Blood Loss, Surgical, Blood Loss, Postoperative, Uterine Atony
Conditions
Keywords
Cesarean delivery
Brief summary
This research study is being done to learn what effect a single dose of calcium gluconate will have on blood loss at the time of cesarean delivery in pregnancy patients at high risk for uterine atony.
Detailed description
This study is FDA IND exempt
Interventions
slow push intravenous administration of 2g calcium gluconate- 20 mL of 10% Calcium Gluconate in 55mL of IV fluid diluent, Normal Saline CaGluc concentration 26.7 mg/mL
OTHERSaline
slow push intravenous administration of 75 mL of IV
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
This trial will include blinding of the subjects, investigators, and all direct care providers. There will be an anesthesiologist who is not involved in the clinical care of the patient who will be notified of the participant's randomization.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English speaking * Viable Intrauterine Pregnancy, Gestational Age ≥24 weeks * Labor Converted to Cesarean Delivery at High Risk for Atonic Bleeding Defined as: Any exposure to oxytocin infusion for labor augmentation or induction prior to cesarean delivery * Or Scheduled Cesarean Delivery at High Risk for Atonic Bleeding Defined as scheduled Cesarean-Section (CS) plus any one of: 1. \> 4 Prior deliveries 2. General anesthesia 3. Multifetal gestation 4. Polyhydramnios diagnosed by ultrasound within 2 weeks 5. Macrosomia ≥ 4000gms; estimated fetal weight by palpation or by ultrasound 6. Fibroid uterus, defined as: Multiple ≥ 2cm intramural 7. Any history of prior Primary postpartum hemorrhage (PPH) 8. Platelets \< 100,000 (but \>50,000 9. Placenta Previa 10. Body Mass Index (BMI) ≥ 40
Exclusion criteria
* Non-English speaking * Antenatal suspicion for placenta accreta spectrum * History of allergic reaction to Calcium Gluconate * Patients with hypertensive disorder of pregnancy receiving Magnesium Sulfate for seizure prophylaxis * Underlying Renal Disease defined as Cr\>1.0 * Known underlying cardiac condition * Cardiac glycosides (Digoxin) within two weeks for maternal or fetal indication * Treatment with a calcium channel blocker medication within 24 hours of screening * Hypertensive disorder necessitating intravenous antihypertensive medication within 24 hours of screening * Emergent case where study participation could impede care (judgement of obstetrician or anesthesiologist) * Known hypercalcemia * Concurrent use of any drugs that may cause hypercalcemia including 1. Vitamin D 2. Vitamin A 3. Thiazide Diuretics 4. Calcipotriene 5. Teriparatide * Ceftriaxone within 48 hours of screening * Total Parenteral Nutrition (TPN) within 48 hours of screening * Known Coagulopathy International Normalized Ratio (INR) ≥ 1.5 * Vaginal delivery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Blood Loss (QBL) (continuous variable) administered at Delivery | Immediately following surgery | Standardized volumetric assessment of blood loss during cesarean section |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum hemorrhage | 4 hours following surgery | Quantitative blood loss ≥1000mL |
| Number of patients with a transfusion requirement | Calculated at 48 hours from delivery | Any transfusion prior to discharge |
| Change in Hematocrit (HCT) | Preoperative day one, Postoperative day one | Preoperative HCT and Post operative HCT measured though blood sample |
| Quantitative Blood Loss (QBL) (continuous variable) Total | 4 hours following surgery | Standardized volumetric/gravimetric assessment of blood loss during cesarean section |
| Number of participants with second line uterotonic requirements | Calculated at four hours from surgical end | specific items of interest: Methylergonovine, Carboprost, or Misoprostol |
| Intensive Care Unit Admission | Within 48 hours of cesarean section | Assessed using medical records |
| Additional hemostasis procedures | Within 48 hours of cesarean section | Defined as requiring: Balloon Tamponade, Other atony device, B-Lynch, Uterine artery Ligation (Suture), Uterine Artery Embolization, Hysterectomy |
| Change in Hemoglobin (HGB) | Preoperative day one, Postoperative day one | Preoperative HGB - Post operative HGB measured though blood sample |
Countries
United States
Contacts
Primary ContactAnneMarie Opipari, MD
Backup ContactHero Eisley
Outcome results
None listed