Actively Recruiting
Calcium Carbonate to Augment Labor Contractions
Led by Weill Medical College of Cornell University · Updated on 2025-10-23
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of calcium carbonate as a medication to help improve contractions during labor. This study focuses on women undergoing labor induction or augmentation, aiming to see if calcium carbonate can lead to stronger contractions, increase vaginal delivery rates, and improve delivery outcomes. The trial is a phase 4 study sponsored by Weill Medical College of Cornell University. Participants will be randomly assigned to one of two groups. The control group will receive standard-dose synthetic oxytocin (Pitocin) alone for labor induction or augmentation. The experimental group will receive oral calcium carbonate 500 mg every 4 hours alongside the standard-dose synthetic oxytocin infusion. Treatment will continue during hospitalization, which typically lasts about 5 days. During the study, participants will be monitored for adherence to the intervention, labor duration, mode of delivery, postpartum bleeding, treatment-related side effects, and maternal and neonatal health measures such as APGAR scores and cord blood gases. Data on race and ethnicity will also be collected. Safety assessments will continue for up to six weeks after delivery. The total participation duration includes hospitalization of approximately 5 days and follow-up monitoring.
CONDITIONS
Brief Title
Calcium Carbonate to Augment Labor Contractions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Nulliparas (no prior pregnancy lasting 20 weeks or greater of gestation)
- Gestational age above 36 weeks at enrollment
- Present for induction or augmentation of labor including medical indication, elective induction after 39 weeks, or trial of labor after cesarean
- Singleton pregnancy (a multiple gestation reduced to singleton before 14 weeks is allowed)
- Ability to give informed consent
- Planned initiation of oxytocin infusion by maternity care provider
You will not qualify if you...
- Unable to understand or read English
- Presence of excessive contractions or abnormal fetal heart patterns within 30 minutes before enrollment
- Non-head-first (non-vertex) fetal presentation at enrollment
- Planned cesarean delivery or contraindication to labor (e.g., placenta previa, active genital herpes, prior myomectomy)
- Multiple pregnancies (twins, triplets, or more)
- Known contraindications to calcium carbonate (including kidney stones, high urine or serum calcium, low serum phosphate, achlorhydria, or suspected digoxin toxicity)
- Fetal or pregnancy complications like fetal death or premature delivery before 36 weeks
- Major fetal anomalies expected to require intensive care
- Suspected alloimmunization
- Severe fetal growth restriction or abnormal blood flow in the umbilical artery
- Participation in another labor or delivery interventional study
- Known allergies to synthetic oxytocin or calcium carbonate
- Significantly impaired consciousness or sedation
- Use of calcium channel blockers such as nifedipine or magnesium
- Chronic kidney failure or high phosphate levels
- Inability to tolerate oral intake due to nausea or vomiting
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 days, length of hospitalization
Participants receive either standard-dose synthetic oxytocin (Pitocin) alone or in combination with oral calcium carbonate to help induce or augment labor.
Daily visits during hospitalization
Duration - Approximately 6 weeks after delivery
Participants are monitored for treatment-related adverse events and postpartum outcomes following delivery.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
Research Team
E
Ester Sanchez, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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