Dildy Balloon in the Treatment of Immediate Postpartum Hemo… (NCT02226731) | Clinical Trial Compass
CompletedNot Applicable
Intrauterine Tamponade With a Belfort-Dildy Balloon in the Treatment of Immediate Postpartum Hemorrhage
France405 participantsStarted 2017-02-08
Plain-language 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 to first-line uterotonic treatment, ie performed at the same time as second line uterotonic treatment, as compared tolate intrauterine tamponade performed in case of failure of second line uterotonic treatment, on the final severity of PPH. ).
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Proportion of women who received at least 3 RBC units for the treatment of PPH and /or who had a calculated peripartum blood loss > 1000 ml.