Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

> 4 Prior deliveries

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Saline

    Other intervention

    slow push intravenous administration of 75 mL of IV

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quantitative Blood Loss (QBL) (continuous variable) administered at Delivery

Standardized volumetric assessment of blood loss during cesarean section

Time frame
Immediately following surgery

Secondary outcomes

1

Quantitative Blood Loss (QBL) (continuous variable) Total

Standardized volumetric/gravimetric assessment of blood loss during cesarean section

Time frame
4 hours following surgery
2

Postpartum hemorrhage

Quantitative blood loss ≥1000mL

Time frame
4 hours following surgery
3

Number of patients with a transfusion requirement

Any transfusion prior to discharge

Time frame
Calculated at 48 hours from delivery
4

Change in Hematocrit (HCT)

Preoperative HCT and Post operative HCT measured though blood sample

Time frame
Preoperative day one, Postoperative day one

Other outcomes

Sponsors and contacts

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