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Trial · Interventional

RecruitingPhase 4Registry data

Calcium Carbonate to Augment Labor Contractions

Short name CALC

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
60 participants (estimated)
Sponsor
Weill Medical College of Cornell University · Other
Design
Randomized · Single masking
Countries
1 country

United States

Start
18 Nov 2024
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
First posted
30 Aug 2024
Last update posted
23 Oct 2025
Conditions
Labor Dystocia · Labor Induction · Labor Augmentation

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph 4

    CALC

    NCT06580782

    18 Nov 2024 to est. Dec 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Calcium Carbonate 500 MGDrug
  • Standard Dose Synthetic PitocinDrug

Arms2

  • Active comparator

    Pitocin

    Control group will receive only the standard-dose synthetic oxytocin (Pitocin) alone for labor induction or augmentation.

  • Experimental

    Calcium Carbonate with Pitocin

    Participants will start an oral calcium carbonate regimen at the same time as initiating synthetic oxytocin (Pitocin) infusion.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Number of Participants Consented

    Time frame · Day 0

    Registry description

    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

    Registry description

    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

    Registry description

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

Secondary outcomes(10)
  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

    Registry description

    Vaginal Delivery, Operative Delivery, or Cesarean Section

  3. Number of Postpartum Hemorrhages

    Time frame · Approximately 5 days, length of hospitalization

    Registry description

    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

    Registry description

    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 1. Point: Flexed Limbs 2. Points: Active Pulse: 0 Points: Absent 1. Point: \<100 beats per minute 2. Points: \>100 beats per minute Grimace (Reflex Irritability): 0 Points: Floppy 1. Point: Minimal response to stimulation 2. Points: Prompt response to stumulation Appearance (Skin Color): 0 Points: Blue/Pale 1. Point: Pink Body, Blue Extremitites 2. Points: Pink Respiration: 0 Points: Absent 1. Point: Slow and Irregular 2. Points: Vigorous Cry

  6. Neonatal health (Cord Blood Gases)

    Time frame · Approximately 5 days, length of hospitalization

    Registry description

    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

    Registry description

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

  10. Ethnicity

    Time frame · Day 0

    Registry description

    Hispanic, Non-Hispanic, Unknown/Not Reported

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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 \&lt; 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 \&lt;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)

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