Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage

NCT06968481 | Not Yet Recruiting Phase 2

• 1 other identifier: EX005-201
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Partum Hemorrhage

Keywords

sublingual oxytocin; oxytocin; post-partum hemorrhage; severe post-partum hemorrhage; SPPH; Prevention of post-partum hemorrhage; Efficacy and safety

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with a satisfactory uterine tone and cumulative blood loss < 500 ml

  From administration of the drug to 20 minutes post-partum

Secondary Outcomes (10)

• Proportion of participants with satisfactory uterine tone

  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

  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

  Up to 24 hours after administration of the drug

• Incidence of blood transfusion due to PPH

  At 24 hours after administration of the drug

• Incidence of laparotomy for the treatment of PPH

  At 24 hours after administration of the drug

Study Arms (2)

Sublingual Oxytocin

EXPERIMENTAL

sublingual administration of oxytocin

Drug: Oxytocin sublingual

Intramuscular Oxytocin

OTHER

Reference product is intramuscular administration of oxytocin

Drug: Oxytocin IM

Interventions

Oxytocin sublingual DRUG

Sublingual oxytocin 1000 IU, 3000 IU or 6000 IU

Also known as: oxytocin investigational drug

Sublingual Oxytocin

Oxytocin IM DRUG

Intramuscular oxytocin 10 IU

Also known as: oxytocin standard therapy

Intramuscular Oxytocin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Insud Pharma: lead

Study Sites (1)

Africa Center of Excellence for Population Health and Policy

Kano, Nigeria

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Enrico Colli, MD

  Chemo Research SL

  STUDY DIRECTOR

Central Study Contacts

Alicyoy Angulo, MD

CONTACT

+34 676 943 642; Alicyoy.angulo@external.chemogroup.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: May 13, 2025
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

NG (1)