Calcium Chloride for Prevention of Blood Loss During Intrapartum Cesarean Delivery

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-04

Study Completion Date

2023-04-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Uterine Atony Uterine Atony With Hemorrhage Postpartum Hemorrhage Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind, placebo controlled randomized clinical trial with 1:1 allocation

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The patient, obstetrician, anesthesiologist, and clinical research staff will be blinded to the intervention. Drugs will be labeled only as "study drug"

Study Groups

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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.

Group Type EXPERIMENTAL

Calcium chloride

Intervention Type DRUG

See arm description above

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.

Group Type PLACEBO_COMPARATOR

Saline placebo

Intervention Type DRUG

see arm description above

Interventions

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Calcium chloride

See arm description above

Intervention Type DRUG

Saline placebo

see arm description above

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No