Calcium Carbonate on Labor Induction (NCT06352775) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Calcium Carbonate on Labor Induction
United States250 participantsStarted 2024-06-01
Plain-language summary
The investigators aim to evaluate the safety and efficacy of administering calcium carbonate to laboring participants undergoing labor inductions. The investigators hypothesize that calcium carbonate is a low-risk preventative measure to decrease oxytocin induction time and dosage, decrease the rate of labor dystocia, decrease the rate of cesarean deliveries, and demonstrate no differences in maternal or neonatal safety outcomes.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult laboring patients ( ≥ 18 years of age)
* Able to speak and read English or Spanish (for historical cohort, preferred language should be English or Spanish)
* Singleton gestation
* Greater ≥ 37 weeks gestation in vertex presentation
* Present for induction of labor inclusive of medical indication, elective indication at greater than 39 weeks gestation, trial of labor after cesarean
* Receive standard-dose oxytocin during induction
Exclusion Criteria:
* Participants will be excluded from the study if they do not meet the above inclusion criteria or they will be further excluded under the following circumstances:
* Known need for cesarean section prior to induction of labor
* Known allergy to calcium carbonate
* Known contraindication to taking calcium carbonate including renal calculus, high urine calcium levels, elevated serum calcium, low serum phosphate, achlorhydria, or suspected digoxin toxicity.
* Inability to tolerate oral intake (i.e., nausea/vomiting)
* Need to be nothing by mouth (NPO)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Duration of induction time
Timeframe: During the intervention (time from duration of induction with oxytocin start to delivery)
2
Rate of labor dystocia
Timeframe: During the intervention (measured from time of induction to delivery)