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Calcium Chloride for Prevention of Blood Loss During Intrapartum Cesarean Delivery

NCT05027048 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-06-11

Study results available
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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.

Conditions

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

Interventions

DRUG

Calcium chloride

See arm description above

DRUG

Saline placebo

see arm description above

Sponsors & Collaborators

  • Foundation for Anesthesia Education and Research

    collaborator OTHER

  • Society for Obstetric Anesthesia and Perinatology

    collaborator OTHER

  • Stanford University

    lead OTHER

Principal Investigators

  • Jessica Ansari, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-04
Primary Completion
2023-03-29
Completion
2023-04-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05027048 on ClinicalTrials.gov