Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage (NCT06968481) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage
Nigeria330 participantsStarted 2026-05-30
Plain-language summary
An open-label, randomized, single-center, dose ascending trial will be conducted to evaluate the efficacy and safety of sublingual oxytocin for the prevention of post-partum hemorrhage caused by uterine atony in term pregnant women having an uncomplicated vaginal delivery.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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Inclusion criteria
✓. Women willing and able to provide Informed consent.
✓. Women who are able to understand, confirm and give informed consent during an antenatal visit or first stage of labor (cervical dilation \<6 cm).
✓. Healthy, primiparous or multiparous (2-4 deliveries), term-pregnant female with a gestational age of 37 to 42 weeks (inclusive). Gestational age should be confirmed with an obstetrical ultrasound if available.
✓. Aged between 18 and 40 years (both inclusive).
✓. Confirmed singleton pregnancy.
✓. Based on the Investigator assessment, maternal and fetal conditions are met to expect a vaginal delivery.
✓. For participants in the PK subgroup: women with baseline hemoglobin level ≥11 g/dL.
Exclusion criteria
✕. Women who are unable to provide written Informed consent.
✕. Women undergoing an elective or emergency cesarean section.
✕. 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).
✕. Women with moderate or severe anemia (defined as Hb \<10 g/dL).
What they're measuring
1
Proportion of participants with a satisfactory uterine tone and cumulative blood loss < 500 ml
Timeframe: From administration of the drug to 20 minutes post-partum
✕. Women who have undergone female genital mutilation.
✕. Known allergies to carbetocin, other oxytocin homologues or excipients in the medicinal products used in the trial.
✕. Oral conditions before administration of sublingual oxytocin such as moderate erythema and edema, severe irritation/inflammation, moderate or severe abrasion.
✕. 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.