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Recruiting NCT06580782

Calcium Carbonate to Augment Labor Contractions

Phase IV Interventional Labor Dystocia Labor Induction Labor Augmentation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Calcium Carbonate 500 MG, Standard Dose Synthetic Pitocin.
Who it may be relevant to
Registry conditions: Labor Dystocia, Labor Induction, Labor Augmentation. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

This study plans to study the acceptance and safety of using calcium carbonate as an medicine to help the labor induction process. The study aims to find if the use of calcium carbonate will lead to better labor contractions and increase the percentage of vaginal deliveries and improve delivery outcomes.

Interventions

  • Drug Calcium Carbonate 500 MG
    Calcium Carbonate 500mg, orally, every 4 hours.
  • Drug Standard Dose Synthetic Pitocin
    The participant will receive thestandard-dose synthetic oxytocin for labor induction or augmentation.

Primary outcome measures

  • Number of Participants Consented [Time frame: Day 0]
  • Number of Participants Enrolled [Time frame: Day 0]
  • Number of Participants that complete the Intervention as prescribed (Adherence) [Time frame: During hospitalization, approximately 5 days]
Secondary outcome measures (10)
  • Duration of Labor (minutes) [Time frame: Approximately 5 days, length of hospitalization]
  • Mode of Delivery [Time frame: Approximately 5 days, length of hospitalization]
  • Number of Postpartum Hemorrhages [Time frame: Approximately 5 days, length of hospitalization]
  • Number of Treatment Related Adverse Events [Time frame: Approximately 6 weeks after delivery]
  • Neonatal health (APGAR Score) [Time frame: Approximately 5 days, length of hospitalization]
  • Neonatal health (Cord Blood Gases) [Time frame: Approximately 5 days, length of hospitalization]
  • Maternal Health (Number of Subject who experience PostPartum Fever) [Time frame: Approximately 5 days, length of hospitalization]
  • Practicality of Administering Calcium Carbonate, as measured by number of subjects who were administered the total prescribed intervention [Time frame: Approximately 5 days, length of hospitalization]
  • Race [Time frame: Day 0]
  • Ethnicity [Time frame: Day 0]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Weill Cornell Medicine — New York

Identifiers

NCT: NCT06580782 · 24-07027775

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗