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NCT05027048 · ClinicalTrials.gov registry record · Phase 3
Calcium Chloride for Prevention of Blood Loss During Intrapartum Cesarean Delivery
A Phase 3 study of Postpartum Hemorrhage and Cesarean Section Complications, sponsored by Stanford University.
- Completed
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT05027048: Completed Phase 3 study of Postpartum Hemorrhage and Cesarean Section Complications, sponsored by Stanford University.
NCT05027048 is a Phase 3 study of Postpartum Hemorrhage and Cesarean Section Complications that has completed, run by Stanford University. The registered enrollment target is 120 participants, below the 774-participant average among 19 other Postpartum Hemorrhage trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05027048, a Phase 3 study of Postpartum Hemorrhage and Cesarean Section Complications, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Saline placebo
- DRUG Calcium chloride
Study Locations (1)
California
- Jessica Ansari - Pacifica
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-04-04 |
| Est. Completion | 2023-04-03 |
| Phase | Phase 3 |
What the finished NCT05027048 record still lists
NCT05027048 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 774-participant average among 19 other Postpartum Hemorrhage trials with a reported enrollment target (84% lower).
The record links to 4 conditions, with Postpartum Hemorrhage appearing as the primary indexed condition, and to 2 interventions - of which Saline placebo is the first listed.
NCT05027048 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05027048 about?
NCT05027048 is a clinical study titled "Calcium Chloride for Prevention of Blood Loss During Intrapartum Cesarean Delivery". 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 ...
What is the current status of trial NCT05027048?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2022-04-04. Estimated completion is 2023-04-03.
What conditions does trial NCT05027048 study?
This clinical trial studies the following conditions: Postpartum Hemorrhage, Cesarean Section Complications, Uterine Atony, Uterine Atony With Hemorrhage.
What interventions are being tested in trial NCT05027048?
The interventions under investigation include: Saline placebo (DRUG), Calcium chloride (DRUG).
Who is sponsoring clinical trial NCT05027048?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05027048 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05027048's enrollment target sits among peer trials
120 7th of 19 higher than 12 of 19 other Postpartum Hemorrhage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postpartum Hemorrhage trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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