Primary outcomeMedian· measurement occurs at conclusion of operating room case
Quantitative Blood Loss
| Group | Value (milliliters) |
|---|---|
| Calcium Chloride | 840 |
| Saline Placebo | 1051 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataCalcium Chloride for Prevention of Blood Loss During Intrapartum Cesarean Delivery
Short name CALBLOC
NCTNCT05027048 (opens ClinicalTrials.gov in a new tab)Other id62206Other idMRTG-02-15-2022-AnsariOther idYIG-2020
This trial does not test a peptide that PepBank tracks.
- Measures Oxytocin, does not give it. It appears in an outcome measure.
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 120 participants (actual)
- Sponsor
- Stanford University · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 4 Apr 2022
- Primary completion
- 29 Mar 2023
- Completion
- 3 Apr 2023
- First posted
- 30 Aug 2021
- Last update posted
- 11 Jun 2024
- Conditions
- Uterine Atony · Uterine Atony With Hemorrhage · Postpartum Hemorrhage · Cesarean Section Complications
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
202220232024
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Calcium chlorideDrug
- Saline placeboDrug
Arms2
Experimental
Calcium chloride
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp. This intervention occurs IN ADDITION TO standard care with oxytocin 2 unit bolus and infusion at 7.5 units per hour which begins immediately after fetal delivery.
Placebo comparator
Saline placebo
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp. This intervention occurs IN ADDITION TO standard care with oxytocin 2 unit bolus and infusion at 7.5 units per hour which begins immediately after fetal delivery.
Primary outcomes1
Outcomes the sponsor listed as primary.
Quantitative Blood Loss
Time frame · measurement occurs at conclusion of operating room case
Registry description
Standardized volumetric and gravimetric assessment of blood loss during cesarean. Note: will analyze all participants, but planned subgroup analysis will also occur excluding patients with non-atonic reasons for blood loss including hysterotomy extension, placental abruption, cervical or vaginal laceration, etc
Secondary outcomes(14)
Number of Participants With Postpartum Hemorrhage
Time frame · operative course (within 4-6 hours of fetal delivery)
Registry description
Postpartum hemorrhage was defined as quantitative blood loss \> 1000 milliliters during operative course
Number of Participants With Second Line Uterotonic Requirement
Time frame · within 4 hours of delivery
Registry description
Yes/no: did the patient require treatment with methylergonovine, carboprost, and/or misoprostol for uterine atony
Number of Patients With a Transfusion Requirement
Time frame · 96 hours of delivery
Registry description
Yes/no, if patient required transfusion of packed red blood cells prior to hospital discharge
Change in Hematocrit From Baseline
Time frame · 1 day
Registry description
Measured pre-delivery hematocrit minus measured post-operative day 1 hematocrit. Correction factor of 3 hematocrit points per unit packed red blood cells transfused
Total Oxytocin Bolus Requirement
Time frame · Cesarean duration, within 4-6 hours of fetal delivery
Registry description
Total dose oxytocin bolus during cesarean
Uterine Tone Numerical Rating Score, 7 Minutes After Fetal Delivery
Time frame · 7 minutes after fetal delivery, 5 minutes after initiating study drug infusion
Registry description
Uterine tone assessment: Obstetricians at the study institution use the following validated scale to grade uterine tone for all cesarean deliveries. The obstetrician places their hand directly on the uterine fundus and scores the adequacy of contraction. The interrater characteristics of this scale have been published (Cole et al, 2021). The scale ranges from 0-10. A score of 0 is the worst possible score and represents a flaccid, atonic uterus. A score of 10 is the best possible score and represents a firmly-contracted uterus.
Uterine Tone Numerical Rating Score, 12 Minutes After Fetal Delivery
Time frame · 12 minutes after fetal delivery, 10 minutes after initiating study drug infusion
Registry description
Uterine tone assessment: Obstetricians at the study institution use the following validated scale to grade uterine tone for all cesarean deliveries. The obstetrician places their hand directly on the uterine fundus and scores the adequacy of contraction. The interrater characteristics of this scale have been published (Cole et al, PMID 33652161). The scale ranges from 0-10. A score of 0 is the worst possible score and represents a flaccid, atonic uterus. A score of 10 is the best possible score and represents a firmly-contracted uterus.
Fluid Requirement
Time frame · Operating room duration, usually 2 hours
Registry description
Total crystalloid required during cesarean delivery in mL
Percent Change in Mean Arterial Pressure
Time frame · every 5 minutes for 30 minutes after study drug infusion initiation, compared to baseline
Registry description
Baseline mean arterial blood pressure recorded as average of first 6 mean arterial blood pressures recorded in operating room. Percent change calculated as measured mean arterial blood pressure minus baseline, divided by baseline. Reported here as the maximal decrease in mean arterial pressure. Repeated measures ANOVA reported in Statistical Analysis.
Percent Change in Heart Rate From Baseline
Time frame · every 5 minutes for 30 minutes after study drug infusion initiation, compared to baseline
Registry description
Baseline heart rate recorded as average of first 6 heart rates recorded in operating room. Percent change calculated as measured heart rate minus baseline, divided by baseline. Maximal % increase in heart rate reported here. Repeated measures ANOVA used to analyze overall trend in Statistical Analysis below.
Total Phenylephrine Requirement
Time frame · Duration of operating room time, up to 240 minutes
Registry description
Total phenylephrine in milligrams administered while in the operating room
Pharmacokinetics of Calcium Chloride - Baseline Ionized Calcium
Time frame · In the operating room prior to study drug administration (generally <30 minutes prior to fetal delivery and study drug administration)
Registry description
Measured using an Abbott istat machine and CG8+ cartridge to determine venous blood gas ionized calcium levels
Pharmacokinetics of Calcium Chloride - Peak Change in Ionized Calcium From 1 Gram of Calcium Chloride
Time frame · At Tmax (conclusion of the 10-minute intravenous calcium chloride infusion
Registry description
Generated from a 2-compartment population pharmacokinetic model in NONMEM using serial venous blood gas ionized calcium concentrations.
Pharmacodynamic Effect of Calcium Upon Uterine Tone NRS
Time frame · Within 20 minutes of study drug administration
Registry description
Data were not collected. This measure required blood specimens to be obtained at the time of tone scores and this was not done.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeCount of participants· operative course (within 4-6 hours of fetal delivery)
Number of Participants With Postpartum Hemorrhage
| Group | Value (Participants) |
|---|---|
| Calcium Chloride | 24 |
| Saline Placebo | 34 |
Secondary outcomeCount of participants· within 4 hours of delivery
Number of Participants With Second Line Uterotonic Requirement
| Group | Value (Participants) |
|---|---|
| Calcium Chloride | 18 |
| Saline Placebo | 24 |
Secondary outcomeCount of participants· 96 hours of delivery
Number of Patients With a Transfusion Requirement
| Group | Value (Participants) |
|---|---|
| Calcium Chloride | 5 |
| Saline Placebo | 9 |
Secondary outcomeMedian· 1 day
Change in Hematocrit From Baseline
| Group | Value (Percentage of hematocrit) |
|---|---|
| Calcium Chloride | 7.8 |
| Saline Placebo | 9.6 |
Secondary outcomeMedian· Cesarean duration, within 4-6 hours of fetal delivery
Total Oxytocin Bolus Requirement
| Group | Value (units) |
|---|---|
| Calcium Chloride | 3 |
| Saline Placebo | 3 |
Secondary outcomeMedian· 7 minutes after fetal delivery, 5 minutes after initiating study drug infusion
Uterine Tone Numerical Rating Score, 7 Minutes After Fetal Delivery
| Group | Value (units on a scale) |
|---|---|
| Calcium Chloride | 7 |
| Saline Placebo | 6.5 |
Secondary outcomeMedian· 12 minutes after fetal delivery, 10 minutes after initiating study drug infusion
Uterine Tone Numerical Rating Score, 12 Minutes After Fetal Delivery
| Group | Value (units on a scale) |
|---|---|
| Calcium Chloride | 7 |
| Saline Placebo | 7 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Calcium Chloride1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp. | 0 / 60 | 0 / 60 | 23 / 60 |
| Saline Placebo60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp. | 0 / 60 | 0 / 60 | 25 / 60 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
More studies
1 study on this page
Indexing hint: Randomized controlled trial · 2024
Intravenous Calcium to Decrease Blood Loss During Intrapartum Cesarean Delivery: A Randomized Controlled Trial.
Ansari et al. 2024Obstetrics and gynecologycited by 17
PMID 37917943DOI 10.1097/aog.0000000000005441PUB-37917943
Full text at the publisher
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 55 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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