The investigators think that calcium carbonate can act as an assistive medication to improve contractions during labor.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Calcium Carbonate 500mg, orally, every 4 hours.
The participant will receive thestandard-dose synthetic oxytocin for labor induction or augmentation.
Weill Cornell Medicine
New York, New York, United States
RECRUITINGNumber of Participants Consented
RedCAP is used to track the consent rates to determine the feasibility of a larger randomized controlled trial.
Time frame: Day 0
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 0
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 days
Duration of Labor (minutes)
Time frame: Approximately 5 days, length of hospitalization
Mode of Delivery
Vaginal Delivery, Operative Delivery, or Cesarean Section
Time frame: Approximately 5 days, length of hospitalization
Number of Postpartum Hemorrhages
Postpartum Hemorrhage as defined as estimated blood loss of over 1000mL.
Time frame: Approximately 5 days, length of hospitalization
Number of Treatment Related Adverse Events
Time frame: Approximately 6 weeks after delivery
Neonatal health (APGAR Score)
APGAR (Activity, Pulse, Grimace, Appearance, Respiration). A normal APGAR score ranges from 8-10. An abnormal score ranges from 0-7. Each scoring indicator can range from 0 to 2 points. Activity (Muscle Tone): 0 Points: Absent 1. Point: Flexed Limbs 2. Points: Active Pulse: 0 Points: Absent 1. Point: \<100 beats per minute 2. Points: \>100 beats per minute Grimace (Reflex Irritability): 0 Points: Floppy 1. Point: Minimal response to stimulation 2. Points: Prompt response to stumulation Appearance (Skin Color): 0 Points: Blue/Pale 1. Point: Pink Body, Blue Extremitites 2. Points: Pink Respiration: 0 Points: Absent 1. Point: Slow and Irregular 2. Points: Vigorous Cry
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Time frame: Approximately 5 days, length of hospitalization
Neonatal health (Cord Blood Gases)
Normal Ranges Arterial pH: 7.20 - 7.30 Venous pH: 7.25 - 7.35 Base Excess: -8 to -2 mmol/L Abnormal Ranges pH \< 7.0 (Arterial and Venous) Base Excess \< -16 mmol/L (Arterial and Venous) Abnormal Ranges indicate potential neonatal hypoxia or acidemia.
Time frame: Approximately 5 days, length of hospitalization
Maternal Health (Number of Subject who experience PostPartum Fever)
Time frame: Approximately 5 days, length of hospitalization
Practicality of Administering Calcium Carbonate, as measured by number of subjects who were administered the total prescribed intervention
Time frame: Approximately 5 days, length of hospitalization
Race
White, Black or African American, Asian, More than One Race/Other, Unknown/Not Reported
Time frame: Day 0
Ethnicity
Hispanic, Non-Hispanic, Unknown/Not Reported
Time frame: Day 0