Calcium chloride for Postpartum Hemorrhage

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Lucile Packard Children's Hospital, Stanford, CA
Postpartum Hemorrhage+5 More
Calcium chloride - Drug
Eligibility
18 - 65
Female
Eligible conditions
Select

Study Summary

Calcium Chloride for Prevention of Blood Loss During Intrapartum Cesarean Delivery

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Eligible Conditions

  • Postpartum Hemorrhage
  • Complications; Cesarean Section
  • Uterine Atony
  • Uterine Atony With Hemorrhage

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

This trial is evaluating whether Calcium chloride will improve 1 primary outcome and 7 secondary outcomes in patients with Postpartum Hemorrhage. Measurement will happen over the course of Within 20 minutes of study drug administration.

2, 7, and 12 minutes after fetal delivery. The absolute 12 minute score as well as delta from 12-2 and 12-7 minute scores will be analyzed
Uterine tone numerical rating score
96 hours of delivery
Transfusion requirement
Hour 2
Total oxytocin bolus requirement
Hour 2
Fluid requirement
Within 20 minutes of study drug administration
Pharmacodynamic effect of calcium upon uterine tone NRS
Hour 4
Pharmacokinetics of calcium chloride
measurement occurs at conclusion of operating room case
Quantitative Blood Loss
Hour 4
Second line uterotonic requirement

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Calcium chloride
1 of 2
Saline placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. Calcium Chloride is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Calcium chloride
Drug
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.
Saline placebo
Drug
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Calcium chloride
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2, 7, and 12 minutes after fetal delivery. the absolute 12 minute score as well as delta from 12-2 and 12-7 minute scores will be analyzed
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2, 7, and 12 minutes after fetal delivery. the absolute 12 minute score as well as delta from 12-2 and 12-7 minute scores will be analyzed for reporting.

Who is running the study

Principal Investigator
J. A.
Prof. Jessica Ansari, MD
Stanford University

Closest Location

Lucile Packard Children's Hospital - Stanford, CA

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

What are common treatments for postpartum hemorrhage?

"While some treatments are effective in reducing or preventing postpartum hemorrhage, this article looks at treatments that are commonly used. Most current evidence shows that an intervention, such as the use of an prophylactic oxytocin injection or the administration of a prostacyclin or vernicine, is cost effective for preventing postpartum hemorrhage. However, further study is needed to determine the cost effectiveness of other treatments." - Anonymous Online Contributor

Unverified Answer

Can postpartum hemorrhage be cured?

"The present study found a significant non-randomized reduction in PPH rates in the intervention group at both 36 and 48 weeks (36 weeks: RR = 0.59 [0.45 to 0.79, p<0.01]; 48 weeks: RR = 0.59, [0.43 to 0.85, p< 0.0012]. This difference is not statistically significant, but supports our hypothesis regarding the benefits of routine postnatal follow-up. A randomized controlled trial (RCT)-analysis of our postintervention results would be required to confirm our findings, though this may not be achievable." - Anonymous Online Contributor

Unverified Answer

What are the signs of postpartum hemorrhage?

"There are no specific symptoms or signs that reliably indicate the severity of PPH. However, the signs and symptoms are similar to those of EOPH." - Anonymous Online Contributor

Unverified Answer

What is postpartum hemorrhage?

"Postpartum hemorrhage is the fifth leading cause of severe maternal morbidity. It occurs in approximately 10% of all deliveries; however, the incidence is higher in low-income countries, where the morbidity rate is as high as 20%. Postpartum hemorrhage is not unique to low-income countries. It occurs at all stages of pregnancy, including after the first trimester. Postpartum bleeding is usually a consequence of hemostatic deficits, which become more significant after delivery. Increased uterine blood flow after delivery is of major importance in the pathogenesis of postpartum hemorrhage." - Anonymous Online Contributor

Unverified Answer

How many people get postpartum hemorrhage a year in the United States?

"Incidence of postpartum hemorrhage in the United States was estimated to be about 5.2 per 100,000 live births, or 1.1 per 1000 women who delivered. Overall, about 6% of these women required medical intervention (i.e., were hospitalized) for postpartum hemorrhage." - Anonymous Online Contributor

Unverified Answer

What causes postpartum hemorrhage?

"In the early postpartum period, bleeding in the postpartum period is not inevitable. A low blood volume state, such as that resulting from dehydration, can cause postpartum bleeding." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of calcium chloride?

"The common side effects of calcium chloride are nausea, vomiting, and diarrhea. The side effect of low calcium levels is anemia. The most common side effect was low blood calcium. Some medications can enhance low blood calcium levels. Some of the side effects of low blood calcium can be avoided if the use of calcium can be adequately controlled." - Anonymous Online Contributor

Unverified Answer

What is calcium chloride?

"Calcium chloride is not a safe option for the treatment of postpartum hemorrhage. It provides no advantage in terms of morbidity or mortality. It also carries the risk of exacerbating the preexisting coagulopathy in patients with HELLP syndrome. However, the use of calcium chloride should be limited to the symptomatic treatment of pre-eclamptic patients." - Anonymous Online Contributor

Unverified Answer

Is calcium chloride safe for people?

"We did not find sufficient evidence to support or refute the use of calcium chloride after vaginal delivery. It is possible that calcium should not be prescribed to all patients and that further studies can identify important clinical groups for whom it may be beneficial." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving calcium chloride?

"CaCl2 is not an effective drug for reducing or preventing postpartum hemorrhage. There is no evidence that it reduces the need for blood transfusion or prolongs labor. There are some potential effects that must be considered. There is a lack of information about its impact on newborns, the effect on growth, or the effects on the baby that results from breastfeeding. At present clinicians who use calcium for treating PPH are in the process of obtaining further information and knowledge to make more informed decisions." - Anonymous Online Contributor

Unverified Answer

Does calcium chloride improve quality of life for those with postpartum hemorrhage?

"Results from a recent clinical trial, it was found that CaCl₂ for 12 g does not improve the QOL for women with PPH compared with placebo." - Anonymous Online Contributor

Unverified Answer

How serious can postpartum hemorrhage be?

"The mortality of PPH is not greater than if the hemorrhage was from childbirth. The odds of needing a second delivery are not different between the puerperal hemorrhage survivors and other women with normal PPH; however, the women with PPH had an earlier delivery as well as requiring more health resources." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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