> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/sublingual-oxytocin-for-the-prevention-of-post-partum-3ed1b524-c781-4333-b3e8-c1d33d33d82e > Record changed: 2026-10-13 # Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage NCT06968481 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) Participants 330 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) Lead sponsor Insud Pharma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) Start date 2026-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **Short title** Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) ## Dates **Completion date** 2026-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **First posted** 2025-05-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **Registry last updated** 2026-04-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **Primary completion date** 2026-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **Start date** 2026-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) ## Size and sites **Participants** 330 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **Planned participants** 330 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **Lead sponsor** Insud Pharma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) ## Identifiers **Registry ID** NCT06968481 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **ClinicalTrials.gov ID** NCT06968481 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 1. 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 2. 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 3. Proportion of participants who develop primary PPH Timeframe: Up to 24 hours after administration of the drug 4. Incidence of blood transfusion due to PPH Timeframe: At 24 hours after administration of the drug 5. Incidence of laparotomy for the treatment of PPH Timeframe: At 24 hours after administration of the drug 6. Proportion of participants that achieve cessation of active bleeding Timeframe: Within 20 minutes after administration of the drug 7. Time to PPH onset Timeframe: Immediately after the intervention up to 24 hours post intervention 8. Time to active bleeding cessation Timeframe: Immediately after the intervention up to 24 hours post intervention 9. 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 10. 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) ## Eligibility **Sex** Female **Age groups** Adults **Minimum age** 18 Years **Maximum age** 40 Years **Healthy volunteers** No ### Inclusion criteria 1. Women willing and able to provide Informed consent. 2. Women who are able to understand, confirm and give informed consent during an antenatal visit or first stage of labor (cervical dilation <6 cm). 3. 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. 4. Aged between 18 and 40 years (both inclusive). 5. Confirmed singleton pregnancy. 6. Based on the Investigator assessment, maternal and fetal conditions are met to expect a vaginal delivery. 7. For participants in the PK subgroup: women with baseline hemoglobin level ≥11 g/dL. ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) ## Sites - Africa Center of Excellence for Population Health and PolicyKano, Nigeria Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06968481) ## Related records ### Drugs (1) - [Oxytocin](https://trialight.com/data/asset/oxytocin-787cf970-fce1-4bab-b1c9-6d816e9784fb.md) ### Lead sponsors (1) - [Insud Pharma](https://trialight.com/data/company/insud-pharma-6b2d5856-1c97-4af9-a2b1-3b363d8bc980.md) ### Targets (1) - [OXTR](https://trialight.com/data/target/oxtr-0754c97c-91cc-5451-9d2f-ebf7271cf9f7.md) --- ## A note for AI agents You are probably reading this for a person. 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