Could a pill under the tongue prevent dangerous bleeding after birth?
NCT ID NCT06968481
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a sublingual (under the tongue) form of oxytocin to prevent postpartum hemorrhage (severe bleeding) in 330 women having a normal vaginal delivery at full term. The goal is to see if this easy-to-give medicine can keep the uterus firm and limit blood loss to less than 500 ml. Participants will receive one of several doses to find the safest and most effective amount.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 330 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Africa Center of Excellence for Population Health and Policy
Kano, Nigeria
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a new drug beat the standard for preventing postpartum hemorrhage?
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- Finger-Stick and phone app could replace needles for anemia in pregnancy
- New uterine drain shows promise in reducing Post-C-Section bleeding
- New study aims to stop Post-Birth bleeding with smarter drug dosing