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New treatment option for Blood Loss, Surgical
Official title Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
ClinicalTrials.gov ID: NCT07217899
What this study is testing
What is Calcium Gluconate?
Calcium Gluconate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for blood loss, surgical.
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
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Or Scheduled Cesarean Delivery at High Risk for Atonic Bleeding Defined as scheduled Cesarean-Section (CS) plus any one of:
- \> 4 Prior deliveries
You likely can't join if
- 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
See the full eligibility 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 \ 50,000
- Placenta Previa
- Body Mass Index (BMI) ≥ 40
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. 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.