Intrauterine Tamponade With a Belfort-Dildy Balloon in the Treatment of Immediate Postpartum Hemorrhage
Intrauterine Tamponade With a Belfort-Dildy Balloon 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.
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.