A Phase 4 interventional study of Calcium Carbonate 500 MG and Standard Dose Synthetic Pitocin in Labor Dystocia, Labor Induction and Labor Augmentation, sponsored by Weill Medical College of Cornell University. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-23.
Sponsored by Weill Medical College of Cornell University · Phase 4, Interventional, and Treatment
The investigators think that calcium carbonate can act as an assistive medication to improve contractions during labor.
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.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's planned enrollment of 60 is below the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control group will receive only the standard-dose synthetic oxytocin (Pitocin) alone for labor induction or augmentation.
Drug: Standard Dose Synthetic Pitocin
Participants will start an oral calcium carbonate regimen at the same time as initiating synthetic oxytocin (Pitocin) infusion.
Drug: Calcium Carbonate 500 MG · Drug: Standard Dose Synthetic Pitocin
Calcium Carbonate 500mg, orally, every 4 hours.
The participant will receive thestandard-dose synthetic oxytocin for labor induction or augmentation.
Number of Participants Consented
RedCAP is used to track the consent rates to determine the feasibility of a larger randomized controlled trial.
Time frame: Day 0
Number of Participants Enrolled
RedCAP is used to track the enrollment rates to determine the feasibility of a larger randomized controlled trial.
Time frame: Day 0
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.
Time frame: During hospitalization, approximately 5 days
Duration of Labor (minutes)
Time frame: Approximately 5 days, length of hospitalization
Mode of Delivery
Vaginal Delivery, Operative Delivery, or Cesarean Section
Time frame: Approximately 5 days, length of hospitalization
Number of Postpartum Hemorrhages
Postpartum Hemorrhage as defined as estimated blood loss of over 1000mL.
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)
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
Time frame: Approximately 5 days, length of hospitalization
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.
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
White, Black or African American, Asian, More than One Race/Other, Unknown/Not Reported
Time frame: Day 0
Ethnicity
Hispanic, Non-Hispanic, Unknown/Not Reported
Time frame: Day 0
Plan to share: No
Started Nov 2024 (actual). Primary completion is estimated for Dec 2025, 13 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Calcium Carbonate
Weill Medical College of Cornell University →