Carbetocin with calcium chloride to improve uterine contraction after elective cesarean

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a double-blind, randomized trial at a single center, people having an elective cesarean at or beyond 37 weeks under neuraxial anesthesia are randomized to receive carbetocin with either calcium chloride or placebo. The interventions are given around the time of uterotonic administration and clinicians measure uterine tone and blood loss during and after the operation. Patients with known high-risk factors for uterine atony or certain medical contraindications (for example recent digoxin use or significant kidney disease) are excluded. The aim is to determine whether adding calcium to a longer-acting uterotonic (carbetocin) reduces postpartum hemorrhage or the need for additional uterotonic interventions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Scheduled CD for patients ≥ 37 weeks excluding high risk factors for uterine atony
2. Neuraxial anesthesia as the primary anesthetic where intrathecal medications are the primary anesthetic

Exclusion Criteria:

1. Risk factors for uterine atony including:

   1. 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
   2. 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)
   3. Obesity with body mass index (BMI) \> 40 kg/m2
   4. Placenta previa and/or placenta accreta
2. Digoxin therapy within 14 days (hypercalcemia can exacerbate digoxin toxicity)
3. Patients needing intraoperative IV ceftriaxone or tetracycline.
4. Kidney disease including Stage 3 chronic kidney disease, serum creatinine above 120 mmol/L or GFR \<60 ml/min (to prevent hypercalcemia due to reduced creatinine clearance in those with impaired kidney function as calcium is renally excreted)
5. Calcium channel blockade within 24 hours (opposing effect)
6. Known history of cardiac disease including arrhythmias, ischemia, and congenital heart disease (to avoid attributing cardiac symptoms to study drugs)
7. Preexisting hypertension, preeclampsia or persistent elevated blood pressure above 160/100 mmHg requiring treatment
8. Emergency cesarean deliveries or women in labor
9. Planned general anesthetic for patients where neuraxial is contraindicated.

Where it's running

• Mount Sinai Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Mrinalini Balki, MD — Mount Sinai Hospital
• Study coordinator: Mrinalini Balki, MD
• Email: mrinalini.balki@uhn.ca
• Phone: 416-586-4800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Investigating how calcium affects carbetocin's ability to contract the uterus after cesarean delivery

  This study is testing if different levels of calcium can help carbetocin work better to make the uterus contract after a cesarean delivery to prevent heavy bleeding.

  Recruiting Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Toronto, Ontario · NCT06930391

• Using the Alma System to treat severe bleeding after childbirth

  This study is testing whether the Alma System can safely and effectively stop severe bleeding after childbirth in women who have experienced postpartum hemorrhage.

  Recruiting Phase 3 ResQ Medical Ltd · Brooklyn, New York and 1 other locations · NCT06646653

• Long-term outcomes after vacuum-induced tamponade for postpartum hemorrhage

  This study will look at women who had postpartum hemorrhage treated with vacuum-induced tamponade at a Zurich hospital to see how they fared over time, including future pregnancies and fertility.

  Recruiting University of Zurich · Zurich, Canton of Zurich · NCT07885072

• Calcium Gluconate After Birth to Reduce Blood Loss in Vaginal Delivery

  This study tests whether giving calcium gluconate right after the baby is born can help reduce blood loss for people having a vaginal delivery.

  Recruiting Rambam Health Care Campus · Haifa · NCT07714902

• Carbetocin Alone vs Carbetocin Plus Oxytocin After Elective Cesarean Delivery

  This study tests whether giving carbetocin by itself after an elective cesarean is just as good as adding a supplemental oxytocin infusion.

  Recruiting Phase 4 Mansoura University · Buraidah, Al-Qassim Region · NCT07636421

• Simulation-based postpartum hemorrhage training to boost anesthesiology team performance

  Senior anesthesiology residents will try a high-fidelity simulation program for postpartum hemorrhage to see if it improves how their teams perform during obstetric emergencies.

  Recruiting Hacettepe University · Ankara, Ankara · NCT07519252

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.