Please select the eligibility criteria that correspond to the clinical trial below.
Title: Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care
Brief Summary: This study concerns women diagnosed with postpartum hemorrhage and requiring sulprostone therapy. Included patients are randomized to two arms: the "Sulprostone + Bakri balloon" arm versus the "Sulprostone alone" arm.

The main objective of this study is to compare the efficiency of a care strategy including the Bakri balloon to that of routine care without the Bakri balloon via a cost-consequence study juxtaposing costs and the necessity of invasive procedures (arterial embolization, ligation of arteries, hysterectomy, intrauterine sutures) for controlling postpartum hemorrhage.


Options:
A: Inclusion Criteria:

* The patient, her person-of-trust, must have given his/her consent and signed the consent form / inclusion decision made by the investigator when a person-of-trust is absent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is able to fluently read and speak French
* Blood loss \> 500ml and sulprostone treatment is insufficient at 20 minutes
* Duration of pregnancy \> 32 weeks of amenorrhea
* Uterine atony

Exclusion Criteria:

* The patient is participating in another study except for the followin studies: ElastoMAP, ElastoDéclench, Papillo PMA, GrossPath, LXRs, DGPostPartum
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient cannot read French
* The patient was transferred to another center not among the centers participating in this study
* The patient has a contraindication for a treatment used in this study (Sulprostone), or an incompatible treatment combination
* The patient has a contraindication for third level techniques
* The patient has at least one of the following conditions: chorioamnionitis, cervical cancer, uterine rupture, anatomical abnormality preventing the introduction of the device, purulent infection of the vagina, cervix or uterus.
B: All legally adult women with postpartum haemorrhage following vaginal or caesarean section delivery who have a clinical diagnosis of postpartum haemorrhage. The clinical diagnosis of PPH may be based on any of the following:

* Blood loss after vaginal delivery \> 500 mL OR
* \> 1,000 mL after caesarean section OR blood loss sufficient to compromise the haemodynamic status of the woman The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use an antifibrinolytic agent in a particular woman with postpartum haemorrhage.
* Women for whom the responsible doctor considers there is a clear indication for antifibrinolytic therapy should not be randomised.
* Women for whom there is considered to be a clear contraindication to antifibrinolytic therapy should not be randomised.

Where the responsible clinician is substantially uncertain as to whether or not to use an antifibrinolytic, all these women are eligible for randomisation and should be considered for the trial.

There are no other pre-specified exclusion criteria.
C: Eligibility for stepped wedge trial:

Inclusion Criteria:

* Vaginal delivery at participating facility or referred to participating facility for PPH after vaginal delivery elsewhere

Exclusion Criteria:

* Delivery via Cesarean section
* Transferred to another facility before delivery
* Transferred to the participating facility after vaginal delivery elsewhere but died before arrival

Eligibility for nested cohort analysis:

Inclusion criteria

* Vaginal delivery at participating facility or referred to participating facility for PPH after vaginal delivery elsewhere
* Diagnosed and treated for PPH during the stepped wedge trial
* Willing and able to give informed consent
* Agree to participate in a postpartum interview before hospital discharge
* Agree to brief follow-up interview 4 weeks after delivery

Exclusion criteria

* Delivery via Cesarean section
* Transferred to another facility before delivery
* Transferred to the participating facility after vaginal delivery elsewhere but died before arrival
D: Inclusion Criteria:

* Patient undergoing caesarean sections landing up in atonic PPH during LSCS with failure of medical line of management:

  1. Full term pregnancy
  2. Didn't complete her family
  3. Elective caesarian section

Exclusion Criteria:

* 1.) PPH after vaginal delivery 2.) Secondary PPH 3.) PPH due to causes other than atonicity 4.) Antepartum hemorrhage cases 5.) Patients with bleeding tendency 6.) If any complication occurred during caesarian section (e.g. bladder injury, DIC)

Answer: A