Recruiting NCT07217899
Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Calcium Gluconate, Saline.
- Who it may be relevant to
- Registry conditions: Blood Loss, Surgical, Blood Loss, Postoperative, Uterine Atony. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase II, Randomized, Double Blinded, Placebo Controlled Superiority Trial of Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
Overview
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
- Drug Calcium Gluconate
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 - Other Saline
slow push intravenous administration of 75 mL of IV
Primary outcome measures
- Quantitative Blood Loss (QBL) (continuous variable) administered at Delivery [Time frame: Immediately following surgery]
Secondary outcome measures (8)
- Quantitative Blood Loss (QBL) (continuous variable) Total [Time frame: 4 hours following surgery]
- Postpartum hemorrhage [Time frame: 4 hours following surgery]
- Number of patients with a transfusion requirement [Time frame: Calculated at 48 hours from delivery]
- Change in Hematocrit (HCT) [Time frame: Preoperative day one, Postoperative day one]
- Change in Hemoglobin (HGB) [Time frame: Preoperative day one, Postoperative day one]
- Number of participants with second line uterotonic requirements [Time frame: Calculated at four hours from surgical end]
- Intensive Care Unit Admission [Time frame: Within 48 hours of cesarean section]
- Additional hemostasis procedures [Time frame: Within 48 hours of cesarean section]
Eligibility criteria
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:
- > 4 Prior deliveries
- General anesthesia
- Multifetal gestation
- Polyhydramnios diagnosed by ultrasound within 2 weeks
- Macrosomia ≥ 4000gms; estimated fetal weight by palpation or by ultrasound
- Fibroid uterus, defined as: Multiple ≥ 2cm intramural
- Any history of prior Primary postpartum hemorrhage (PPH)
- Platelets < 100,000 (but >50,000
- Placenta Previa
- 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
- Vitamin D
- Vitamin A
- Thiazide Diuretics
- Calcipotriene
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT07217899 · HUM00259931