Calcium Carbonate to Augment Labor Contractions

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Aug 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether calcium carbonate can help improve labor contractions for women who are experiencing challenges during labor, a condition known as labor dystocia. The researchers believe that this medication might assist in making contractions stronger and more effective. Women who are eligible to participate in this study must be at least 18 years old, have never been pregnant for 20 weeks or more, and be at least 36 weeks along in their current pregnancy. They should also be planning to start labor induction or augmentation, which means helping to start or strengthen their labor.

If you join the trial, you can expect to take calcium carbonate along with oxytocin, a medication commonly used to help with contractions during labor. The trial is currently recruiting participants, but there are some important things to consider. For instance, women with certain medical conditions or complications, such as multiple pregnancies or previous surgeries that affect labor, may not be eligible. It’s also important that participants can understand and give their consent to take part in the study. Overall, this trial hopes to provide insights that could improve labor experiences for many women.

Gender

FEMALE

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)