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Recruiting

NCT Number: NCT06580782

Calcium Carbonate to Augment Labor Contractions

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Weill Cornell Medicine

New York, 10065, United States

Location status: Recruiting

Location contact

Ester Sanchez, BSN

CONTACT

[email protected]

212-746-2106

Moeun Son, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Calcium Carbonate 500 MG

Drug

Calcium Carbonate 500mg, orally, every 4 hours.

Standard Dose Synthetic Pitocin

Drug

The participant will receive thestandard-dose synthetic oxytocin for labor induction or augmentation.

Primary outcomes

  1. Number of Participants Consented

    Time frame: Day 0

    RedCAP is used to track the consent rates to determine the feasibility of a larger randomized controlled trial.

  2. Number of Participants Enrolled

    Time frame: Day 0

    RedCAP is used to track the enrollment rates to determine the feasibility of a larger randomized controlled trial.

  3. Number of Participants that complete the Intervention as prescribed (Adherence)

    Time frame: During hospitalization, approximately 5 days

    RedCAP is used to track the adherence rates to determine the feasibility of a larger randomized controlled trial.

Secondary outcomes

  1. Duration of Labor (minutes)

    Time frame: Approximately 5 days, length of hospitalization

  2. Mode of Delivery

    Time frame: Approximately 5 days, length of hospitalization

    Vaginal Delivery, Operative Delivery, or Cesarean Section

  3. Number of Postpartum Hemorrhages

    Time frame: Approximately 5 days, length of hospitalization

    Postpartum Hemorrhage as defined as estimated blood loss of over 1000mL.

  4. Number of Treatment Related Adverse Events

    Time frame: Approximately 6 weeks after delivery

  5. Neonatal health (APGAR Score)

    Time frame: Approximately 5 days, length of hospitalization

    APGAR (Activity, Pulse, Grimace, Appearance, Respiration). A normal APGAR score ranges from 8-10. An abnormal score ranges from 0-7. Each scoring indicator can range from 0 to 2 points.

    Activity (Muscle Tone):

    0 Points: Absent

    • Point: Flexed Limbs
    • Points: Active

    Pulse:

    0 Points: Absent

    • Point: <100 beats per minute
    • Points: >100 beats per minute

    Grimace (Reflex Irritability):

    0 Points: Floppy

    • Point: Minimal response to stimulation
    • Points: Prompt response to stumulation

    Appearance (Skin Color):

    0 Points: Blue/Pale

    • Point: Pink Body, Blue Extremitites
    • Points: Pink

    Respiration:

    0 Points: Absent

    • Point: Slow and Irregular
    • Points: Vigorous Cry
  6. Neonatal health (Cord Blood Gases)

    Time frame: Approximately 5 days, length of hospitalization

    Normal Ranges Arterial pH: 7.20 - 7.30 Venous pH: 7.25 - 7.35 Base Excess: -8 to -2 mmol/L

    Abnormal Ranges pH < 7.0 (Arterial and Venous) Base Excess < -16 mmol/L (Arterial and Venous)

    Abnormal Ranges indicate potential neonatal hypoxia or acidemia.

  7. Maternal Health (Number of Subject who experience PostPartum Fever)

    Time frame: Approximately 5 days, length of hospitalization

  8. 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

  9. Race

    Time frame: Day 0

    White, Black or African American, Asian, More than One Race/Other, Unknown/Not Reported

  10. Ethnicity

    Time frame: Day 0

    Hispanic, Non-Hispanic, Unknown/Not Reported

Study contacts

Contact information is provided by the study sponsor or research team.

Ester Sanchez, BSN

CONTACT

[email protected]

212-746-2106

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Acronym: CALC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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