Trials / Completed

CompletedNCT07056062

Oral Calcium Supplementation in Labor

Effect of Oral Calcium Carbonate on Uterine Contractility and Labor Outcomes: A Randomized Controlled Trial

Status: Completed
Phase: Phase 2 / Phase 3
Study type: Interventional
Enrollment: 89 (actual)

Sponsor: Arrowhead Regional Medical Center · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if oral calcium carbonate can improve uterine contractions and labor outcomes in term pregnancies. It will also evaluate the safety of calcium carbonate when used during labor. The main questions it aims to answer are: Does oral calcium carbonate increase uterine contraction strength? Does it lead to shorter labor duration or higher vaginal delivery rates? What side effects or complications, if any, occur with calcium carbonate use during labor? Researchers will compare oral calcium carbonate to no treatment to see if it helps improve labor efficiency and reduce cesarean delivery rates. Participants will: Be randomly assigned to receive either 2,000 mg of oral calcium carbonate or no intervention Undergo monitoring with an intrauterine pressure catheter to measure contraction strength Be observed for two hours without oxytocin to assess calcium's direct effect on contractions Have data collected on labor progression, delivery outcomes, and neonatal health

Detailed description

In the United States, nearly one-third of deliveries are performed via cesarean section, with labor dystocia remaining a leading indication. Labor dystocia may result from a variety of maternal and fetal factors, including malposition, cephalopelvic disproportion, or ineffective uterine contractions. When contractions are inadequate, the standard intervention is intravenous oxytocin. However, prolonged or high-dose oxytocin administration can lead to receptor desensitization, reducing its effectiveness and increasing the risk of postpartum hemorrhage. Calcium plays a key role in myometrial contractility by facilitating calcium influx through L-type channels in myometrial cells, which triggers intracellular calcium release and action potentials. During labor, upregulation of calcium channels enhances the uterus's responsiveness to contractile stimuli. Elevated serum calcium levels have been associated with stronger and more effective contractions. Adjunctive intravenous calcium administration with oxytocin has been shown to improve labor outcomes, including higher rates of vaginal delivery within 24 hours of induction and reduce blood loss in cesarean deliveries. However, the potential role of oral calcium supplementation in enhancing labor progression has not been evaluated in clinical trials. Given its physiological relevance, accessibility, and low-risk profile, oral calcium may represent a simple adjunct to improve labor efficiency and reduce cesarean rates. This study aims to evaluate the impact of oral calcium carbonate supplementation during labor on uterine contractility and clinical outcomes. The investigators hypothesize that calcium carbonate administered intrapartum will enhance uterine contractions, resulting in higher vaginal delivery rates, shorter time to delivery, and reduced blood loss.

Conditions

Interventions

Type	Name	Description
DRUG	Calcium carbonate	2,000 mg PO calcium carbonate as a single dose

Timeline

Start date: 2024-04-30
Primary completion: 2025-05-30
Completion: 2025-05-30
First posted: 2025-07-09
Last updated: 2025-07-09

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT07056062. Inclusion in this directory is not an endorsement.