Calcium Carbonate to Augment Labor Contractions
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWeill Medical College of Cornell University
About this trial
The investigators think that calcium carbonate can act as an assistive medication to improve contractions during labor.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Calcium Carbonate 500 MG
DrugCalcium Carbonate 500mg, orally, every 4 hours.
Standard Dose Synthetic Pitocin
DrugThe participant will receive thestandard-dose synthetic oxytocin for labor induction or augmentation.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: PitocinActive comparator 1 intervention
Group B: Calcium Carbonate with PitocinExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants Consented
RedCAP is used to track the consent rates to determine the feasibility of a larger randomized controlled trial.
Time frame
Day 02
Number of Participants Enrolled
RedCAP is used to track the enrollment rates to determine the feasibility of a larger randomized controlled trial.
Time frame
Day 03
Number of Participants that complete the Intervention as prescribed (Adherence)
RedCAP is used to track the adherence rates to determine the feasibility of a larger randomized controlled trial.
Time frame
During hospitalization, approximately 5 daysSecondary outcomes
1
Duration of Labor (minutes)
Time frame
Approximately 5 days, length of hospitalization2
Mode of Delivery
Vaginal Delivery, Operative Delivery, or Cesarean Section
Time frame
Approximately 5 days, length of hospitalization3
Number of Postpartum Hemorrhages
Postpartum Hemorrhage as defined as estimated blood loss of over 1000mL.
Time frame
Approximately 5 days, length of hospitalization4
Number of Treatment Related Adverse Events
Time frame
Approximately 6 weeks after deliverySponsors and contacts
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Source ClinicalTrials.gov