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Labor DystociaPhase 4CALCNCT06580782

Calcium Carbonate to Augment Labor Contractions

A Phase 4 study testing Calcium Carbonate 500 MG and Standard Dose Synthetic Pitocin in people with Labor Dystocia and Labor Induction, run by Weill Medical College of Cornell University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The investigators think that calcium carbonate can act as an assistive medication to improve contractions during labor. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Calcium Carbonate 500 MG and Standard Dose Synthetic Pitocin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
18 Nov 2024to Dec 2025
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 16Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ester Sanchez, BSN contact

212-746-2106

ess4006@med.cornell.edu

United States1 site, 1 recruiting

  • Weill Cornell Medicine

    New York, New York, 10065

    Ester Sanchez, BSN, 212-746-2106, ess4006@med.cornell.edu

    Moeun Son, MD

    Recruiting

Other trials in United States

About this study

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

Read the 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.

Being tested
Calcium Carbonate 500 MG, Standard Dose Synthetic Pitocin
Keywords
Labor, Pregnancy, Labor Augmentation, Calcium Carbonate, labor induction
Medical subject headings
Dystocia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Calcium Carbonate 500 MGDrug

    Calcium Carbonate 500mg, orally, every 4 hours.

  • Standard Dose Synthetic PitocinDrug

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

Study groups in NCT06580782
Study groupRoleWhat they receive
PitocinActive comparatorControl group will receive only the standard-dose synthetic oxytocin (Pitocin) alone for labor induction or augmentation.
Receives: Drug: Standard Dose Synthetic Pitocin
Calcium Carbonate with PitocinExperimentalParticipants will start an oral calcium carbonate regimen at the same time as initiating synthetic oxytocin (Pitocin) infusion.
Receives: Drug: Calcium Carbonate 500 MG; Drug: Standard Dose Synthetic Pitocin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Consented

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

    Measured: Day 0

  2. Number of Participants Enrolled

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

    Measured: Day 0

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

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

    Measured: During hospitalization, approximately 5 days

Secondary outcomes (10)

  1. Duration of Labor (minutes)

    Measured: Approximately 5 days, length of hospitalization

  2. Mode of Delivery

    Vaginal Delivery, Operative Delivery, or Cesarean Section

    Measured: Approximately 5 days, length of hospitalization

  3. Number of Postpartum Hemorrhages

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

    Measured: Approximately 5 days, length of hospitalization

  4. Number of Treatment Related Adverse Events

    Measured: Approximately 6 weeks after delivery

  5. Neonatal health (APGAR Score)

    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

    Measured: Approximately 5 days, length of hospitalization

  6. Neonatal health (Cord Blood Gases)

    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.

    Measured: Approximately 5 days, length of hospitalization

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

    Measured: 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

    Measured: Approximately 5 days, length of hospitalization

  9. Race

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

    Measured: Day 0

  10. Ethnicity

    Hispanic, Non-Hispanic, Unknown/Not Reported

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2024
  2. Study start18 Nov 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06580782
Sponsor's protocol ID
24-07027775
Acronym
CALC
Status last verified
Oct 2025
First submitted
28 Aug 2024
Last updated
23 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Calcium Carbonate 500 MG and Standard Dose Synthetic Pitocin in people with Labor Dystocia and Labor Induction, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ester Sanchez, BSN (212-746-2106, ess4006@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Consented (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06580782.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.

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