Recruiting

Calcium Carbonate

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06580782

Conditions

Labor Dystocia

Labor Induction

Labor Augmentation

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Calcium Carbonate 500 MG

Standard Dose Synthetic Pitocin

Study Details

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

Study ID

NCT06580782

Start date

Nov 18, 2024

Status verified date

Oct, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pitocin

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

experimental: Calcium Carbonate with Pitocin

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

Interventions

Calcium Carbonate 500 MG

Calcium Carbonate 500mg, orally, every 4 hours.

Standard Dose Synthetic Pitocin

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

Primary outcome measure

  • Number of Participants Consented [ Time Frame: Day 0 ]
  • Number of Participants Enrolled [ Time Frame: Day 0 ]
  • Number of Participants that complete the Intervention as prescribed (Adherence) [ Time Frame: During hospitalization, approximately 5 days ]

Central Contacts and Locations

Central contacts

Ester Sanchez, BSN

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

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Ester Sanchez, BSN

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

Principal Investigator:

Moeun Son, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Oct 23, 2025

Last verified

Oct, 2025

Keywords

  • Labor
  • Pregnancy
  • Labor Augmentation
  • Calcium Carbonate
  • labor induction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2025-10-23.