Weill Cornell Medicine
New York, 10065, United States
Location status: Recruiting
NCT Number: NCT06580782
The investigators think that calcium carbonate can act as an assistive medication to improve contractions during labor.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 4
New York, 10065, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Calcium Carbonate 500mg, orally, every 4 hours.
The participant will receive thestandard-dose synthetic oxytocin for labor induction or augmentation.
Time frame: Day 0
RedCAP is used to track the consent rates to determine the feasibility of a larger randomized controlled trial.
Time frame: Day 0
RedCAP is used to track the enrollment rates to determine the feasibility of a larger randomized controlled trial.
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.
Time frame: Approximately 5 days, length of hospitalization
Time frame: Approximately 5 days, length of hospitalization
Vaginal Delivery, Operative Delivery, or Cesarean Section
Time frame: Approximately 5 days, length of hospitalization
Postpartum Hemorrhage as defined as estimated blood loss of over 1000mL.
Time frame: Approximately 6 weeks after delivery
Time frame: Approximately 5 days, length of hospitalization
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
Pulse:
0 Points: Absent
Grimace (Reflex Irritability):
0 Points: Floppy
Appearance (Skin Color):
0 Points: Blue/Pale
Respiration:
0 Points: Absent
Time frame: Approximately 5 days, length of hospitalization
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
Time frame: Approximately 5 days, length of hospitalization
Time frame: Day 0
White, Black or African American, Asian, More than One Race/Other, Unknown/Not Reported
Time frame: Day 0
Hispanic, Non-Hispanic, Unknown/Not Reported
Contact information is provided by the study sponsor or research team.
Weill Medical College of Cornell University
Other
Acronym: CALC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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