Using Calcium Carbonate to Improve Labor Contractions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and acceptance of calcium carbonate as a medication to assist in the labor induction process. The goal is to determine if calcium carbonate can enhance labor contractions, thereby increasing the likelihood of vaginal deliveries and improving overall delivery outcomes. Participants will receive either calcium carbonate or standard synthetic Pitocin during labor. The study focuses on nulliparous women who are at least 36 weeks pregnant and are undergoing labor induction or augmentation.

Why it matters

Who can join: the full rules

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)

Where it's running

• Weill Cornell Medicine
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Moeun Son, MD — Weill Medical College of Cornell University
• Study coordinator: Ester Sanchez, BSN
• Email: ess4006@med.cornell.edu
• Phone: 212-746-2106

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.