Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage

Exclusion Criteria

• •1. Women who are unable to provide written Informed consent.
• •2. Women undergoing an elective or emergency cesarean section.
• •3. Conditions predisposing to uterine atony and PPH (e.g., previous PPH, placenta praevia, multiple gestation, severe pre-eclampsia, polyhydramnios, uterine fibroids, need for induction of labor, bleeding diathesis, sepsis, body mass index \[BMI\] ˃ 30 kg/m2 , macrosomia with estimated fetal weight \>4500 g, if antenatal ultrasound was performed).
• •4. Women with moderate or severe anemia (defined as Hb \<10 g/dL).
• •5. Women who have undergone female genital mutilation.
• •6. Known allergies to carbetocin, other oxytocin homologues or excipients in the medicinal products used in the trial.
• •7. Oral conditions before administration of sublingual oxytocin such as moderate erythema and edema, severe irritation/inflammation, moderate or severe abrasion.
• •8. Conditions predisposing to myocardial ischemia due to pre-existing cardiovascular diseases (such as hypertrophic cardiomyopathy, valvular heart disease and/or ischemic heart disease, including vasospasm of the coronary arteries) or known long QT syndrome or related symptoms.
• •9. Any clinically significant abnormality following review of medical history, laboratory result and physical examination at screening as judged by the Investigator (e.g., severe anemia, antepartum hemorrhage, mental disorder, history of cervical cancer or history of severe infection of the uterus, religious beliefs prohibiting blood transfusions).
• •10. Previous surgery of the cervix or uterus or any other preexisting condition that could interfere with the measurement of uterine contractility.
• •11. Current use or use within 30 days before the start of the IMP or reference product of one or more of predefined medications