Carbetocin vs Oxytocin for Postpartum Hemorrhage

Overseen By Mrinalini Balki, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Disqualifiers: Heart disease, Bleeding disorder, Anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Immediate perioperative period

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if carbetocin is more effective than oxytocin in preventing excessive bleeding after a cesarean delivery. It targets patients at higher risk of postpartum hemorrhage (PPH), such as those expecting twins, having a large baby, or experiencing conditions like excess amniotic fluid, high blood pressure, or diabetes. After delivery, participants will receive either carbetocin or oxytocin (a hormone used to induce labor) to assess which medication better reduces bleeding. This trial may suit those with these risk factors undergoing a cesarean delivery. As an unphased trial, it offers a unique opportunity to contribute to research that could improve outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on treatment for diabetes or preeclampsia, it seems you can continue those medications as they are part of the inclusion criteria.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both carbetocin and oxytocin are generally safe for preventing heavy bleeding after childbirth, known as postpartum hemorrhage (PPH). Studies have found that carbetocin is as safe as oxytocin and more effective in reducing the need for extra medication to control bleeding. In one study, about 1.51% of people using carbetocin and 1.45% using oxytocin experienced a specific outcome, indicating similar safety levels.

Oxytocin is often used during childbirth to prevent PPH and is considered safe, though it can sometimes cause side effects. It remains a standard treatment. Compared to oxytocin, carbetocin has caused fewer severe bleeding cases and reduced the need for additional treatments during cesarean deliveries. Both treatments have been well-tolerated in managing PPH. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about carbetocin for postpartum hemorrhage because it offers a potentially longer-lasting effect compared to the standard oxytocin treatment. Carbetocin is a synthetic version of oxytocin, but it has a longer half-life, meaning it stays active in the body longer and could reduce the need for continuous infusions. This could simplify the treatment process and provide more consistent control of bleeding after childbirth, potentially enhancing patient outcomes.

What evidence suggests that this trial's treatments could be effective for preventing postpartum hemorrhage?

This trial will compare Carbetocin and Oxytocin for preventing postpartum hemorrhage (PPH). Research has shown that both drugs effectively prevent heavy bleeding after childbirth. However, differences exist between them. Studies have found that carbetocin can reduce blood loss and the likelihood of PPH more effectively than oxytocin. It also typically results in fewer hospital visits related to PPH. Conversely, oxytocin effectively lowers the risk of PPH compared to no treatment, though some patients may require additional medication. Overall, carbetocin might be better for preventing PPH in high-risk cases, but oxytocin remains a strong option in many situations. ^{2 3 6 7 8}

Who Is on the Research Team?

Mrinalini Balki, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

This trial is for women at high risk of heavy bleeding after a cesarean delivery. Risk factors include having twins or more, a large baby, too much amniotic fluid, previous heavy bleeding after birth, obesity (BMI over 40), diabetes, high blood pressure, and placenta previa.

Inclusion Criteria

Any one or more of the risk factors for uterine atony: Overdistended uterus due to polyhydramnios (amniotic fluid index >24 cm), fetal macrosomia reported on prenatal ultrasound >90th centile or > 4000 gm, multiple gestation, history of uterine atony/PPH (documented with blood loss of >1000 ml, blood transfusion, use of surgical methods such as Bakri balloon, B-Lynch sutures, uterine artery ligation or embolization), obesity with body mass index (BMI) >40 kg/m2, diabetes mellitus, hypertensive disease (chronic hypertension or severe preeclampsia on treatment), placenta previa

Exclusion Criteria

Placenta accreta spectrum

I have a bleeding disorder.

Anemia (<100 g/dl)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either carbetocin or oxytocin during cesarean delivery to prevent postpartum hemorrhage

Immediate perioperative period

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of blood loss and uterine tone

24 hours

1 visit (in-person)

Long-term follow-up

Participants are monitored for any long-term effects or complications post-delivery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Carbetocin
• Oxytocin

Trial Overview The study compares two drugs used to prevent excessive bleeding post-cesarean: oxytocin and carbetocin. It specifically looks at their effectiveness in women with higher chances of postpartum hemorrhage due to certain health conditions.

How Is the Trial Designed?

Group I: Oxytocin 5IU Active Control 1 Intervention

IV oxytocin 5 IU diluted in 10 mL normal saline over 1 min followed by continuous infusion of 250 mIU/min over 4 hours.

Group II: Carbetocin 100mcg Active Control 1 Intervention

IV carbetocin 100 mcg diluted in 10 mL normal saline over 1 min followed by placebo infusion for 4 hours after the delivery of the fetus.

Who Is Running the Clinical Trial?

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Lead Sponsor

Trials

132

Recruited

11,400+

Published Research Related to This Trial

Carbetocin was found to be more effective than oxytocin in preventing postpartum hemorrhage (PPH) after cesarean sections, as it significantly reduced the need for additional uterotonics (75% for oxytocin vs. 33% for carbetocin).

Patients with a higher pre-pregnancy BMI (≥25) required more additional treatment after receiving carbetocin compared to oxytocin, indicating that further research is needed to understand the effects of BMI on treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of carbetocin and oxytocin effectiveness for prevention of postpartum hemorrhage after caesarean delivery]. Brzozowska, M., Lisiecki, D., Kowalska-Koprek, U., et al.[2019]

Carbetocin significantly reduced postpartum hemorrhage (PPH) compared to oxytocin, with lower bleeding amounts (337.73 mL vs. 378 mL) and a lower occurrence of PPH (4% vs. 16%) in a study of 200 women.

Carbetocin also resulted in better hemoglobin levels post-delivery and caused fewer hemodynamic changes, making it a safer alternative to oxytocin, despite a higher incidence of tachycardia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbetocin versus oxytocin for prevention of postpartum hemorrhage after vaginal delivery in high risk women. Maged, AM., Hassan, AM., Shehata, NA.[2023]

Carbetocin significantly reduces the need for additional uterotonic agents compared to oxytocin in women after cesarean delivery, indicating its efficacy in preventing postpartum hemorrhage.

Carbetocin has a lower risk of adverse effects compared to syntometrine during vaginal delivery, making it a potentially safer alternative for preventing postpartum hemorrhage, with similar effectiveness to other uterotonics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbetocin for the prevention of postpartum hemorrhage: a systematic review and meta-analysis of randomized controlled trials. Jin, B., Du, Y., Zhang, F., et al.[2022]

In a study of 100 women, carbetocin was found to be more effective than oxytocin in reducing blood loss and the need for additional uterotonics during the management of atonic postpartum hemorrhage after vaginal delivery.

Both carbetocin and oxytocin showed similar safety profiles, with no significant differences in side effects or hemodynamic changes, suggesting that carbetocin is a safer alternative for treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbetocin versus oxytocin in the management of atonic post partum haemorrhage (PPH) after vaginal delivery: a randomised controlled trial. Maged, AM., Hassan, AM., Shehata, NA.[2018]

Carbetocin is likely as effective as oxytocin and syntometrine in preventing postpartum hemorrhage, based on a review of various studies that assessed multiple outcome measures.

The safety profile of carbetocin is similar to that of oxytocin, which is currently the standard treatment for this condition, although further research is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbetocin for the prevention of postpartum hemorrhage: a systematic review. Peters, NC., Duvekot, JJ.[2018]

In a study of 160 hypertensive pregnant women undergoing cesarean section, carbetocin was found to significantly reduce postoperative blood loss compared to oxytocin, with blood loss averaging 424.75 ml in the carbetocin group versus 679.5 ml in the oxytocin group.

Carbetocin also maintained hemoglobin levels post-delivery, while oxytocin led to a significant decrease in hemoglobin, indicating that carbetocin may be a safer option for preventing postpartum hemorrhage in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbetocin versus oxytocin for prevention of postpartum hemorrhage in hypertensive women undergoing elective cesarean section. Ibrahim, ZM., Sayed Ahmed, WA., Abd El-Hamid, EM., et al.[2021]

In a clinical trial involving 110 women undergoing elective cesarean sections, a single dose of carbetocin was found to be effective in maintaining uterine tone and reducing postpartum hemorrhage compared to oxytocin.

Carbetocin not only reduced the need for analgesic medications and postoperative pain significantly on the day of surgery and the following days, but it also improved the overall quality of life for the women in the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbetocin versus oxytocin after caesarean section: similar efficacy but reduced pain perception in women with high risk of postpartum haemorrhage. De Bonis, M., Torricelli, M., Leoni, L., et al.[2012]

In a study involving 350 women at high risk for postpartum hemorrhage, intravenous carbetocin significantly reduced postpartum blood loss compared to intravenous oxytocin (146.7 mL vs. 195.1 mL) and completely prevented atonic PPH, while oxytocin had a 6.3% incidence of this condition.

Carbetocin also led to lower usage of additional uterotonic drugs and a reduced incidence of postpartum anemia, with no significant differences in side effects between the two treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous carbetocin versus intravenous oxytocin for preventing atonic postpartum hemorrhage after normal vaginal delivery in high-risk singleton pregnancies: a triple-blind randomized controlled trial. Amornpetchakul, P., Lertbunnaphong, T., Boriboonhiransarn, D., et al.[2019]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK546425/

Carbetocin for the Prevention of Post-Partum Hemorrhage In the primary studies, carbetocin was associated with similar or more effectiveness regarding the prevention of PPH, reducing additional ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0279130

Cost-effectiveness analysis of carbetocin for prevention of ... In base-case analysis, carbetocin (versus oxytocin) reduced PPH-related cost (by USD29 per birth), PPH ≥500 mL and ≥1,500 mL (by 13.7 and 1.9 per 1,000 births), ...

3. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.18358

Carbetocin for Postpartum Haemorrhage Prophylaxis in All ... Carbetocin is associated with reduced blood loss and the rate of PPH compared to Oxytocin. Associated reductions in admissions to high ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1805489

Heat-Stable Carbetocin versus Oxytocin to Prevent ... However, in our trial, this outcome occurred in 1.51% of the participants in the carbetocin group and in 1.45% of those in the oxytocin group.

5. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-023-09263-4

Cost-effectiveness and budget impact of heat-stable ... Compared to oxytocin, heat-stable carbetocin avoided 5,468 additional PPH events, 5 deaths, and 244 DALYs per 100,000 births. Projected direct ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40890901/

Carbetocin for Postpartum Haemorrhage Prophylaxis in All ... Results: Carbetocin was associated with significantly lower average blood loss (p < 0.001), including rates of moderate and severe PPH (p < ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35243717/

Effectiveness and safety of carboxytocin versus oxytocin in ... For patients undergoing cesarean section and vaginal delivery, carbetocin was superior to oxytocin in effectiveness and similar in safety.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1028455918300688

Carbetocin versus oxytocin for the prevention of ... Carbetocin is effective in reducing the use of additional uterotonics, reduction in postpartum hemorrhage and transfusion when used during cesarean deliveries.