Immediate Postpartum Hemorrhage Clinical Trial
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
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. ).
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 observational studies, the available
evidence suggests that it is associated with a drop in the need for invasive treatments.
Based on this evidence, intra-uterine tamponade balloon has been included in guidelines for
PPH treatment in many countries, including France, and it has widely spread in clinical
practices. The clinical question that is now arising is its optimal timing in the management
of PPH. It is currently classically performed after failure of second-line uterotonic
treatment but it is possible that its earlier use, after failure of first-line uterotonic
treatment, could further decrease the rate of severe PPH.
A randomized controlled trial is therefore necessary to determine the optimal timing of
intrauterine balloon tamponade in the treatment of PPH. .
We propose a multicenter, randomized open treatment trial with two parallel arms. The trial
will be conducted in 21 maternity units. Before inclusions begin, the medical staff will be
trained in the use of the obstetric tamponade system to be used in the trial. For each woman
with IPPH refractory to first line uterotonic, the eligibility criteria will be immediately
verified, the woman informed and her written informed consent obtained if that is possible.
If not, the woman can nonetheless be randomized and she will be secondarily informed and her
consent requested. The randomization list will be centralized and generated by a computer
program under the supervision of the Paris Centre Clinical Research Unit. Allocation to a
study arm will be performed on a secure Internet platform (CleanWeb) always accessible (24/7)
in each delivery room. The clinician including the patient will know her allocation
immediately.
The management of randomized women will depend on the arm to which they are allocated:
- In the Experimental arm : the intravenous second line uterotonic Sulprostone infusion
will be immediately combined with an intrauterine tamponade with the Belfort-Dildy
balloon. Balloon insertion and inflation will follow a standardized protocol. Its
intrauterine position will be verified by abdominal ultrasound. If the bleeding persists
from the cervix or the balloon catheter drainage port 30 minutes after the beginning of
the Sulprostone infusion, the tamponade will be considered a failure and an invasive
emergency procedure by interventional radiology or surgery will be arranged and
performed immediately after the removal of the balloon in the operating room.
- In the Control arm, women will only receive the Sulprostone infusion first. If bleeding
persists 30 minutes after the beginning of this infusion, an intrauterine tamponade with
the Belfort-Dildy balloon will be performed. Balloon insertion and inflation will be
performed following the standardized protocol. If the bleeding persists from the cervix
or the balloon catheter drainage port 15 to 30 minutes after the introduction of the
balloon, the tamponade will be considered a failure and an invasive emergency procedure
by interventional radiology or surgery will be arranged and performed immediately after
the removal of the balloon in the operating room.
In both arms, all patients will have an indwelling urinary catheter and will receive
antibiotic prophylaxis (amoxicillin-clavulanic acid and gentamicin) beginning with the
Sulprostone infusion and continuing for 48 hours. The other components of IPPH management
(fluid resuscitation, transfusion, resuscitation) will comply with national guidelines. If
the bleeding stops, the patient will be transferred to a continuous care or
post-interventional monitoring unit. Monitoring will be conducted by the investigator who
included the patient. A venous blood sample will be collected on the 2nd day postpartum to
measure hemoglobin and hematocrit values. The data will be entered as they are collected
throughout the trial with Cleanweb software.
The duration of the participation of each patient included in the trial will be from
inclusion through postpartum visit, or a maximum of approximately 8 weeks after the delivery.
The maximum duration of study treatment will be 24 hours for each patient included in the
protocol.
The total duration of the trial will be 36 months including 24 months of patient inclusion:
the first 4 months, before the beginning of the inclusion period will be devoted to training
staff in the use of the balloon tamponade system and in compliance with the trial protocol
and the 8 months following the end of the inclusion period will be used to finalize the data
collection, clean the database and analyze it.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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|
N/A | |
| Completed |
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Phase 3 |