Please select the eligibility criteria that correspond to the clinical trial below.
Title: Double-blind Randomised Non-inferiority Trial to Assess Efficacy and Safety of Carbetocin After Caesarean Section Applied as Iv-bolus as Compared to a Short-infusion
Brief Summary: Postpartum haemorrhage (PPH) is an obstetric emergency and defined as a blood loss of ≥500ml after vaginal birth and ≥1000ml after caesarean section (CS) and/or the need for blood transfusion within 24 hours after delivery (World Health Organization, Recommendations for the Prevention of Postpartum Haemorrhage. 2007; Leduc et al., J Obstet Gynaecol Can, 2009). Since PPH is more common after caesarean deliveries than after vaginal births and the rate of CS is rising over time and will probably continue to rise, the incidence of PPH is expected to increase accordingly.

A meta-analysis has shown that routine administration of an oxytocic agent after caesarean delivery leads to a reduced blood loss and decreases the risk of PPH (Cotter et al., Cochrane Database Syst Rev, 2001). The two most commonly used oxytocic drugs after operative delivery are oxytocin and carbetocin, a synthetic oxytocin-analogue. Carbetocin has the advantage over oxytocin of having a longer half-life and therefore reducing the use of additional uterotonics. Based on the findings of reduced cardiovascular side-effects with a short-infusion as compared to a bolus injection found for oxytocin (Thomas et al., Br J Anaesth, 2007), our study hypothesis is that a slower administration rate of carbetocin minimises the cardiovascular side effects without compromising the uterine tone. Therefore, we aim to investigate a short infusion of carbetocin 100 mcg applied in 100ml sodium chlorid compared to a bolus application in women undergoing primary or secondary caesarean delivery. This prospective, double-blind, randomised controlled non-inferiority trial will take place at the University Hospital Basel, Switzerland. We hypothesize uterine contraction not to be inferior (primary efficacy endpoint) and the mean arterial pressure to be higher after a short-infusion than after a bolus administration (primary safety endpoint).


Options:
A: Inclusion Criteria:

* Healthy pregnant women undergoing elective caesarean section with regional anesthesia

Exclusion Criteria:

---Women with

* placenta praevia
* placental abruption
* multiple gestation
* pregnancy related complications and disorders (i.e. preeclampsia, gestational diabetes)
* pre-existing diseases (e.g. insulin-dependent diabetes, cardiovascular or renal diseases, thyroid disease
* taking medication with known impact on the cardiovascular system
* undergoing caesarean section with general anesthesia
* secondary caesarean section
B: Inclusion Criteria:

1. Age 18 years or more.
2. Gestational age of pregnancy of 37 completed weeks or more.
3. Written and signed informed consent by the patient to participate in the study.

Exclusion Criteria:

1. fetal or maternal distress where, due to time constraints, it will not possible and/or appropriate to recruit or randomize.
2. Women undergoing caesarean section with general anesthesia are also excluded, because carbetocin is licensed for use with regional anaesthesia only.
3. Women planned to have any other type of uterine incision other than transverse lower segment.
4. Women with HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), eclampsia, and epilepsy .
5. Women with placental abruption are excluded because there is a higher risk of hemorrhage with this condition and it was therefore felt to be inappropriate to recruit these women.
6. Women with thrombocytopenia, known coagulopathies, or receiving anticoagulant therapy.
7. Women with history of significant heart disease, a history or evidence of liver, renal, vascular disease or endocrine disease (other than gestational diabetes).
8. Women with history of hypersensitivity to oxytocin or carbetocin.
9. Women with any severe allergic condition or severe asthma.
10. Women with any contraindication to receiving prostaglandins, including known hypersensitivity to misoprostol or other prostaglandins (PGs) or glaucoma.
11. Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.
C: Inclusion Criteria:

* healthy women
* singleton pregnancy
* caesarean section under regional anaesthesia
* older than 18 years
* written informed consent

Exclusion Criteria:

* emergency caesarean section
* secondary caesarean section due to fetal distress
* comorbidities (cardiovascular, kidney or liver disorder, epilepsy)
* obstetric diseases (hypertension, (pre-)eclampsia)
* uterine malformation (including uterine fibroids)
* bleeding disorder
* known hypersensitivity to carbetocin or oxytocin
* fetal malformation
D: Inclusion Criteria:

* \> 24 weeks, viable pregnancy, singleton or twins

Exclusion Criteria:

* No consent
* Contraindication to oxytocin
* Antepartum fetal demise
* Intrapartum use of concentrated oxytocin
* Planned cesarean
* DIC or coagulopathy

Answer: C