Please select the eligibility criteria that correspond to the clinical trial below.
Title: Introduction of a Uterine Balloon Tamponade for Postpartum Hemorrhage in Three Low Income Countries: a Stepped Wedge Cluster Randomized Trial
Brief Summary: This study is a prospective, systematic evaluation to assess the effectiveness and safety of introduction of UBT into PPH care at secondary level and district hospitals in 3 low-resource countries. The first component of the evaluation is a prospective stepped wedge cluster randomized design to assess the potential reduction in PPH-related mortality and invasive procedures (blood transfusion, arterial ligation, hysterectomy and uterine arterial embolization) for PPH performed at participating facilities following introduction of UBT. The second component is a nested cohort analysis to assess the safety and acceptability of UBT among women diagnosed with PPH.


Options:
A: To participate in these study activities, women must be willing and able to participate, be able to sign or mark a consent form, and speak one of the languages into which the consent form has been translated, including English, Nyanja, and Bemba in Zambia, and English, Shona and Ndebele in Zimbabwe.

Inclusion Criteria:

* Women who are pregnant or postpartum and experiencing obstetric hemorrhage with 2 of the following 3:

blood loss \> 500 mL (at SHF, 1000 mL at RH) SBP \<100 mm Hg pulse \>100 bpm

Exclusion Criteria:

* Absolute exclusion criteria include: current viable third trimester intrauterine pregnancy that can be delivered in the next 20 minutes after hemorrhage begins and/or current bleeding sites above the diaphragm. Relative exclusion criteria include: a history or current clinical evidence of mitral stenosis or congestive heart failure (CHF). These must be relative contraindications that will be assessed at the time of hemorrhage and clinical judgment will need to be utilized to evaluate each case individually. Thus if the patient can be transported and delivered rapidly and is suspected or known to have valvular heart disease, she will be excluded from the study. In other cases, depending on the severity of the hemorrhage, if the patient is dyspneic in the NASG, at the SHF level, the NASG will be loosened, if that does not result in relief, the NASG will be removed. If the patients at the RH have decreasing oxygen saturation levels as demonstrated by pulse oximeter, the NASG will be loosened, if that does not result in relief, the NASG will be removed.

Women suffering obstetric hemorrhage and hypovolemic shock who have no detectable vital signs (non palpable pulse and BP) at the time of their arrival at the RH are ineligible for enrolment in the study ("non-resuscitable") if: 1) the woman does not respond to resuscitation attempts after 30 minutes and 2) more than three hours have elapsed between the start of hemorrhage and the beginning of her treatment. (As this is a clinical intervention of a potentially life saving device, the study clinicians should try the NASG on any patient if they feel it may resuscitate her; however, if the woman meets the criteria above they are ineligible for having their data entered into the study.)
B: Inclusion Criteria:

* Women who accept to participate (either the patient or her first-kin if she is unconscious)
* Primary atonic postpartum hemorrhage

Exclusion Criteria:

* Traumatic postpartum hemorrhage
* With any suspected (e.g. prolonged rupture of membranes) or clinical evidence of infection
* Pre eclampsia.
* Diabetes mellietus(DM) with pregnancy
* History of Deep venous thrombosis (DVT) or other thromboembolic complication
* Rheumatic heart patients
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:

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.

Answer: C