Calcium Carbonate to Augment Labor Contractions

NCT ID: NCT06580782

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-18
• Study Completion Date: 2025-12-31

Brief Summary

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

Detailed Description

This study plans to study the acceptance and safety of using calcium carbonate as an medicine to help the labor induction process. The study aims to find if the use of calcium carbonate will lead to better labor contractions and increase the percentage of vaginal deliveries and improve delivery outcomes.

Conditions

Labor Dystocia; Labor Induction; Labor Augmentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pitocin

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

Group Type: ACTIVE_COMPARATOR

Standard Dose Synthetic Pitocin

Intervention Type: DRUG

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

Calcium Carbonate with Pitocin

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

Group Type: EXPERIMENTAL

Calcium Carbonate 500 MG

Intervention Type: DRUG

Calcium Carbonate 500mg, orally, every 4 hours.

Standard Dose Synthetic Pitocin

Intervention Type: DRUG

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

Interventions

Calcium Carbonate 500 MG

Calcium Carbonate 500mg, orally, every 4 hours.

Intervention Type: DRUG

Standard Dose Synthetic Pitocin

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 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

Exclusion Criteria

• 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.
• Inability to tolerate oral intake (i.e., nausea/vomiting)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moeun Son, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ester Sanchez, BSN

Role: CONTACT

ess4006@med.cornell.edu

212-746-2106

Facility Contacts

Ester Sanchez, BSN

Role: primary

ess4006@med.cornell.edu

212-746-2106

Related Links

https://doi.org/10.1097/AOG.0000000000005441

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DailyMed-CALCIUM CARBONATE 500MG tablet, chewable. (n.d.)

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Economy, K. E., \& Abuhamad, A. Z. (2001). Calcium channel blockers as tocolytics. Seminars in Perinatology, 25(5), 264-271.

https://doi.org/10.1016/j.bja.2020.11.020

Association between ionised calcium and severity of postpartum haemorrhage: A retrospective cohort study. British Journal of Anaesthesia

http://www.ncbi.nlm.nih.gov/books/NBK562303/

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https://doi.org/10.1016/S0002-9378(16)39418-2

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https://doi.org/10.1016/S0002-9378(99)70573-9

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.

https://doi.org/10.1016/j.ejogrb.2003.11.032

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.

https://doi.org/10.1016/S0140-6736(94)92209-8

Parratt, J., Taggart, M., \& Wray, S. (1994). Abolition of contractions in the myometrium by acidification in vitro. The Lancet, 344(8924), 717-718.

https://doi.org/10.5152/jtgga.2013.67763

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https://doi.org/10.1016/j.ogc.2017.08.011

Labor Induction Techniques: Which Is the Best? Obstetrics and Gynecology Clinics

https://doi.org/10.1067/mob.2003.229

The effects of pH change on Ca++ signaling and force in pregnant human myometrium. American Journal of Obstetrics and Gynecology

https://doi.org/10.1016/j.theriogenology.2008.04.031

Medical management of canine and feline dystocia. Theriogenology

https://doi.org/10.1097/01.AOG.0000118306.82556.43

Dysfunctional Labor and Myometrial Lactic Acidosis: Obstetrics \& Gynecology

https://doi.org/10.1016/0093-691X(84)90446-1

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Other Identifiers

24-07027775

Identifier Type: -

Identifier Source: org_study_id