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New treatment option for Postpartum Hemorrhage (Primary)
Official title Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
ClinicalTrials.gov ID: NCT07187544
What this study is testing
What is Calcium Chloride?
Calcium Chloride is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for postpartum hemorrhage (primary).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Postpartum hemorrhage (PPH) is a leading cause of maternal mortality, and its severity has been increasing globally, including in high-income countries. The most common cause of PPH is uterine atony occurring in about 70% of cases.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- Scheduled CD for patients ≥ 37 weeks excluding high risk factors for uterine atony
- Neuraxial anesthesia as the primary anesthetic where intrathecal medications are the primary anesthetic
You likely can't join if
- 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...
- History of uterine atony/PPH (documented with blood loss \> 2000 ml, blood transfusion, use of surgical methods such as Bakri balloon, B-Lynch...
- Obesity with body mass index (BMI) \> 40 kg/m2
- Placenta previa and/or placenta accreta
- Digoxin therapy within 14 days (hypercalcemia can exacerbate digoxin toxicity)
See the full eligibility criteria
- Scheduled CD for patients ≥ 37 weeks excluding high risk factors for uterine atony
- Neuraxial anesthesia as the primary anesthetic where intrathecal medications are the primary anesthetic
- 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
- Digoxin therapy within 14 days (hypercalcemia can exacerbate digoxin toxicity)
- Patients needing intraoperative IV ceftriaxone or tetracycline.
- 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 channel blockade within 24 hours (opposing effect)
- Known history of cardiac disease including arrhythmias, ischemia, and congenital heart disease (to avoid attributing cardiac symptoms to study drugs)
- Preexisting hypertension, preeclampsia or persistent elevated blood pressure above 160/100 mmHg requiring treatment
- Emergency cesarean deliveries or women in labor
- Planned general anesthetic for patients where neuraxial is contraindicated.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.