Using Calcium Carbonate to Improve Labor Contractions
Calcium Carbonate to Augment Labor Contractions
This study is testing if calcium carbonate can help improve labor contractions for first-time pregnant women who need help with labor.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06580782 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are nulliparous women aged 18 or older, with a singleton pregnancy at or beyond 36 weeks gestation, who are scheduled for labor induction or augmentation.
Not a fit: Patients who are not eligible include those with certain fetal conditions, planned cesarean deliveries, or those who cannot provide informed consent.
Why it matters
Potential benefit: If successful, this approach could lead to improved labor outcomes and higher rates of vaginal deliveries for women undergoing induction.
How similar studies have performed: While the use of calcium carbonate in this context is relatively novel, similar studies exploring adjunctive medications for labor augmentation have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.