Immediate Postpartum Hemorrhage Clinical Trial
— TUBOfficial title:
Assessment of the Efficacy of Early Intrauterine Tamponade With a Belfort-Dildy Balloon Obstetric Tamponade System in the Treatment of Immediate Postpartum Hemorrhage
Verified date | June 2020 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. ).
Status | Completed |
Enrollment | 405 |
Est. completion date | August 18, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | CHI de Poissy Saint Germain en Laye | Poissy |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Institut National de la Santé Et de la Recherche Médicale, France |
France,
Georgiou C. Balloon tamponade in the management of postpartum haemorrhage: a review. BJOG. 2009 May;116(6):748-57. doi: 10.1111/j.1471-0528.2009.02113.x. Review. — View Citation
Laas E, Bui C, Popowski T, Mbaku OM, Rozenberg P. Trends in the rate of invasive procedures after the addition of the intrauterine tamponade test to a protocol for management of severe postpartum hemorrhage. Am J Obstet Gynecol. 2012 Oct;207(4):281.e1-7. doi: 10.1016/j.ajog.2012.08.028. Epub 2012 Aug 17. — View Citation
Revert M, Cottenet J, Raynal P, Cibot E, Quantin C, Rozenberg P. Intrauterine balloon tamponade for management of severe postpartum haemorrhage in a perinatal network: a prospective cohort study. BJOG. 2017 Jul;124(8):1255-1262. doi: 10.1111/1471-0528.14382. Epub 2016 Oct 25. — View Citation
Tindell K, Garfinkel R, Abu-Haydar E, Ahn R, Burke TF, Conn K, Eckardt M. Uterine balloon tamponade for the treatment of postpartum haemorrhage in resource-poor settings: a systematic review. BJOG. 2013 Jan;120(1):5-14. doi: 10.1111/j.1471-0528.2012.03454.x. Epub 2012 Aug 13. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | With Calculated peripartum blood loss= estimated blood volume × ((prepartum Ht - Day 2postpartum Ht)/prepartum Ht ) and Estimated blood volume (ml) = booking weight (kg) × 85) | 1 day | |
Secondary | Other markers of severe hemorrhage | Incidence of each component of the primary outcome | 1 day | |
Secondary | Other markers of severe hemorrhage | Proportion of women with a total blood loss in the first 24 hours postpartum = 1500 mL (estimated or measured). | 24 hours | |
Secondary | Other markers of severe hemorrhage | Proportion of women receiving a postpartum RBC transfusion | 8 days | |
Secondary | Other markers of severe hemorrhage | Mean number of units of packed red blood cells transfused in postpartum | 8 days | |
Secondary | Other markers of severe hemorrhage | Proportion of women receiving at least 4 units of packed red blood cells. | 8 days | |
Secondary | Other markers of severe hemorrhage | Proportion of women with a difference = 4 g/dL between the hemoglobin value before and on the 2nd day after delivery in the absence of a transfusion of packed red blood cells. | 2 days | |
Secondary | Other markers of severe hemorrhage | Mean difference between the hemoglobin values before delivery and on the 2nd day postpartum in the absence of a transfusion of packed red blood cells. | 2 days | |
Secondary | Other markers of severe hemorrhage | Mean difference between the hematocrit values before delivery and on the 2nd day postpartum in the absence of a transfusion of packed red blood cells . |
2 days | |
Secondary | Other markers of severe hemorrhage | Total calculated peripartum blood loss . |
2 days | |
Secondary | Other markers of severe hemorrhage | Proportion of women with a total calculated peripartum blood loss = 1500 mL . |
2 days | |
Secondary | Other markers of severe hemorrhage | Proportion of women transferred to Intensive care unit | 2 days | |
Secondary | Other markers of severe hemorrhage | Proportion of women who had invasive second line therapy, any of the following : arterial embolization, pelvic arterial ligation, uterine compression suture, hysterectomy | 1 day | |
Secondary | other Genital tract infection | Assessed by : Proportion of women with a temperature >38°5C during postpartum hospitalization |
8 days | |
Secondary | other Genital tract infection | Assessed by : Proportion of women with endometritis during postpartum hospitalization. |
8 days | |
Secondary | other Genital tract infection | Assessed by : • Proportion of women who had endometritis at the 6 weeks postpartum visit. |
6 weeks | |
Secondary | Other markers of severe hemorrhage | Proportion of women with a total blood loss in the first 24 hours postpartum = 2000 mL (estimated or measured) | 24 hours | |
Secondary | Other markers of severe hemorrhage | Proportion of women with a total calculated peripartum blood loss = 2000 mL | 2 days |
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