An interventional study of Calcium Carbonate in Pregnancy and Uterine Contraction, sponsored by Wake Forest University Health Sciences. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
The investigators plan to assess (1) duration of induction with oxytocin administration, (2) rate of labor dystocia/failed induction, (3) rate of cesarean section, and (4) maternal/neonatal safety. Currently, calcium carbonate is used by clinicians in patients with varying characteristics, at varying doses, and at various times in their labor process based on their professional preference and experience. The investigators will implement a standardized treatment protocol for calcium carbonate use within a defined patient population who voluntarily agree to prospectively receive the intervention and then analyze predetermined safety and efficacy outcomes in comparison to a historical cohort of patients meeting the criteria for the defined patient population who did not have any documented calcium carbonate use during labor.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's enrollment of 250 is above the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
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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.
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.
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.
Patients receive calcium carbonate (500mg every 4 hours, per standardized treatment protocol) plus standard-dose oxytocin for labor induction
Dietary Supplement: Calcium Carbonate
Patients who presented for induction at the same institution within the previous three years and received standard-dose oxytocin alone for labor induction and were not treated with calcium carbonate
We will be using it in routes and doses consistent with its approved uses. Per the drug label information for Calcium Carbonate USP 500 mg found in the US National Library of Medicine, adults may take 2-4 tablets as symptoms occur and if pregnant to not exceed 10 tablets in 24 hours. Therefore, using a dosing of 500mg every 4 hours will be well below that guidance. When both cervical ripening has been completed and the oxytocin administration begins, the calcium carbonate treatment group will be given calcium carbonate 500mg every 4 hours (not to exceed 10 tablets in 24 hours) until they deliver.
Duration of induction time
Participants in the treatment group will have a shorter duration of induction with oxytocin than those in the retrospective historical control group.
Time frame: During the intervention (time from duration of induction with oxytocin start to delivery)
Rate of labor dystocia
Participants in the treatment group will have a lower rate of labor dystocia than those in the retrospective historical control group.
Time frame: During the intervention (measured from time of induction to delivery)
Rate of cesarean deliveries
Participants in the treatment group will have a lower rate of cesarean deliveries than those in the retrospective historical control group.
Time frame: During the intervention (measured from time of induction to delivery)
Total amount of oxytocin after cervical ripening
Participants in the treatment group will receive a lower amount of oxytocin than those in the retrospective historical control group.
Time frame: During the intervention (time on oxytocin after cervical ripening completed to delivery)
Gastrointestinal side effects
Participants in the treatment group will describe gastrointestinal side effects.
Time frame: During the intervention (time on calcium carbonate to delivery)
Blood loss
Participants in the treatment group will experience less blood loss than those in the retrospective historical control group.
Time frame: Time from delivery to 24 hours of birth
Rate of postpartum hemorrhage (>/= 500mL)
Participants in the treatment group will experience less postpartum hemorrhage than those in the retrospective historical control group.
Time frame: Time from delivery to 24 hours of birth
Neonatal composite adverse outcomes
Neonates of participants in the treatment group will have comparable composite adverse outcomes to those born to participants in the retrospective historical control group.
Time frame: Immediately after the birth until the time of discharge, an average of 3 days
Plan to share: No — Study data will only be shared with those listed on the study team as approved by the internal IRB.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Calcium Carbonate
Wake Forest University Health Sciences →