Please select the eligibility criteria that correspond to the clinical trial below.
Title: Non-Pneumatic Anti-Shock Garment for Obstetrical Hemorrhage: Zambia and Zimbabwe
Brief Summary: This trial will address the question of whether early application of the Non-pneumatic Anti-Shock Garment (NASG) at the Satellite Health Facility (SHF) level before transport to a Referral Hospital (RH) will decrease maternal mortality and morbidity. The available evidence indicates that the NASG substantially decreases blood loss, but there is no evidence that its application will reduce extreme adverse outcomes. It is also not known if possible side effects associated with NASG use might outweigh potential benefits. This study would rigorously test the effectiveness of the NASG using an experimental design with adequate power to detect statistically significant decreases in morbidity and mortality.


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 18-45 years old who have just delivered they baby vaginally who now have uncontrolled bleeding from their uteri

Exclusion Criteria:

* anyone outside of the specified age group
* anyone who declines to participate in the study
C: Inclusion Criteria:

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

Exclusion Criteria:

1. Traumatic postpartum haemorrhage
D: 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

Answer: A