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Intrauterine Tamponade With a Belfort-Dildy Balloon in the Treatment of Immediate Postpartum Hemorrhage (TUB)

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ClinicalTrials.gov Identifier: NCT02226731
Recruitment Status : Recruiting
First Posted : August 27, 2014
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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 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. ).

Condition or disease Intervention/treatment Phase
Immediate Postpartum Hemorrhage Device: Early Belfort-Dildy Balloon Device: Late Belfort-Dildy balloon Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Efficacy of Early Intrauterine Tamponade With a Belfort-Dildy Balloon Obstetric Tamponade System in the Treatment of Immediate Postpartum Hemorrhage
Actual Study Start Date : February 8, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Belfort-Dildy balloon device Device: Early Belfort-Dildy Balloon
Intrauterine tamponade with the Belfort-Dildy balloon, performed in the 15 minutes after randomization at the same time as the second line uterotonic treatment.

Late Belfort-Dildy balloon device Device: Late Belfort-Dildy balloon
Intrauterine tamponade with the Belfort-Dildy balloon, performed if failure of second line uterotonic treatment, ie persisting bleeding 30 minutes after the beginning of this infusion.




Primary Outcome Measures :
  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. [ Time Frame: 1 day ]
    With Calculated peripartum blood loss= estimated blood volume × ((prepartum Ht - Day 2postpartum Ht)/prepartum Ht ) and Estimated blood volume (ml) = booking weight (kg) × 85)


Secondary Outcome Measures :
  1. Other markers of severe hemorrhage [ Time Frame: 1 day ]
    - Incidence of each component of the primary outcome

  2. Other markers of severe hemorrhage [ Time Frame: 24 hours ]
    - Proportion of women with a total blood loss in the first 24 hours postpartum ≥ 1500 mL (estimated or measured).

  3. Other markers of severe hemorrhage [ Time Frame: 8 days ]
    - Proportion of women receiving a postpartum RBC transfusion

  4. Other markers of severe hemorrhage [ Time Frame: 8 days ]
    - Mean number of units of packed red blood cells transfused in postpartum

  5. Other markers of severe hemorrhage [ Time Frame: 8 days ]
    - Proportion of women receiving at least 4 units of packed red blood cells.

  6. Other markers of severe hemorrhage [ Time Frame: 2 days ]
    - 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.

  7. Other markers of severe hemorrhage [ Time Frame: 2 days ]
    - 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.

  8. Other markers of severe hemorrhage [ Time Frame: 2 days ]
    • 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

  9. Other markers of severe hemorrhage [ Time Frame: 2 days ]
    • •Total calculated peripartum blood loss

  10. Other markers of severe hemorrhage [ Time Frame: 2 days ]
    • Proportion of women with a total calculated peripartum blood loss ≥ 1500 mL

  11. Other markers of severe hemorrhage [ Time Frame: 2 days ]
    - Proportion of women transferred to Intensive care unit

  12. Other markers of severe hemorrhage [ Time Frame: 1 days ]
    - Proportion of women who had invasive second line therapy, any of the following : arterial embolization, pelvic arterial ligation, uterine compression suture, hysterectomy

  13. other Genital tract infection [ Time Frame: 8 days ]

    Assessed by :

    • Proportion of women with a temperature >38°5C during postpartum hospitalization

  14. other Genital tract infection [ Time Frame: 8 days ]

    Assessed by :

    • Proportion of women with endometritis during postpartum hospitalization.

  15. other Genital tract infection [ Time Frame: 6 weeks ]

    Assessed by :

    • Proportion of women who had endometritis at the 6 weeks postpartum visit.


  16. Other markers of severe hemorrhage [ Time Frame: 8 days ]
    Number of women who died in the postpartum"



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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
  • or who refuses to sign the informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226731


Contacts
Contact: Patrick ROZENBERG, MD +33 (0) 1 39 27 52 57 prozenberg@chi-poissy-st-germain.fr
Contact: Laurence Lecomte, PhD +33 1 58 41 35 45 laurence.lecomte@nck.aphp.fr

Locations
France
CHI de Poissy Saint Germain en Laye Recruiting
Poissy, France, 78303
Contact: Patrick ROZENBERG, MD,    +33 (0) 1 39 27 52 57    prozenberg@chi-poissy-st-germain.fr   
Contact: Laurence Lecomte, PhD    +33 1 71 19 64 94    laurence.lecomte@nck.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Patrick ROZENBERG, MD Department of Obstetrics, Poissy-Saint Germain Hospital Center
Study Director: Catherine DENEUX - THARAUX, MD, PhD Institut National de la Santé Et de la Recherche Médicale, France

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02226731     History of Changes
Other Study ID Numbers: P130914
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Immediate postpartum hemorrhage
Intrauterine balloon tamponade

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage