Calcium Carbonate to Augment Labor Contractions

NCT06580782 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 24-07027775
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators think that calcium carbonate can act as an assistive medication to improve contractions during labor.

Conditions

Labor Dystocia; Labor Induction; Labor Augmentation

Keywords

Labor; Pregnancy; Labor Augmentation; Calcium Carbonate; labor induction

Outcome Measures

Primary Outcomes (3)

• Number of Participants Consented

  RedCAP is used to track the consent rates to determine the feasibility of a larger randomized controlled trial.

  Day 0

• Number of Participants Enrolled

  RedCAP is used to track the enrollment rates to determine the feasibility of a larger randomized controlled trial.

  Day 0

• Number of Participants that complete the Intervention as prescribed (Adherence)

  RedCAP is used to track the adherence rates to determine the feasibility of a larger randomized controlled trial.

  During hospitalization, approximately 5 days

Secondary Outcomes (10)

• Duration of Labor (minutes)

  Approximately 5 days, length of hospitalization

• Mode of Delivery

  Approximately 5 days, length of hospitalization

• Number of Postpartum Hemorrhages

  Approximately 5 days, length of hospitalization

• Number of Treatment Related Adverse Events

  Approximately 6 weeks after delivery

• Neonatal health (APGAR Score)

  Approximately 5 days, length of hospitalization

Study Arms (2)

Pitocin

ACTIVE COMPARATOR

Control group will receive only the standard-dose synthetic oxytocin (Pitocin) alone for labor induction or augmentation.

Drug: Standard Dose Synthetic Pitocin

Calcium Carbonate with Pitocin

EXPERIMENTAL

Participants will start an oral calcium carbonate regimen at the same time as initiating synthetic oxytocin (Pitocin) infusion.

Drug: Calcium Carbonate 500 MG; Drug: Standard Dose Synthetic Pitocin

Interventions

Calcium Carbonate 500 MG DRUG

Calcium Carbonate 500mg, orally, every 4 hours.

Calcium Carbonate with Pitocin

Standard Dose Synthetic Pitocin DRUG

The participant will receive thestandard-dose synthetic oxytocin for labor induction or augmentation.

Calcium Carbonate with Pitocin; Pitocin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Nulliparas (no prior pregnancy lasting 20 weeks or greater of gestation)
• Gestational age above 36 weeks, at enrollment
• Present for induction or augmentation of labor inclusive of medical indication, elective induction at greater than 39 weeks' gestation, trial of labor after cesarean
• Singleton gestation (a multiple gestation reduced to a singleton, either spontaneously or therapeutically, before 14 0/7 weeks of gestation is acceptable)
• Ability to give informed consent
• Planned to undergo initiation of oxytocin infusion by their maternity care provider

You may not qualify if:

• Unable to understand or read English
• Presence of tachysystole (defined as more than 5 contractions in 10 minutes averaged over 30 minutes), recurrent variable or late fetal decelerations, and bradycardia in the prior 30 minutes before enrollment
• Non-vertex presenting fetus at enrollment
• Planned for cesarean delivery or contraindication to labor by institutional policy (e.g., placenta previa, vasa previa, active genital herpes infection, previous transmural myomectomy)
• Multi-fetal gestation (twins, triplets, and higher order multiples)
• Known contraindication to taking calcium carbonate including renal calculus, high urine calcium levels, elevated serum calcium, low serum phosphate, achlorhydria, or suspected digoxin toxicity.
• Deliveries with fetal chronic and/or pregnancy-related conditions, IUFD (Intra Uterine Fetal Death) or premature \< 36 weeks of gestation.
• Major fetal anomaly suspected prenatally (defined as a fetal anomaly with anticipated neonatal intensive care unit admission)
• Suspected alloimmunization (given the increased likelihood for anticipated neonatal intensive care unit admission)
• Known severe fetal growth restriction (estimated fetal weight \<3rd percentile) or abnormal umbilical artery Doppler studies (given the increased likelihood for anticipated neonatal intensive care unit admission)
• Participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality
• Known allergic reactions to synthetic oxytocin intravenous solution or to Calcium Carbonate
• Significantly impaired consciousness or executive function (e.g., intubated or sedated)
• Patients treated with calcium channel blockers such as nifedipine or magnesium.
• Chronic renal failure and hyperphosphatemia.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Related Links

• Intravenous Calcium to Decrease Blood Loss During Intrapartum Cesarean Delivery: A Randomized Controlled Trial. Obstetrics \& Gynecology, 143(1), 104-112.
• DailyMed-CALCIUM CARBONATE 500MG tablet, chewable. (n.d.)
• Economy, K. E., \& Abuhamad, A. Z. (2001). Calcium channel blockers as tocolytics. Seminars in Perinatology, 25(5), 264-271.
• Association between ionised calcium and severity of postpartum haemorrhage: A retrospective cohort study. British Journal of Anaesthesia
• Fritz, K., Taylor, K., \& Parmar, M. (2024). Calcium Carbonate. In StatPearls. StatPearls Publishing.
• Grier, R. M. (1947). Elective Induction of Labor\*\*Read before the Chicago Gynecological Society, Nov. 15, 1946. American Journal of Obstetrics and Gynecology, 54(3), 511-516.
• Luckas, M. J. M., Taggart, M. J., \& Wray, S. (1999). Intracellular calcium stores and agonist-induced contractions in isolated human myometrium. American Journal of Obstetrics and Gynecology, 181(2), 468-476.
• Monga, M., Campbell, D. F., \& Sanborn, B. M. (1999). Oxytocin-stimulated capacitative calcium entry in human myometrial cells. American Journal of Obstetrics and Gynecology, 181(2), 424-429.
• Papandreou, L., Chasiotis, G., Seferiadis, K., Thanasoulias, N. C., Dousias, V., Tsanadis, G., \& Stefos, T. (2004). Calcium levels during the initiation of labor. European Journal of Obstetrics \& Gynecology and Reproductive Biology, 115(1), 17-22.
• Parratt, J., Taggart, M., \& Wray, S. (1994). Abolition of contractions in the myometrium by acidification in vitro. The Lancet, 344(8924), 717-718.
• Pehlivanoglu, B., Bayrak, S., \& Dogan, M. (2013). A close look at the contraction and relaxation of the myometrium; the role of calcium. Journal of the Turkish German Gynecological Association, 14(4), 230-234.
• Labor Induction Techniques: Which Is the Best? Obstetrics and Gynecology Clinics
• The effects of pH change on Ca++ signaling and force in pregnant human myometrium. American Journal of Obstetrics and Gynecology
• Medical management of canine and feline dystocia. Theriogenology
• Dysfunctional Labor and Myometrial Lactic Acidosis: Obstetrics \& Gynecology
• The effect of experimentally induced hypocalcaemia on uterine activity at parturition in the ewe. Theriogenology
• Whelping and Dystocia: Maximizing Success of Medical Management. Topics in Companion Animal Medicine
• The Myometrium: From Excitation to Contractions and Labour. In H. Hashitani \& R. J. Lang (Eds.), Smooth Muscle Spontaneous Activity

MeSH Terms

Conditions

Dystocia

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Moeun Son, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ester Sanchez, BSN

CONTACT

212-746-2106; ess4006@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data Analyst will be masked to the interventions assigned to participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 30, 2024
• Study Start: November 18, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)