Postpartum ComplicationNCT07353281
Carbetocin vs Misoprostol for Postpartum Hemorrhage Prevention
A study testing Carbetocin 100 Microgram/mL Solution for Injection and Misoprostol in people with Postpartum Complication and Postpartum Hemorrhage, run by Western Galilee Hospital-Nahariya.
Trial summary
Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide, particularly among women with known risk factors. Uterotonic agents are routinely administered after vaginal delivery to prevent excessive bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Complication, Postpartum Hemorrhage
- What is being tested?
- Carbetocin 100 Microgram/mL Solution for Injection and Misoprostol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2026to 1 Jan 2028
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 years or older
- Singleton pregnancy
- Gestational age 37-42 weeks
- Cephalic presentation
- Vaginal delivery
- Presence of one or more risk factors for postpartum hemorrhage, including:
Show all 15Show fewer
- Grand multiparity (≥5 previous deliveries)
- History of postpartum hemorrhage
- History of manual removal of placenta
- Estimated fetal weight ≥4,000 grams
- Polyhydramnios
- Chorioamnionitis
- Prolonged oxytocin use during labor (third augmentation cycle or more)
- Eligible for prophylactic uterotonic therapy after delivery
- Provided written informed consent
Who cannot join
- Multiple gestation
- Known major fetal anomalies
- Intrauterine fetal demise (IUFD)
- Contraindication to vaginal delivery
- Known hypersensitivity to carbetocin, misoprostol, or oxytocin
- Known coagulation disorders requiring alternative management
- Planned cesarean delivery
- Participation in another interventional study that may affect postpartum bleeding outcomes
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Carbetocin Versus Misoprostol for the Prevention of Postpartum Hemorrhage After Vaginal Delivery in Women With Risk Factors: A Prospective Randomized Study
Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide, particularly among women with known risk factors. Uterotonic agents are routinely administered after vaginal delivery to prevent excessive bleeding. Carbetocin, a long-acting oxytocin analogue, and misoprostol are both used for this purpose, but comparative data in high-risk vaginal deliveries remain limited.
This prospective randomized study aims to compare the effectiveness and safety of intravenous carbetocin versus rectal misoprostol for the prevention of postpartum hemorrhage in women with risk factors undergoing vaginal delivery at Galilee Medical Center. The primary outcome is the incidence of postpartum hemorrhage. Secondary outcomes include the need for additional uterotonic agents or surgical interventions, changes in hemoglobin levels, blood transfusion requirements, and maternal adverse effects.
Read the detailed description
Postpartum hemorrhage (PPH), most commonly caused by uterine atony, remains a major contributor to maternal morbidity and mortality. Women with established risk factors-such as grand multiparity, prior PPH, prolonged labor, fetal macrosomia, polyhydramnios, chorioamnionitis, or prolonged oxytocin exposure-are at particularly increased risk following vaginal delivery.
Active management of the third stage of labor using uterotonic medications is the cornerstone of PPH prevention. Oxytocin is widely used but has a short half-life, often requiring repeated dosing or continuous infusion. Carbetocin is a synthetic oxytocin analogue with a longer half-life and sustained uterotonic effect, which may offer improved prophylaxis against PPH. Misoprostol, a prostaglandin E1 analogue, is also commonly used due to its low cost, ease of administration, and stability, although it is associated with gastrointestinal and thermoregulatory side effects.
While carbetocin has demonstrated superiority over oxytocin in cesarean deliveries, evidence comparing carbetocin with misoprostol in high-risk vaginal deliveries is limited. This prospective, randomized, single-center study will enroll women at term with singleton pregnancies and predefined risk factors for postpartum hemorrhage. Participants will be randomized in a 1:1 ratio to receive either intravenous carbetocin (100 µg) or rectal misoprostol (1000 µg) with standard oxytocin after placental delivery.
The primary outcome is the occurrence of postpartum hemorrhage. Secondary outcomes include the need for additional uterotonic agents, blood transfusion, uterine revision or manual placental removal, changes in hemoglobin levels before and after delivery, duration of maternal hospitalization, and maternal adverse effects such as diarrhea, shivering, headache, and facial flushing.
This study aims to provide high-quality prospective data to guide the optimal prophylactic uterotonic strategy for women at increased risk of postpartum hemorrhage following vaginal delivery.
- Conditions
- Postpartum Complication, Postpartum Hemorrhage
- Being tested
- Carbetocin 100 Microgram/mL Solution for Injection, Misoprostol
- Keywords
- Postpartum hemorrhage, Carbetocin, Misoprostol, Vaginal delivery, Uterotonic agents, High-risk pregnancy
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbetocin 100 Microgram/mL Solution for InjectionDrug
Participants randomized to this intervention will receive intravenous carbetocin 100 micrograms administered immediately after placental delivery as prophylaxis for postpartum hemorrhage following vaginal delivery. Carbetocin is a long-acting synthetic analogue of oxytocin and is used as part of active management of the third stage of labor in women at increased risk for postpartum hemorrhage.
MisoprostolDrug
Participants randomized to this intervention will receive rectal misoprostol 1000 micrograms immediately after placental delivery for the prevention of postpartum hemorrhage following vaginal delivery. In accordance with standard practice, intravenous oxytocin 10 units will also be administered as part of active management of the third stage of labor in women at increased risk for postpartum hemorrhage.
| Study group | Role | What they receive |
|---|---|---|
| Carbetocin arm | Experimental | Participants in this arm will receive intravenous carbetocin (100 micrograms) immediately after placental delivery for the prevention of postpartum hemorrhage following vaginal delivery. Carbetocin will be administered as part of active management of the third stage of labor in women at increased risk for postpartum hemorrhage. Receives: Drug: Carbetocin 100 Microgram/mL Solution for Injection |
| Misoprostol arm | Active comparator | Participants in this arm will receive rectal misoprostol (1000 micrograms) immediately after placental delivery, in addition to intravenous oxytocin, for the prevention of postpartum hemorrhage following vaginal delivery. This regimen represents an accepted uterotonic prophylaxis strategy for women at increased risk for postpartum hemorrhage. Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum hemorrhage (PPH)
Postpartum hemorrhage defined as estimated blood loss ≥1,000 mL within 24 hours after vaginal delivery, or any bleeding associated with hemodynamic instability requiring medical or surgical intervention, according to institutional protocol.
Measured: Within 24 hours after delivery
Need for additional uterotonic treatment or surgical intervention
Requirement for additional uterotonic agents (including oxytocin infusion, methylergonovine, carboprost, or misoprostol), uterine massage, uterine revision, or surgical intervention for management of postpartum bleeding.
Measured: Within 24 hours of delivery
Secondary outcomes (3)
Change in hemoglobin level
Difference between pre-delivery and post-delivery hemoglobin concentration, measured in g/dL.
Measured: From admission to 24-48 hours postpartum
Blood transfusion requirement
Administration of packed red blood cells or other blood products during or after delivery.
Measured: Up to 24-48 hours postpartum
Maternal adverse effects related to study medications
Occurrence of maternal side effects including diarrhea, shivering, headache, facial flushing, nausea, or vomiting following administration of study medications.
Measured: Within 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start31 Jan 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postpartum ComplicationStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Raneen Abu Shqara, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353281
- Sponsor's protocol ID
- 0206-25-NHR
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albazee E, Alrashidi H, Laqwer R, Elmokid SR, Alghamdi WA, Almahmood H, AlGhareeb M, Alfertaj N, Alkandari DI, AlDabbous F, Alkanderi J, Al-Jundy H, Abu-Zaid A, Alomar O. Intravenous Carbetocin Versus Rectal Misoprostol for the Active Management of the Third Stage of Labor: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cureus. 2022 Oct 12;14(10):e30229. doi: 10.7759/cureus.30229. eCollection 2022 Oct.
PubMed 36246091Delavallade M, Vaunois A, Cellier M, Boukerfa-Bennacer Y, Chauleur C, Raia-Barjat T. Carbetocin versus oxytocin for the prevention of postpartum haemorrhage during caesarean section in patients at high risk of bleeding. Eur J Obstet Gynecol Reprod Biol. 2024 Sep;300:206-210. doi: 10.1016/j.ejogrb.2024.07.015. Epub 2024 Jul 8.
PubMed 39029242Rath W. Prevention of postpartum haemorrhage with the oxytocin analogue carbetocin. Eur J Obstet Gynecol Reprod Biol. 2009 Nov;147(1):15-20. doi: 10.1016/j.ejogrb.2009.06.018. Epub 2009 Jul 17.
PubMed 19616358Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.
PubMed 28937571
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbetocin Versus Misoprostol for the Prevention of Postpartum Hemorrhage After Vaginal Delivery in Women With Risk Factors: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07353281
- Acronym / sponsor ID
- 0206-25-NHR
- Conditions
- Postpartum Complication, Postpartum Hemorrhage
- Keywords
- Postpartum hemorrhage, Carbetocin, Misoprostol, Vaginal delivery, Uterotonic agents, High-risk pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 20 Jan 2026 (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.
Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide, particularly among women with known risk factors. Uterotonic agents are routinely administered after vaginal delivery to prevent excessive bleeding. Carbetocin, a long-acting oxytocin analogue, and misoprostol are both used for this purpose, but comparative data in high-risk vaginal deliveries remain limited.
This prospective randomized study aims to compare the effectiveness and safety of intravenous carbetocin versus rectal misoprostol for the prevention of postpartum hemorrhage in women with risk factors undergoing vaginal delivery at Galilee Medical Center. The primary outcome is the incidence of postpartum hemorrhage. Secondary outcomes include the need for additional uterotonic agents or surgical interventions, changes in hemoglobin levels, blood transfusion requirements, and maternal adverse effects.
Detailed description
Postpartum hemorrhage (PPH), most commonly caused by uterine atony, remains a major contributor to maternal morbidity and mortality. Women with established risk factors-such as grand multiparity, prior PPH, prolonged labor, fetal macrosomia, polyhydramnios, chorioamnionitis, or prolonged oxytocin exposure-are at particularly increased risk following vaginal delivery.
Active management of the third stage of labor using uterotonic medications is the cornerstone of PPH prevention. Oxytocin is widely used but has a short half-life, often requiring repeated dosing or continuous infusion. Carbetocin is a synthetic oxytocin analogue with a longer half-life and sustained uterotonic effect, which may offer improved prophylaxis against PPH. Misoprostol, a prostaglandin E1 analogue, is also commonly used due to its low cost, ease of administration, and stability, although it is associated with gastrointestinal and thermoregulatory side effects.
While carbetocin has demonstrated superiority over oxytocin in cesarean deliveries, evidence comparing carbetocin with misoprostol in high-risk vaginal deliveries is limited. This prospective, randomized, single-center study will enroll women at term with singleton pregnancies and predefined risk factors for postpartum hemorrhage. Participants will be randomized in a 1:1 ratio to receive either intravenous carbetocin (100 µg) or rectal misoprostol (1000 µg) with standard oxytocin after placental delivery.
The primary outcome is the occurrence of postpartum hemorrhage. Secondary outcomes include the need for additional uterotonic agents, blood transfusion, uterine revision or manual placental removal, changes in hemoglobin levels before and after delivery, duration of maternal hospitalization, and maternal adverse effects such as diarrhea, shivering, headache, and facial flushing.
This study aims to provide high-quality prospective data to guide the optimal prophylactic uterotonic strategy for women at increased risk of postpartum hemorrhage following vaginal delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbetocin arm | Experimental | Drug: Carbetocin 100 Microgram/mL Solution for InjectionParticipants in this arm will receive intravenous carbetocin (100 micrograms) immediately after placental delivery for the prevention of postpartum hemorrhage following vaginal delivery. Carbetocin will be administered as part of active management of the third stage of labor in women at increased risk for postpartum hemorrhage. |
| Misoprostol arm | Active comparator | Drug: MisoprostolParticipants in this arm will receive rectal misoprostol (1000 micrograms) immediately after placental delivery, in addition to intravenous oxytocin, for the prevention of postpartum hemorrhage following vaginal delivery. This regimen represents an accepted uterotonic prophylaxis strategy for women at increased risk for postpartum hemorrhage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Women aged 18 years or older
- Singleton pregnancy
- Gestational age 37-42 weeks
- Cephalic presentation
- Vaginal delivery
Key exclusion criteria (8 listed)
- Multiple gestation
- Known major fetal anomalies
- Intrauterine fetal demise (IUFD)
- Contraindication to vaginal delivery
- Known hypersensitivity to carbetocin, misoprostol, or oxytocin
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 |
|---|---|---|
| Carbetocin 100 Microgram/mL Solution for InjectionParticipants randomized to this intervention will receive intravenous carbetocin 100 micrograms administered immediately after placental delivery as prophylaxis for postpartum hemorrhage following vaginal delivery. Carbetocin is a long-acting synthetic analogue of oxytocin and is used as part of active management of the third stage of labor in women at increased risk for postpartum hemorrhage. | Drug | Carbetocin arm |
| MisoprostolParticipants randomized to this intervention will receive rectal misoprostol 1000 micrograms immediately after placental delivery for the prevention of postpartum hemorrhage following vaginal delivery. In accordance with standard practice, intravenous oxytocin 10 units will also be administered as part of active management of the third stage of labor in women at increased risk for postpartum hemorrhage. | Drug | Misoprostol arm |
Primary outcome
Postpartum hemorrhage (PPH)
Time frame: Within 24 hours after delivery
Postpartum hemorrhage defined as estimated blood loss ≥1,000 mL within 24 hours after vaginal delivery, or any bleeding associated with hemodynamic instability requiring medical or surgical intervention, according to institutional protocol.
Need for additional uterotonic treatment or surgical intervention
Time frame: Within 24 hours of delivery
Requirement for additional uterotonic agents (including oxytocin infusion, methylergonovine, carboprost, or misoprostol), uterine massage, uterine revision, or surgical intervention for management of postpartum bleeding.
3 secondary outcomes
Change in hemoglobin level
Time frame: From admission to 24-48 hours postpartum
Blood transfusion requirement
Time frame: Up to 24-48 hours postpartum
Maternal adverse effects related to study medications
Time frame: Within 24 hours after delivery
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 20 Jan 2026.
- Results publication: PubMed 36246091Albazee E, Alrashidi H, Laqwer R, Elmokid SR, Alghamdi WA, Almahmood H, AlGhareeb M, Alfertaj N, Alkandari DI, AlDabbous F, Alkanderi J, Al-Jundy H, Abu-Zaid A, Alomar O. Intravenous Carbetocin Versus Rectal Misoprostol for the Active Management of the Third Stage of Labor: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cureus. 2022 Oct 12;14(10):e30229. doi: 10.7759/cureus.30229. eCollection 2022 Oct.
- Results publication: PubMed 39029242Delavallade M, Vaunois A, Cellier M, Boukerfa-Bennacer Y, Chauleur C, Raia-Barjat T. Carbetocin versus oxytocin for the prevention of postpartum haemorrhage during caesarean section in patients at high risk of bleeding. Eur J Obstet Gynecol Reprod Biol. 2024 Sep;300:206-210. doi: 10.1016/j.ejogrb.2024.07.015. Epub 2024 Jul 8.
- Results publication: PubMed 19616358Rath W. Prevention of postpartum haemorrhage with the oxytocin analogue carbetocin. Eur J Obstet Gynecol Reprod Biol. 2009 Nov;147(1):15-20. doi: 10.1016/j.ejogrb.2009.06.018. Epub 2009 Jul 17.
- Results publication: PubMed 28937571Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Carbetocin 100 Microgram/mL Solution for Injection and Misoprostol in people with Postpartum Complication and Postpartum Hemorrhage, run by Western Galilee Hospital-Nahariya.
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 15 inclusion and 8 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 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Nadir Ganem, Dr. (04-910-7107, nadirg@gmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum hemorrhage (PPH) (time frame: Within 24 hours after delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07353281, which also lists 4 linked publications.
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 20 Jan 2026.