Carbetocin + Calcium Chloride for Postpartum Hemorrhage

Overseen By Kristi Downey, MSc

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Must not be taking: Digoxin, Ceftriaxone, Tetracycline, others

Disqualifiers: Obesity, Kidney disease, Cardiac disease, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: 1

Duration: Immediate (during cesarean delivery)

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining carbetocin, a long-acting medication, with calcium chloride can better prevent heavy bleeding after childbirth, specifically during scheduled cesarean deliveries. Postpartum hemorrhage, often caused by poor uterine contraction, poses a serious risk for new mothers. The trial compares calcium chloride to a placebo (a harmless, inactive substance) to determine its effectiveness in reducing bleeding. Women scheduled for a cesarean delivery after 37 weeks of pregnancy, without risk factors such as a history of heavy bleeding or certain medical conditions, may be eligible to participate. As an unphased trial, this study offers participants the opportunity to contribute to important research that could enhance postpartum care for many women.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are taking digoxin, calcium channel blockers, or need certain antibiotics like ceftriaxone or tetracycline. If you are on these medications, you may need to stop them before joining the trial.

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

Research has shown that intravenous calcium chloride is generally safe and well-tolerated. In several studies, patients who received calcium chloride did not experience any serious side effects. For instance, one study found it was well-tolerated in 20 patients and might help prevent uterine atony, a condition where the uterus doesn't contract properly after childbirth. Another study observed that blood loss in patients receiving calcium chloride was similar to those given a placebo, yet it remained safe to use.

Carbetocin, a long-acting medication similar to oxytocin, is already approved in many countries to prevent heavy bleeding after childbirth. Its safety is well-documented in these settings. While specific data from this trial isn't available, previous approvals suggest that carbetocin is generally safe when used as directed.

Overall, both calcium chloride and carbetocin have been well-tolerated in past studies, indicating a promising safety profile for preventing postpartum bleeding. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for postpartum hemorrhage, which often involve medications like oxytocin or misoprostol, carbetocin offers a unique approach by mimicking the body's natural oxytocin but with a longer-lasting effect. This could result in more stable and sustained uterine contractions, potentially reducing the need for additional interventions. Researchers are particularly excited because carbetocin's enhanced duration of action might lead to more effective management of bleeding, improving outcomes for new mothers.

What evidence suggests that carbetocin and calcium chloride could be effective for postpartum hemorrhage?

Research has shown that carbetocin, a long-lasting medicine that helps the uterus contract, can effectively manage heavy bleeding after childbirth (postpartum hemorrhage or PPH) by reducing the need for repeated doses compared to oxytocin. In this trial, participants will receive either carbetocin or calcium chloride. Studies have found that calcium chloride, when used with similar medicines, may help reduce bleeding, especially when the uterus doesn't contract properly. In some trials, calcium chloride significantly reduced blood loss by about 350 mL, benefiting women at risk of heavy bleeding after childbirth. Both treatments are generally well-tolerated, with no major side effects reported. This trial will evaluate the effectiveness of using carbetocin and calcium chloride separately to prevent excessive bleeding after childbirth. ^{1 2 3 6 7}

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 patients undergoing elective cesarean delivery to see if a combination of drugs can prevent heavy bleeding after birth. Participants should be those at risk of postpartum hemorrhage due to uterine atony, but specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

I am scheduled for a cesarean delivery at 37 weeks or more without high risk for weak uterine muscles.

I will receive spinal anesthesia as my main anesthetic.

Exclusion Criteria

Risk factors for uterine atony including overdistended uterus due to fetal macrosomia reported on prenatal ultrasound >90th centile or > 4000 gm, multiple gestation, grand multiparity (≥5 births at ≥ 20 weeks gestation), polyhydramnios; history of uterine atony/PPH (documented with blood loss > 2000 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; placenta previa and/or placenta accreta

Emergency cesarean deliveries or women in labor

I haven't taken digoxin in the last 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either intravenous calcium chloride or placebo during scheduled cesarean deliveries to assess uterine tone and manage postpartum hemorrhage

Immediate (during cesarean delivery)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including uterine tone assessments and additional uterotonic requirements

24 hours

In-hospital monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Calcium Chloride
• Carbetocin

Trial Overview The study tests whether giving calcium chloride alongside carbetocin improves the contraction of the uterus and reduces bleeding compared to carbetocin alone. Patients will be randomly assigned to receive either both drugs or carbetocin with a placebo.

How Is the Trial Designed?

Group I: Calcium Active Control 2 Interventions

Intravenous calcium chloride 10% (1g) will be administered in 100ml normal saline, over 10 minutes.

Group II: Placebo Placebo Group 2 Interventions

Intravenous administration of 100ml normal saline, over 10 minutes.

Who Is Running the Clinical Trial?

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Lead Sponsor

Trials

132

Recruited

11,400+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35447502/

Calcium chloride for the prevention of uterine atony during ... Intravenous calcium chloride was well-tolerated by the 20 patients assigned to receive the study drug and may be effective in prevention of uterine atony.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05027048

Calcium Chloride for Prevention of Blood Loss During ... In a randomized, placebo-controlled, double-blind trial, investigators will establish the effect of 1 gram of intravenous calcium chloride upon quantitative ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818022001532

Calcium chloride for the prevention of uterine atony during ... Intravenous calcium chloride was well-tolerated by the 20 patients assigned to receive the study drug and may be effective in prevention of uterine atony.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37917943/

Intravenous Calcium to Decrease Blood Loss During ... However, in the planned subgroup analysis, calcium infusion significantly reduced blood loss by approximately 350 mL. These data suggest that ...

5. safepartum.com safepartum.com/cacl/

Calcium Chloride: The 5th Uterotonic These findings suggest that 1g IV CaCl could make a significant difference for women at risk for PPH, without any major side effects. However, ...

6. stanfordhealthcare.org stanfordhealthcare.org/publications/893/893506.html

Intravenous Calcium to Decrease Blood Loss During ... Median blood loss was 840 mL in patients allocated to calcium chloride (n=60) and 1,051 mL in patients allocated to placebo (n=60), which was not statistically ...

7. med.stanford.edu med.stanford.edu/content/dam/sm/dbds/documents/data-studio/abstract.20191023.pdf

Data Studio This pilot study is aimed to elucidate the potential role of calcium chloride plus standard of care for prevention of uterine atony in women at ...