Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Comparative Study Between Bakri Balloon and B Lynch Suture Used to Control Primary Postpartum Hemorrhage After Cesarean Section
Brief Summary: Hundred (100) patients with primary postpartum hemorrhage during caesarean section due to atonic uterus will be recruited for this study.and randomized to either B lynch or Bakeri Ballon

B-Lynch:

A 70 mm round bodied hand needle on which a No. 2 absorbable suture is mounted is used to puncture the uterus 3 cm from the right lower edge of the uterine incision and 3 cm from the right lateral border. The mounted No. 2 absorbable suture is threaded through the uterine cavity to emerge at the upper incision margin 3 cm above and approximately 4 cm from the lateral border (because the uterus widens from below upwards). The absorbable suture now visible is passed over to compress the uterine fundus approximately 34 cm from the right cornual border. The absorbable suture is fed posteriorly and vertically to enter the posterior wall of the uterine cavity at the same level as the upper anterior entry point. The absorbable suture is pulled under moderate tension assisted by manual compression exerted by the first assistant. The length of the absorbable suture is passed back posteriorly through the same surface marking as for the right side, the suture lying horizontally. The absorbable suture is fed through posteriorly and vertically over the fundus to lie anteriorly and Research Template 7 Final Version: 1/6/2018 vertically compressing the fundus on the left side as occurred on the right. The needle is passed in the same fashion on the left side through the uterine cavity and out approximately 3 cm anteriorly and below the lower incision margin on the left side. The two lengths of absorbable suture are pulled taught assisted by bi-manual compression to minimize trauma and to achieve or aid compression. During such compression the vagina is checked that the bleeding is controlled. As good hemostasis is secured and whilst the uterus is compressed by an experienced assistant the principal surgeon throws a knot (double throw) followed by two or three further throws to secure tension. The lower transverse uterine incision is now closed in the normal way, in two layers, with or without closure of the lower uterine segment peritoneum. BALLOON INSERTION Insert the balloon portion of the catheter in the uterus; making certain that the entire balloon is inserted past the cervical canal and internal ostium. NOTE: Avoid excessive force when inserting the balloon into the uterus. Place a Foley catheter in patient bladder to collect and monitor urine output. To ensure maintenance of correct placement and maximize tamponade effect, the vaginal canal may be packed with iodine or antibiotic soaked vaginal gauze at this time.


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: 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: 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)
D: 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.)

Answer: C