Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This study is FDA IND exempt
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Randomized to receive intervention |
|
| Arm 2 | Placebo Comparator | Randomized to receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Gluconate | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Blood Loss (QBL) (continuous variable) administered at Delivery | Standardized volumetric assessment of blood loss during cesarean section | Immediately following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Blood Loss (QBL) (continuous variable) Total | Standardized volumetric/gravimetric assessment of blood loss during cesarean section | 4 hours following surgery |
| Postpartum hemorrhage |
Not provided
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:
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AnneMarie Opipari, MD | Contact | 734-763-8048 | opipari@med.umich.edu | |
| Hero Eisley | Contact | 734-763-8048 | parkerdh@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| AnneMarie Opipari, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| Saline | Other | slow push intravenous administration of 75 mL of IV |
|
Quantitative blood loss ≥1000mL
| 4 hours following surgery |
| Number of patients with a transfusion requirement | Any transfusion prior to discharge | Calculated at 48 hours from delivery |
| Change in Hematocrit (HCT) | Preoperative HCT and Post operative HCT measured though blood sample | Preoperative day one, Postoperative day one |
| Change in Hemoglobin (HGB) | Preoperative HGB - Post operative HGB measured though blood sample | Preoperative day one, Postoperative day one |
| Number of participants with second line uterotonic requirements | specific items of interest: Methylergonovine, Carboprost, or Misoprostol | Calculated at four hours from surgical end |
| Intensive Care Unit Admission | Assessed using medical records | Within 48 hours of cesarean section |
| Additional hemostasis procedures | Defined as requiring: Balloon Tamponade, Other atony device, B-Lynch, Uterine artery Ligation (Suture), Uterine Artery Embolization, Hysterectomy | Within 48 hours of cesarean section |
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| D019106 | Postoperative Hemorrhage |
| D014593 | Uterine Inertia |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
| D011183 | Postoperative Complications |
| D004420 | Dystocia |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002125 | Calcium Gluconate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D005942 | Gluconates |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided