Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage
- 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.
- Short title
- Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage
- Official title
- Phase 2, Open-label, Randomized, Dose Ascending Trial to Evaluate the Efficacy and Safety of Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage Caused by Uterine Atony in Term Pregnant Women With Uncomplicated Vaginal Delivery
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2026-10-30
- First posted
- 2025-05-13
- Registry last updated
- 2026-04-23
- Primary completion date
- 2026-10-30
- Start date
- 2026-05-30
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Insud Pharma
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06968481
- ClinicalTrials.gov ID
- NCT06968481
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- No masking
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
Proportion of participants with satisfactory uterine tone
Timeframe: after 3 min, 5 min, 10 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 12 hours and 24 hours after administration of the drug
Measurement of blood loss
Timeframe: 3 min, 5 min, 10 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 12 hours and 24 hours after administration of the drug
Proportion of participants who develop primary PPH
Timeframe: Up to 24 hours after administration of the drug
Incidence of blood transfusion due to PPH
Timeframe: At 24 hours after administration of the drug
Incidence of laparotomy for the treatment of PPH
Timeframe: At 24 hours after administration of the drug
Proportion of participants that achieve cessation of active bleeding
Timeframe: Within 20 minutes after administration of the drug
Time to PPH onset
Timeframe: Immediately after the intervention up to 24 hours post intervention
Time to active bleeding cessation
Timeframe: Immediately after the intervention up to 24 hours post intervention
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From the time of written informed consent until the End of Study visit and must be followed up until resolution or stabilization
Absolute number and percentage of participants with oral irritation/inflammation and abrasion
Timeframe: after admission to hospital (during the Latent or Active phase for all participants) and at 20 minutes and 24 hours post dose for participants who are administered the investigational drug
- Sex
- Female
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 40 Years
- Healthy volunteers
- No
- 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.
- 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).
- 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.
- 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).
- Previous surgery of the cervix or uterus or any other preexisting condition that could interfere with the measurement of uterine contractility.
- Current use or use within 30 days before the start of the IMP or reference product of one or more of predefined medications
- Africa Center of Excellence for Population Health and PolicyKano, Nigeria