Clinical Trial: Intrauterine Tamponade With a Belfort-Dildy Balloon in the Treatment of Immediate Postpartum Hemorrhage

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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. ).

Detailed Summary:

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, responsible for 18% of the maternal deaths and 90% of the deaths from IPPH are considered avoidable. The initial treatment of severe IPPH involves medical management, uterine massage, and uterotonic drugs such as oxytocin, ergometrine, and prostaglandins or their analogues; In France oxytocin is used as the first line uterotonic, and Sulprostone as the second line uterotonic. When these first-line medical treatments fail, invasive therapies, including uterine compression suture, pelvic vascular ligation, or arterial embolization can be used, individually or in combination. Hysterectomy is the ultimate measure to control a hemorrhage and save the mother's life. Nonetheless, the management of severe IPPH is less well standardized than its prevention, especially after the failure of uterotonic drugs, as demonstrated by the heterogeneity of practices between countries and even between hospitals in the same country. These invasive treatments require specific and expensive technical and human resources and have adverse effects. That is why, over the last years, intra-uterine tamponade with balloon has been increasingly used; indeed, it is a new minimally invasive method that can be used directly in the delivery room, at the initial stage of second-line treatments; it could accelerate the control of IPPH, limit recourse to these surgical or interventional radiology treatments, and reduce the quantity of blood products transfused. Intrauterine balloon tamponade thus appears to be a potentially additional effective strategy for obtaining hemostasis in the case of IPPH refractory to conventional uterotonic treatments. Despite the fact that the current literature assessing its efficacy is limited to case series and before-after observa
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: 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)


Original Primary Outcome: Incidence of use of any second line invasive procedure (embolisation/surgery) for PPH treatment [ Time Frame: 1 day ]

Any of the following: arterial embolization, pelvic arterial ligation, uterine compression suture, hysterectomy


Current Secondary Outcome:

  • Other markers of severe hemorrhage [ Time Frame: 1 day ]
    - Incidence of each component of the primary outcome
  • 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).
  • Other markers of severe hemorrhage [ Time Frame: 8 days ]
    - Proportion of women receiving a postpartum RBC transfusion
  • Other markers of severe hemorrhage [ Time Frame: 8 days ]
    - Mean number of units of packed red blood cells transfused in postpartum
  • Other markers of severe hemorrhage [ Time Frame: 8 days ]
    - Proportion of women receiving at least 4 units of packed red blood cells.
  • 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.
  • 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.
  • 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
  • Other markers of severe hemorrhage [ Time Frame: 2 days ]
    • •Total calculated peripartum blood loss
  • Other markers of severe hemorrhage [ Time Frame: 2 days ]
    • Proportion of women with a total calculated peripartum blood loss ≥ 1500 mL
  • Other markers of severe hemorrhage [ Time Frame: 2 days ]
    - Proportion of women transferred to Intensive care unit
  • 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
  • other Genital tract infection [ Time Frame: 8 days ]

    Assessed by :

    • Proportion of women with a temperature >38°5C during postpartum hospitalization
  • other Genital tract infection [ Time Frame: 8 days ]

    Assessed by :

    • Proportion of women with endometritis during postpartum hospitalization.
  • other Genital tract infection [ Time Frame: 6 weeks ]

    Assessed by :

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

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


Original Secondary Outcome:

  • Other markers of severe hemorrhage [ Time Frame: 1 day ]
    - Incidence of use of each procedure of the primary outcome
  • 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).
  • Other markers of severe hemorrhage [ Time Frame: 8 days ]
    - Proportion of women receiving a postpartum RBC transfusion
  • Other markers of severe hemorrhage [ Time Frame: 8 days ]
    - Mean number of units of packed red blood cells transfused in postpartum
  • 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.
  • 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.
  • 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
  • Other markers of severe hemorrhage [ Time Frame: 2 days ]
    - Proportion of women transferred to Intensive care unit
  • Other markers of severe hemorrhage [ Time Frame: 8 days ]
    - Proportion of women receiving at least 4 units of packed red blood cells.
  • other Genital tract infection [ Time Frame: Day 8 ]

    Assessed by :

    • Proportion of women with a temperature >38°5C during pospartum hospitalization
  • other Genital tract infection [ Time Frame: Day 8 ]

    Assessed by :

    • Proportion of women with endometritis during postpartum hospitalization.


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: August 6, 2014
Date Started: January 2017
Date Completion: November 2019
Last Updated: February 2, 2017
Last Verified: January 2017