Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison Between Celox Versus Bakri Balloon for Treatment of Primary Atonic Postpartum Hemorrhage
Brief Summary: Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide reaching as high as 60% in some countries.

Postpartum hemorrhage is defined as loss of 500 mL or more in a vaginal delivery and 1 Litre or more in a cesarean delivery.Also any blood loss that cause hemodynamic instability should be considered a PPH.

In 2012, WHO updated the guidelines for the management of PPH and retained placenta to include: "The use of intrauterine balloon tamponade is recommended for the treatment of PPH due to uterine atony. This recommendation is now stronger than the previous guidelines. It can be used for women who do not respond to uterotonics or if uterotonics are not available. This procedure potentially can avoid surgery and is appropriate while awaiting transfer to a higher-level facility".Furthermore, FIGO included Uterine balloon tamponade as a recommended second-line intervention for the treatment of PPH in their updated guidelines issued in 2012.

In 2006, the ACOG Practice Bulletin, published by the American College of Obstetricians and Gynecologists, made mention of the Bakri postpartum balloon for its specifically tailored design that enables conservative management of uterine bleeding in cases of uterine atony and other causes of PPH.

The reports demonstrated that balloon tamponade is helpful in managing PPH secondary to a wide variety of causes in resource-poor settings.

One of the new methods that could be used to control PPH is Uterine packing with chitosan-covered gauze or Celox.

Celox Haemostats are dressings with natural material called chitosan to control major haemorrhage including life-threatening bleeding . They are simple and effective, stopping major bleeding.It was first used by military forces to stop sever bleeding in the scene with no other options to stop bleeding. Celox™ granules are actually very high surface area flakes. When they come in contact with blood, Celox™ swells, gels, and sticks together to make a gel like clot, without generating any heat. Celox™ does not set off the normal clotting cascade, it only clots the blood it comes directly into contact with. Celox works on casualties using anticoagulants and anti-platelet therapy such as aspirin .


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:

* 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)
C: Inclusion Criteria:

* all pregnant women with a single-term fetus scheduled for elective CD for complete placenta previa

Exclusion Criteria:

* • Patients with the cardiac, hepatic, renal, or thromboembolic disease;

  * patients with the high possibility of morbid adherent placenta;
  * known coagulopathy, and
  * those presented with severe antepartum hemorrhage were excluded.
D: 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

Answer: D