On October 20, 2025, a new clinical trial sponsored by the University of Michigan was announced to investigate the use of prophylactic intravenous calcium gluconate as a method to decrease blood loss during cesarean delivery in pregnant patients facing high risk for uterine atony. The study is not yet recruiting, but it is expected to provide critical insights for healthcare providers and regulatory teams.
In this article:
- Why This Study Matters
- What We Know About Uterine Atony
- Study Design and Interventions
- Frequently Asked Questions
- Conclusion
- Disclaimer
- Full Study Announcement
Why This Study Matters
Uterine atony is one of the leading causes of postpartum hemorrhage, contributing to significant maternal morbidity and mortality worldwide. Despite advances in surgical techniques and medications, cesarean deliveries in high-risk patients still pose challenges in managing blood loss. This study aims to address these gaps by assessing whether intravenous calcium gluconate, administered prophylactically, can improve outcomes for such patients.
What We Know About Uterine Atony
Uterine atony occurs when the uterus fails to contract effectively, leading to excessive bleeding after childbirth. Risk factors include prolonged labor, use of uterine relaxants, maternal obesity, and multiple gestations. Current treatment typically involves uterotonic agents and surgical interventions. However, as surgical options cannot always prevent heavy blood loss, new approaches like calcium supplementation are being explored.
Study Design and Interventions
The trial’s design includes two intervention arms: patients receiving intravenous calcium gluconate and those receiving a saline placebo. Calcium gluconate enters the protocol as a potential agent to strengthen uterine contractions by improving calcium signaling pathways. According to the clinical trial record, these interventions will help assess efficacy and safety in reducing intraoperative and postoperative blood loss.
The study intends to comply with international standards for ethical research practices. Currently marked as “not yet recruiting,” interested parties, such as hospitals or medical institutions, can monitor its updates via ClinicalTrials.gov.
Frequently Asked Questions
- Who is sponsoring the study?
The University of Michigan is the sponsor of this clinical trial. - What are the main interventions?
Participants will receive either intravenous calcium gluconate or saline. - Is the study recruiting participants?
As of October 20, 2025, the study is not yet recruiting. - How will results affect clinical practice?
The trial may introduce a novel approach to managing blood loss and uterine atony during cesarean deliveries, pending its results.
Conclusion
If successful, the outcomes of this trial could have significant implications for clinical care worldwide. Healthcare providers, surgical teams, and regulatory professionals should stay updated on the progression of this study as it evolves.
Disclaimer
This content is for informational purposes only and does not constitute medical or legal advice. Always consult regulatory guidelines and health professionals.
Full Study Announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07217899?term=medical+device