Calcium Carbonate to Augment Labor Contractions
NCT Number: NCT06580782
Acronym: CALC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Labor Dystocia|Labor Induction|Labor Augmentation
Sponsor: Weill Medical College of Cornell University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-09

Summary:
This randomized, controlled, open-label pilot study aims to evaluate the feasibility, acceptability, safety, and potential efficacy of using calcium carbonate as an adjunctive uterotonic agent for labor induction. The study hypothesizes that calcium carbonate administration will lead to more effective labor contractions and increase the likelihood of vaginal delivery and improve delivery outcomes.

Primary Outcome Measures: Enrollment, Consent, and Randomization Rate, RedCAP is used to track the enrollment, consent, and randomization rates, Baseline, day 1|Study Adherence, The medical record (Medication Administration Record-MAR) is used to track the administration of the assigned intervention group. The dosages administered to the subject, the time that the subject received the medication, and the continued administration of calcium carbonate every four hours until delivery for those in the intervention arms will be tracked using the Medical Administration Record., Post Intervention, approximately 2 days
Secondary Outcome Measures: Safety, as measured by number of subjects who experience at least one AE, Adverse events will only include those that are determined to be related to the study drug., End of Study, approximately 5 days (length of hospitalization)|Labor Progression, Measure the time from admission to delivery and the duration of the phases of labor in minutes., During hospitalization, approximately 5 days|Labor Outcomes, Track the delivery method of each participant; if the participant delivered via Spontaneous Vaginal Delivery (NSVD), Cesarean Section (CS), or Operative Vaginal Delivery (OVD)., During hospitalization, approximately 5 days|Postpartum Outcomes, Track the instances of PostPartum hemorrhage, diagnosis of chorioamnionitis, diagnosis of endometritis, postpartum fever, the administration of utero-tonics, and maternal ICU admissions., During hospitalization, approximately 5 days|Neonatal Outcomes, Track the instances of Neonatal Intensive Care Unit admissions and Transitional Nursery Admissions., During hospitalization, approximately 5 days|Neonatal APGARs, Track the Appearance, Pulse, Grimace, Activity, and Respirations (APGAR) scores of each neonate. Minimum score of 0 and maximum score of 10, the score of 10 is equivalent to the best outcome., During hospitalization, approximately 5 days|Neonatal Blood Gases, Track the results of neonatal blood gases if they are collected at the time of delivery. Collect results for Cord Arterial Blood ph, results \&lt;7.0 are considered abnormal. Collect results for Cord Arterial Blood Base Excess (mmol/liter), results \&gt;12.0 are considered abnormal., During hospitalization, approximately 5 days