#1 Clinical Trials Search in Europe

Carbetocin

Carbetocin, a synthetic analogue of oxytocin, has been the subject of numerous clinical trials investigating its efficacy in preventing postpartum hemorrhage and other medical conditions. This article explores the various studies conducted on carbetocin, focusing on its use in obstetrics, particularly during cesarean deliveries, as well as its potential applications in other areas of medicine.

Table of Contents

What is Carbetocin?

Carbetocin is a medication used primarily in obstetrics, the branch of medicine dealing with childbirth. It is a synthetic analogue of oxytocin, which means it’s an artificially created version of a hormone naturally produced in the body[2]. Carbetocin is also known by other names such as Duratocin, Pabal, and ACP-101[1][3].

Uses of Carbetocin

Carbetocin is primarily used to prevent and treat a condition called postpartum hemorrhage (PPH). PPH is excessive bleeding after childbirth and is a major cause of maternal death worldwide[2]. The main uses of carbetocin include:

  • Preventing uterine atony (poor muscle tone of the uterus) after cesarean section deliveries[4]
  • Managing the third stage of labor (the period after the baby is born until the placenta is delivered) in women at low risk of PPH[1]
  • Promoting uterine contraction after vaginal or cesarean deliveries[2]

In addition to its use in obstetrics, carbetocin is also being studied for other conditions. For example, it’s being researched as a potential treatment for hyperphagia (excessive hunger) in people with Prader-Willi Syndrome, a rare genetic disorder[3].

How Carbetocin Works

Carbetocin works in a similar way to oxytocin, a hormone naturally produced in the body. It causes the uterus to contract, which is crucial after childbirth to prevent excessive bleeding. The key difference is that carbetocin lasts 4 to 7 times longer than oxytocin in the body, which means it can provide a more sustained effect[2].

Administration and Dosage

Carbetocin is typically administered in the following ways:

  • As an intravenous (IV) injection, usually given over 1 minute immediately after the delivery of the baby[2]
  • As a nasal spray in some research settings[3]

The dosage of carbetocin can vary. While the Society of Obstetricians and Gynecologists of Canada (SOGC) has recommended a single 100 microgram (mcg) dose, research is ongoing to determine if lower doses might be equally effective with fewer side effects[5].

Effectiveness

Studies have shown that carbetocin is effective in preventing postpartum hemorrhage. It appears to be at least as effective as oxytocin, the standard treatment, and may have some advantages:

  • Longer-lasting effect, reducing the need for additional medications[2]
  • Potentially less blood loss compared to other treatments[2]
  • May be particularly beneficial in certain high-risk groups, such as women with twin pregnancies or obesity[6][7]

Side Effects

Like all medications, carbetocin can have side effects. Common side effects may include:

  • Low blood pressure (hypotension)[5]
  • Rapid heart rate (tachycardia)[5]
  • Nausea and vomiting[5]
  • Headache[5]
  • Flushing (reddening of the skin)[5]

In rare cases, more serious side effects like abnormal heart rhythms may occur. Researchers are studying the effects of carbetocin on heart function to ensure its safety[8].

Ongoing Research

Carbetocin continues to be the subject of ongoing research. Some areas of current study include:

  • Determining the optimal dose for different patient groups, such as women with obesity or twin pregnancies[6][7]
  • Comparing different routes of administration, such as nasal sprays[3]
  • Investigating its potential use in other conditions, like Prader-Willi Syndrome[3]
  • Studying its long-term safety and effectiveness[3]

As research continues, our understanding of carbetocin and its uses may expand, potentially leading to improved treatments for postpartum hemorrhage and other conditions.

Aspect Details
Main Focus Prevention of postpartum hemorrhage during cesarean deliveries
Dose Range Studied 2 mcg to 140 mcg
Administration Method Intravenous injection over 1 minute following delivery of the fetal head
Primary Outcomes Uterine tone, need for additional uterotonics, estimated blood loss
Secondary Outcomes Side effects (hypotension, tachycardia, nausea, etc.), long-term safety and efficacy
Special Populations Women with BMI ≥ 40 kg/m2, twin pregnancies, laboring women
Other Applications Treatment of hyperphagia in Prader-Willi Syndrome (nasal spray formulation)
Cardiac Effects Studied for potential impact on myocardial repolarization dynamics

FAQ

  • What is carbetocin and how does it work? Carbetocin is a synthetic analogue of oxytocin that causes uterine contraction. It has a longer duration of action (4 to 7 times longer) than oxytocin, which allows for a single dose administration instead of continuous infusion.
  • What is the main purpose of using carbetocin in clinical trials? The main purpose of using carbetocin in clinical trials is to prevent postpartum hemorrhage (PPH), which is a major cause of maternal death worldwide. Researchers are investigating its effectiveness in promoting uterine contraction and reducing blood loss after childbirth, particularly during cesarean deliveries.
  • What doses of carbetocin are being studied in clinical trials? Various doses of carbetocin are being studied, ranging from as low as 2 mcg to as high as 140 mcg. Many trials are focusing on finding the minimum effective dose to achieve adequate uterine tone while minimizing side effects.
  • Are there any potential side effects of carbetocin? Potential side effects of carbetocin include hypotension (low blood pressure), tachycardia (rapid heart rate), nausea, vomiting, chest pain, shortness of breath, headache, and flushing. The severity and frequency of these side effects may be dose-dependent.
  • Are there any other potential uses for carbetocin being explored in clinical trials? Yes, besides its use in obstetrics, carbetocin is also being studied for the treatment of hyperphagia (excessive hunger) in Prader-Willi Syndrome. A long-term, open-label extension study is evaluating the safety and tolerability of carbetocin nasal spray for this condition.

Ongoing Clinical Trials on Carbetocin

  • Study on the Safety of Carbetocin Nasal Spray for Treating Uncontrollable Hunger in Patients with Prader-Willi Syndrome

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Spain

  • Study on Carbetocin Nasal Spray for Reducing Uncontrollable Hunger in Patients with Prader-Willi Syndrome

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy Spain

Glossary

  • Postpartum hemorrhage (PPH): Excessive bleeding after childbirth, which is a major cause of maternal death worldwide.
  • Uterotonic: A drug that stimulates contractions of the uterus, used to prevent or treat postpartum hemorrhage.
  • Elective cesarean delivery: A planned cesarean section that is scheduled in advance, rather than performed as an emergency procedure.
  • Uterine atony: A condition where the uterus fails to contract effectively after childbirth, which can lead to excessive bleeding.
  • ED90: The dose of a drug that is effective in 90% of the population studied.
  • Biased coin up-and-down design: A method used in dose-finding studies where the dose for the next patient is determined based on the response of the previous patient.
  • Hyperphagia: Excessive hunger or increased appetite, often seen in conditions like Prader-Willi Syndrome.
  • Prader-Willi Syndrome: A genetic disorder characterized by weak muscle tone, feeding difficulties, poor growth, and learning disabilities.
  • Open-label extension study: A type of clinical trial where participants know which treatment they are receiving and can continue receiving the treatment for an extended period.
  • Transmural dispersion of repolarization (TDR): A measure of the variability in the electrical recovery of heart muscle cells, which can be affected by certain medications.

References

  1. https://clinicaltrials.gov/study/NCT03556852
  2. https://clinicaltrials.gov/study/NCT01262742
  3. https://clinicaltrials.gov/study/NCT06420297
  4. https://clinicaltrials.gov/study/NCT01630187
  5. https://clinicaltrials.gov/study/NCT01651130
  6. https://clinicaltrials.gov/study/NCT04182360
  7. https://clinicaltrials.gov/study/NCT03672045
  8. https://clinicaltrials.gov/study/NCT03716076