RecruitingPhase 4NCT06580782

Calcium Carbonate to Augment Labor Contractions

Sponsor

Weill Medical College of Cornell University

Enrollment

60 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

Labor Dystocia

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

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 Criteria16

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)