Oral Calcium Supplementation in Labor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Calcium Carbonate to Augment Labor Contractions

NCT06580782

Labor Dystocia Labor Induction Labor Augmentation

RECRUITING PHASE4

Calcium Carbonate on Labor Induction

NCT06352775

Pregnancy Uterine Contraction

ACTIVE_NOT_RECRUITING NA

Calcium Chloride for Prevention of Uterine Atony During Cesarean

NCT03867383

Uterine Atony Uterine Atony With Hemorrhage Cesarean Section Complications

COMPLETED PHASE1/PHASE2

Efficacy of Bicarbonate on the Risk of Assisted Delivery in Nulliparous Women With Prolonged Labour

NCT07321379

Prolonged Labor Labor Dystocia

NOT_YET_RECRUITING NA

Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony

NCT07217899

Blood Loss, Surgical Blood Loss, Postoperative Uterine Atony

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Uterine Contraction Labor Complication Labor Active Dilated Cm Labor Dystocia Labor Duration Labor Labor Delivery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants in the intervention group received a single oral dose of 2,000 mg calcium carbonate, consisting of four over-the-counter antacid tablets. This dose is well below the recommended daily maximum of 8,000 mg. The control group received no medication. Common side effects of calcium carbonate include constipation, bloating, and abdominal discomfort, while serious side effects such as hypercalcemia are rare.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard of care

Received no medications but monitored for the duration of the study

Group Type NO_INTERVENTION

No interventions assigned to this group

Calcium carbonate

2,000 mg PO calcium carbonate as a single dose

Group Type EXPERIMENTAL

Calcium carbonate

Intervention Type DRUG

2,000 mg PO calcium carbonate as a single dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Calcium carbonate

2,000 mg PO calcium carbonate as a single dose

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TUMS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Had an intrauterine pressure catheter in place
* Term gestation, greater than or equal to 37 weeks of gestation
* Singleton pregnancy
* Cephalic presentation
* \> 18 years of age

Exclusion Criteria

* incarceration
* multiple gestation
* active illicit drug use
* abnormal clinical pelvimetry
* Suspected fetal macrosomia defined as estimated fetal weight ≥4250 grams
* intrauterine growth restriction
* abnormal placentation
* prior cesarean delivery
* maternal history of arrhythmia
* hyperparathyroidism
* heart failure
* renal or hepatic failure
* nephrolithiasis
* receipt of medications known to affect uterine contractility-such as magnesium sulfate, terbutaline, or recent misoprostol in the last four hours

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No