PregnancyNCT06352775
Calcium Carbonate on Labor Induction
A study testing Calcium Carbonate in people with Pregnancy and Uterine Contraction, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Uterine Contraction
- What is being tested?
- Calcium Carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 30 Dec 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
About this study
Official title: The Effect of Calcium Carbonate on Labor Induction: A Pilot Study
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.
Read the detailed description
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.
- Conditions
- Pregnancy, Uterine Contraction
- Being tested
- Calcium Carbonate
- Keywords
- Pregnancy, Uterine contraction, Calcium carbonate, Labor induction time, Labor dystocia
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium CarbonateDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Treatment Group | Experimental | Patients receive calcium carbonate (500mg every 4 hours, per standardized treatment protocol) plus standard-dose oxytocin for labor induction Receives: Dietary Supplement: Calcium Carbonate |
| Retrospective Historical Control Group | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the intervention (measured from time of induction to delivery)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after the birth until the time of discharge, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Jun 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The quasi-experimental design will include a prospective treatment group and retrospective historical control group. The prospective treatment group will identify 50 patients who will be voluntarily consented and receive calcium carbonate (500mg every 4 hours, per standardized treatment protocol) plus standard-dose oxytocin. This group will be compared against a retrospective historical control group of 200 randomly selected patients (1:4 ratio) who presented for induction at the same institution within the previous three years and received standard-dose oxytocin alone.
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Forgie, DO, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352775
- Sponsor's protocol ID
- IRB00107112
- Status last verified
- Oct 2026
- First submitted
- 7 Mar 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data will only be shared with those listed on the study team as approved by the internal IRB.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Calcium Carbonate on Labor Induction: A Pilot Study
- ClinicalTrials.gov ID
- NCT06352775
- Acronym / sponsor ID
- IRB00107112
- Conditions
- Pregnancy, Uterine Contraction
- Keywords
- Pregnancy, Uterine contraction, Calcium carbonate, Labor induction time, Labor dystocia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The quasi-experimental design will include a prospective treatment group and retrospective historical control group. The prospective treatment group will identify 50 patients who will be voluntarily consented and receive calcium carbonate (500mg every 4 hours, per standardized treatment protocol) plus standard-dose oxytocin. This group will be compared against a retrospective historical control group of 200 randomly selected patients (1:4 ratio) who presented for induction at the same institution within the previous three years and received standard-dose oxytocin alone.
| Arm | Type | Receives |
|---|---|---|
| Prospective Treatment Group | Experimental | Dietary Supplement: Calcium CarbonatePatients receive calcium carbonate (500mg every 4 hours, per standardized treatment protocol) plus standard-dose oxytocin for labor induction |
| Retrospective Historical Control Group | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium CarbonateWe 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. | Dietary supplement | Prospective Treatment Group |
Primary outcome
Duration of induction time
Time frame: During the intervention (time from duration of induction with oxytocin start to delivery)
Participants in the treatment group will have a shorter duration of induction with oxytocin than those in the retrospective historical control group.
Rate of labor dystocia
Time frame: During the intervention (measured from time of induction to delivery)
Participants in the treatment group will have a lower rate of labor dystocia than those in the retrospective historical control group.
6 secondary outcomes
Rate of cesarean deliveries
Time frame: During the intervention (measured from time of induction to delivery)
Total amount of oxytocin after cervical ripening
Time frame: During the intervention (time on oxytocin after cervical ripening completed to delivery)
Gastrointestinal side effects
Time frame: During the intervention (time on calcium carbonate to delivery)
Blood loss
Time frame: Time from delivery to 24 hours of birth
Rate of postpartum hemorrhage (>/= 500mL)
Time frame: Time from delivery to 24 hours of birth
Neonatal composite adverse outcomes
Time frame: Immediately after the birth until the time of discharge, an average of 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. Study data will only be shared with those listed on the study team as approved by the internal IRB.
Related trials for Pregnancy
Active, not recruitingObservational study
A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
Atypical Hemolytic Uremic Syndrome(aHUS)
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Recruiting
Feasibility of the "One-Finger Technique" for Identifying the Upper Left Ureter During Para-Aortic Lymphadenectomy
Ovary Cancer, Cervical Cancer
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Forgie, DO principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Carbonate in people with Pregnancy and Uterine Contraction, run by Wake Forest University Health Sciences 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of induction time (time frame: During the intervention (time from duration of induction with oxytocin start to delivery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.