NCT07217899招募中2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Quantitative Blood Loss (QBL) (continuous variable) administered at Delivery
研究概览
简要总结
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.
详细描述
This study is FDA IND exempt
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Arm 2
Placebo Comparator
Randomized to receive placebo
干预措施: Saline (Other)
Arm 1
Experimental
Randomized to receive intervention
干预措施: Calcium Gluconate (Drug)
结局指标
主要结局
Quantitative Blood Loss (QBL) (continuous variable) administered at Delivery
时间窗: Immediately following surgery
Standardized volumetric assessment of blood loss during cesarean section
次要结局
- Postpartum hemorrhage(4 hours following surgery)
- Intensive Care Unit Admission(Within 48 hours of cesarean section)
- Quantitative Blood Loss (QBL) (continuous variable) Total(4 hours following surgery)
- Number of patients with a transfusion requirement(Calculated at 48 hours from delivery)
- Change in Hematocrit (HCT)(Preoperative day one, Postoperative day one)
- Change in Hemoglobin (HGB)(Preoperative day one, Postoperative day one)
- Number of participants with second line uterotonic requirements(Calculated at four hours from surgical end)
- Additional hemostasis procedures(Within 48 hours of cesarean section)
研究者
Molly Stout
Professor of Obstetrics and Gynecology Innovation, Associate Professor of Obstetrics and Gynecology and Section Head, Maternal Fetal Medicine
University of Michigan
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Does giving calcium during cesarean section help reduce blood loss? A study on High Risk MothersThird-stage hemorrhage,CTRI/2025/05/087002JIPMER Intramural Research fund180
已完成
不适用
Evaluation of the Efficacy of Calcium a -Ketoglutarate(AKG-Ca) in Improving Human AgingAgingNCT07114536Shenzhen Hygieia Biotech Co., Ltd34
已完成
3 期
Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving DialysisKidney DiseaseChronic Kidney DiseaseNCT00094484Amgen400
已完成
3 期
Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo ParathyroidectomyHyperparathyroidism, PrimaryHypercalcemiaNCT00975221Amgen67
已完成
1 期
A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943ObesityNCT06313528Eli Lilly and Company85