Post Partum HemorrhagePhase 2NCT06968481
Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage
A Phase 2 study testing Oxytocin sublingual and Oxytocin IM in people with Post Partum Hemorrhage, run by Insud Pharma at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- Oxytocin sublingual and Oxytocin IM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteNigeria
- Study dates
- 30 May 2026to 30 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nigeria1 site
Africa Center of Excellence for Population Health and Policy
Kano
Hadiza Shedu Galadanci, +234 803 321 0047, dir.acephap@buk.edu.ng
About this study
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
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.
Read the detailed description
The primary objective is to estimate the optimal effective dose (ED90) of sublingual oxytocin administered during the active management of the third stage of labor to result in satisfactory uterine tone and a cumulative blood loss < 500 ml at 20 minutes after vaginal delivery in 90% of parturients with an acceptable safety profile.
- Conditions
- Post Partum Hemorrhage
- Being tested
- Oxytocin sublingual, Oxytocin IM
- Keywords
- sublingual oxytocin, oxytocin, post-partum hemorrhage, severe post-partum hemorrhage, SPPH, Prevention of post-partum hemorrhage, Efficacy and safety
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin sublingualDrug
Also called oxytocin investigational drug
Sublingual oxytocin 1000 IU, 3000 IU or 6000 IU
Oxytocin IMDrug
Also called oxytocin standard therapy
Intramuscular oxytocin 10 IU
| Study group | Role | What they receive |
|---|---|---|
| Sublingual Oxytocin | Experimental | sublingual administration of oxytocin Receives: Drug: Oxytocin sublingual |
| Intramuscular Oxytocin | Other | Reference product is intramuscular administration of oxytocin Receives: Drug: Oxytocin IM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with a satisfactory uterine tone and cumulative blood loss < 500 ml
Measured: From administration of the drug to 20 minutes post-partum
Secondary outcomes (10)
Proportion of participants with satisfactory uterine tone
Measured: 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
Measured: 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
Measured: Up to 24 hours after administration of the drug
Incidence of blood transfusion due to PPH
Measured: At 24 hours after administration of the drug
Incidence of laparotomy for the treatment of PPH
Measured: At 24 hours after administration of the drug
Proportion of participants that achieve cessation of active bleeding
Measured: Within 20 minutes after administration of the drug
Time to PPH onset
Measured: Immediately after the intervention up to 24 hours post intervention
Time to active bleeding cessation
Measured: Immediately after the intervention up to 24 hours post intervention
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start30 May 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insud Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enrico Colli, MD, Study director, Chemo Research SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968481
- Sponsor's protocol ID
- EX005-201
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06968481
- Acronym / sponsor ID
- EX005-201
- Conditions
- Post Partum Hemorrhage
- Keywords
- sublingual oxytocin, oxytocin, post-partum hemorrhage, severe post-partum hemorrhage, SPPH, Prevention of post-partum hemorrhage, Efficacy and safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Insud PharmaIndustry (pharma, biotech, devices)
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective is to estimate the optimal effective dose (ED90) of sublingual oxytocin administered during the active management of the third stage of labor to result in satisfactory uterine tone and a cumulative blood loss < 500 ml at 20 minutes after vaginal delivery in 90% of parturients with an acceptable safety profile.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublingual Oxytocin | Experimental | Drug: Oxytocin sublingualsublingual administration of oxytocin |
| Intramuscular Oxytocin | Other | Drug: Oxytocin IMReference product is intramuscular administration of oxytocin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin sublingualAlso: oxytocin investigational drugSublingual oxytocin 1000 IU, 3000 IU or 6000 IU | Drug | Sublingual Oxytocin |
| Oxytocin IMAlso: oxytocin standard therapyIntramuscular oxytocin 10 IU | Drug | Intramuscular Oxytocin |
Primary outcome
Proportion of participants with a satisfactory uterine tone and cumulative blood loss < 500 ml
Time frame: From administration of the drug to 20 minutes post-partum
10 secondary outcomes
Proportion of participants with satisfactory uterine tone
Time frame: 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
Time frame: 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
Time frame: Up to 24 hours after administration of the drug
Incidence of blood transfusion due to PPH
Time frame: At 24 hours after administration of the drug
Incidence of laparotomy for the treatment of PPH
Time frame: At 24 hours after administration of the drug
Proportion of participants that achieve cessation of active bleeding
Time frame: Within 20 minutes after administration of the drug
Time to PPH onset
Time frame: Immediately after the intervention up to 24 hours post intervention
Time to active bleeding cessation
Time frame: Immediately after the intervention up to 24 hours post intervention
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Related trials for Post Partum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Enrico Colli, MD study director
Chemo Research SL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin sublingual and Oxytocin IM in people with Post Partum Hemorrhage, run by Insud Pharma at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alicyoy Angulo, MD (+34 676 943 642, Alicyoy.angulo@external.chemogroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with a satisfactory uterine tone and cumulative blood loss < 500 ml (time frame: From administration of the drug to 20 minutes post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.