NCT06580782 Calcium Carbonate to Augment Labor Contractions
| NCT ID | NCT06580782 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Labor Dystocia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-11-18 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2024-11-18 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators think that calcium carbonate can act as an assistive medication to improve contractions during labor.
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)
Contact & Investigator
Moeun Son, MD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT06580782 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Labor Dystocia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06580782 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06580782 currently recruiting?
Yes, NCT06580782 is actively recruiting participants. Contact the research team at ess4006@med.cornell.edu for enrollment information.
Where is the NCT06580782 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06580782 clinical trial?
NCT06580782 is sponsored by Weill Medical College of Cornell University. The principal investigator is Moeun Son, MD at Weill Medical College of Cornell University. The trial plans to enroll 60 participants.