Calcium Carbonate to Augment Labor Contractions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number of Participants Consented
Study Overview
Brief Summary
The investigators think that calcium carbonate can act as an assistive medication to improve contractions during labor.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Data Analyst will be masked to the interventions assigned to participants.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 inclusive of medical indication, elective induction at greater than 39 weeks' gestation, trial of labor after cesarean
- •Singleton gestation (a multiple gestation reduced to a singleton, either spontaneously or therapeutically, before 14 0/7 weeks of gestation is acceptable)
- •Ability to give informed consent
- •Planned to undergo initiation of oxytocin infusion by their maternity care provider
Exclusion Criteria
- •Unable to understand or read English
- •Presence of tachysystole (defined as more than 5 contractions in 10 minutes averaged over 30 minutes), recurrent variable or late fetal decelerations, and bradycardia in the prior 30 minutes before enrollment
- •Non-vertex presenting fetus at enrollment
- •Planned for cesarean delivery or contraindication to labor by institutional policy (e.g., placenta previa, vasa previa, active genital herpes infection, previous transmural myomectomy)
- •Multi-fetal gestation (twins, triplets, and higher order multiples)
- •Known contraindication to taking calcium carbonate including renal calculus, high urine calcium levels, elevated serum calcium, low serum phosphate, achlorhydria, or suspected digoxin toxicity.
- •Deliveries with fetal chronic and/or pregnancy-related conditions, IUFD (Intra Uterine Fetal Death) or premature < 36 weeks of gestation.
- •Major fetal anomaly suspected prenatally (defined as a fetal anomaly with anticipated neonatal intensive care unit admission)
- •Suspected alloimmunization (given the increased likelihood for anticipated neonatal intensive care unit admission)
- •Known severe fetal growth restriction (estimated fetal weight <3rd percentile) or abnormal umbilical artery Doppler studies (given the increased likelihood for anticipated neonatal intensive care unit admission)
- •Participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality
- •Known allergic reactions to synthetic oxytocin intravenous solution or to Calcium Carbonate
- •Significantly impaired consciousness or executive function (e.g., intubated or sedated)
- •Patients treated with calcium channel blockers such as nifedipine or magnesium.
- •Chronic renal failure and hyperphosphatemia.
- •Inability to tolerate oral intake (i.e., nausea/vomiting)
Arms & Interventions
Pitocin
Control group will receive only the standard-dose synthetic oxytocin (Pitocin) alone for labor induction or augmentation.
Intervention: Standard Dose Synthetic Pitocin (Drug)
Calcium Carbonate with Pitocin
Participants will start an oral calcium carbonate regimen at the same time as initiating synthetic oxytocin (Pitocin) infusion.
Intervention: Calcium Carbonate 500 MG (Drug)
Calcium Carbonate with Pitocin
Participants will start an oral calcium carbonate regimen at the same time as initiating synthetic oxytocin (Pitocin) infusion.
Intervention: Standard Dose Synthetic Pitocin (Drug)
Outcomes
Primary Outcomes
Number of Participants Consented
Time Frame: Day 0
RedCAP is used to track the consent rates to determine the feasibility of a larger randomized controlled trial.
Number of Participants Enrolled
Time Frame: Day 0
RedCAP is used to track the enrollment rates to determine the feasibility of a larger randomized controlled trial.
Number of Participants that complete the Intervention as prescribed (Adherence)
Time Frame: During hospitalization, approximately 5 days
RedCAP is used to track the adherence rates to determine the feasibility of a larger randomized controlled trial.
Secondary Outcomes
- Duration of Labor (minutes)(Approximately 5 days, length of hospitalization)
- Mode of Delivery(Approximately 5 days, length of hospitalization)
- Number of Postpartum Hemorrhages(Approximately 5 days, length of hospitalization)
- Number of Treatment Related Adverse Events(Approximately 6 weeks after delivery)
- Neonatal health (APGAR Score)(Approximately 5 days, length of hospitalization)
- Neonatal health (Cord Blood Gases)(Approximately 5 days, length of hospitalization)
- Maternal Health (Number of Subject who experience PostPartum Fever)(Approximately 5 days, length of hospitalization)
- Practicality of Administering Calcium Carbonate, as measured by number of subjects who were administered the total prescribed intervention(Approximately 5 days, length of hospitalization)
- Race(Day 0)
- Ethnicity(Day 0)