Trial · Interventional
RecruitingPhase 4Registry dataCalcium 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
- Ph 4
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.
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.
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.
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)
Duration of Labor (minutes)
Time frame · Approximately 5 days, length of hospitalization
Mode of Delivery
Time frame · Approximately 5 days, length of hospitalization
Registry description
Vaginal Delivery, Operative Delivery, or Cesarean Section
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.
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
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
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.
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
Registry description
White, Black or African American, Asian, More than One Race/Other, Unknown/Not Reported
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
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