Phase 3
N=120
Calcium Chloride for Prevention of Blood Loss During Intrapartum Cesarean Delivery
Uterine Atony · Uterine Atony With Hemorrhage · Postpartum Hemorrhage · Cesarean Section Complications
Bottom Line
View on ClinicalTrials.gov: NCT05027048 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Quantitative Blood Loss — 840; 1051 milliliters — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Calcium chloride (Drug); Saline placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quantitative Blood Loss |
840; 1051 | <0.05 sig |
| SECONDARY Number of Participants With Postpartum Hemorrhage |
24; 34 | — |
| SECONDARY Number of Participants With Second Line Uterotonic Requirement |
18; 24 | — |
| SECONDARY Number of Patients With a Transfusion Requirement |
5; 9 | — |
| SECONDARY Change in Hematocrit From Baseline |
7.8; 9.6 | — |
| SECONDARY Total Oxytocin Bolus Requirement |
3; 3 | — |
| SECONDARY Uterine Tone Numerical Rating Score, 7 Minutes After Fetal Delivery |
7; 6.5 | 0.415 |
| SECONDARY Uterine Tone Numerical Rating Score, 12 Minutes After Fetal Delivery |
7; 7 | 0.566 |
| SECONDARY Fluid Requirement |
1594; 1502 | — |
| SECONDARY Percent Change in Mean Arterial Pressure |
16; 12 | 0.348 |
| SECONDARY Percent Change in Heart Rate From Baseline |
0; 10 | 0.011 sig |
| SECONDARY Total Phenylephrine Requirement |
1.02; 1.09 | — |
| SECONDARY Pharmacokinetics of Calcium Chloride - Baseline Ionized Calcium |
1.15; 1.16 | 0.25 |
| SECONDARY Pharmacokinetics of Calcium Chloride - Peak Change in Ionized Calcium From 1 Gram of Calcium Chloride |
0.39 | — |
| SECONDARY Pharmacodynamic Effect of Calcium Upon Uterine Tone NRS |
— | — |
Summary
Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality worldwide. Up to 80% of PPH is caused by uterine atony, the failure of the uterine smooth muscle to contract and compress the uterine vasculature after delivery. Laboratory and epidemiological studies show that low extracellular and serum calcium levels, respectively, decrease uterine contractility. A pilot study performed by the investigators supports the hypothesis that intravenous calcium chloride is well tolerated and may have utility in preventing uterine atony. The proposed research will establish the relationship between uterine tone and calcium through a clinical trial with an incorporated pharmacokinetic and pharmacodynamic (PK/PD) study. In a randomized, placebo-controlled, double-blind trial, investigators will establish the effect of 1 gram of intravenous calcium chloride upon quantitative blood loss and uterine tone during cesarean delivery in parturients with high risk of uterine atony. Investigators will concurrently collect serial venous blood samples to measure calcium for PK/PD modeling in this pregnant study cohort. High-quality clinical research and development of novel therapeutics to manage uterine atony are critical to reduce the high maternal morbidity and mortality from PPH.
Eligibility Criteria
Inclusion Criteria
- Patient had a trial of labor for vaginal delivery prior to cesarean
- Patient received an oxytocin infusion for labor augmentation or induction prior to cesarean
Exclusion Criteria
- renal dysfunction with serum Cr >1.0 mg/dL
- known underlying cardiac condition
- treatment with digoxin within the last 2 weeks for a maternal or fetal indication
- treatment with a calcium channel blocker medication within 24 hours
- hypertension necessitating intravenous antihypertensive medication within 24 hours
- emergent case in which study participation could in any way impede patient care by the judgement of the obstetrician, anesthesiologist, or bedside nurse
Data sourced from ClinicalTrials.gov (NCT05027048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.