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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | No Intervention | Received no medications but monitored for the duration of the study | |
| Calcium carbonate | Experimental | 2,000 mg PO calcium carbonate as a single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium carbonate | Drug | 2,000 mg PO calcium carbonate as a single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Contraction Frequency | Recording the number of contractions in a ten-minute period for 2 hours | Two hours after receiving the study medication or, for control participants, two hours after enrollment. |
| Uterine contraction strength | Recording Montevideo units every 30 minutes for 2 hours | Two hours after receiving the study medication or, for control participants, two hours after enrollment. |
| Peak strength | Recording the max pressure generated during a contraction using an intrauterine pressure catheter during the 2-hour study period | Two hours after receiving the study medication or, for control participants, two hours after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the first stage of labor | Record the length of the first stage of labor from 6 cm to 10 cm dilation | Calculated at the time of delivery |
| Duration of the second stage of labor | Record the time from 10 cm to delivery of the baby |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Valenzuela, MD | Arrowhead Regional Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrowhead Regional Medical Center | Colton | California | 92324 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39307241 | Background | Cai R, Chen L, Xing Y, Deng Y, Li J, Guo F, Liu L, Xie C, Yang J. RETRACTED: Oxytocin with calcium vs oxytocin for induction of labor in women with term premature rupture of membranes: a randomized controlled trial. Am J Obstet Gynecol MFM. 2024 Nov;6(11):101502. doi: 10.1016/j.ajogmf.2024.101502. Epub 2024 Sep 20. | |
| 37917943 | Background |
| Label | URL |
|---|---|
| Related Info | View source |
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Study has already been completed, will analyze data first and then decide
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 26, 2024 | Jun 21, 2025 | Prot_SAP_ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 9, 2025 | Sep 26, 2025 | 1 |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D004420 | Dystocia |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
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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.
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| Calculated at the time of delivery |
| Mode of delivery | Determine whether or not patient had a spontaneous vaginal bleeding, operative vaginal delivery, or cesarean delivery | Calculated at the time of delivery |
| Pitocin dose | Record the maximum dose of Pitocin used during labor | Calculated at the time of delivery |
| Postpartum hemorrhage | Determine which patients had a blood loss of greater than or equal to 1000 mL | at the time of discharge (assessed up to 5 days) |
| Neonatal outcomes | Determine which babies were admitted to neonatal intensive care unit (NICU) and had a low 5- minute APGAR score | at the time of discharge (assessed up to 5 days) |
| Ansari JR, Yarmosh A, Michel G, Lyell D, Hedlin H, Cornfield DN, Carvalho B, Bateman BT. Intravenous Calcium to Decrease Blood Loss During Intrapartum Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2024 Jan 1;143(1):104-112. doi: 10.1097/AOG.0000000000005441. Epub 2023 Nov 3. |
| 15223159 | Background | Papandreou L, Chasiotis G, Seferiadis K, Thanasoulias NC, Dousias V, Tsanadis G, Stefos T. Calcium levels during the initiation of labor. Eur J Obstet Gynecol Reprod Biol. 2004 Jul 15;115(1):17-22. doi: 10.1016/j.ejogrb.2003.11.032. |
| 24592112 | Background | Pehlivanoglu B, Bayrak S, Dogan M. A close look at the contraction and relaxation of the myometrium; the role of calcium. J Turk Ger Gynecol Assoc. 2013 Dec 1;14(4):230-4. doi: 10.5152/jtgga.2013.67763. eCollection 2013. |
| 12853086 | Background | Wray S, Jones K, Kupittayanant S, Li Y, Matthew A, Monir-Bishty E, Noble K, Pierce SJ, Quenby S, Shmygol AV. Calcium signaling and uterine contractility. J Soc Gynecol Investig. 2003 Jul;10(5):252-64. doi: 10.1016/s1071-5576(03)00089-3. |
| 24553167 | Background | Obstetric care consensus no. 1: safe prevention of the primary cesarean delivery. Obstet Gynecol. 2014 Mar;123(3):693-711. doi: 10.1097/01.AOG.0000444441.04111.1d. |
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |