Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage
ConditionPost Partum Hemorrhage
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorInsud Pharma
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Oxytocin sublingual
- Oxytocin IM
Treatment groups
330 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov