Calcium Carbonate to Augment Labor Contractions
- Conditions
- Labor DystociaLabor InductionLabor Augmentation
- Interventions
- Drug: Standard Dose Synthetic Pitocin
- Registration Number
- NCT06580782
- Lead Sponsor
- Weill Medical College of Cornell University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 50
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pitocin Standard Dose Synthetic Pitocin Control group will receive only the standard-dose synthetic oxytocin (Pitocin) alone for labor induction or augmentation. Calcium Carbonate with Pitocin Calcium Carbonate 500 MG Participants will start an oral calcium carbonate regimen at the same time as initiating synthetic oxytocin (Pitocin) infusion. Calcium Carbonate with Pitocin Standard Dose Synthetic Pitocin Participants will start an oral calcium carbonate regimen at the same time as initiating synthetic oxytocin (Pitocin) infusion.
- Primary Outcome Measures
Name Time Method Number of Participants Consented Day 0 RedCAP is used to track the consent rates to determine the feasibility of a larger randomized controlled trial.
Number of Participants Enrolled 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) During hospitalization, approximately 5 days RedCAP is used to track the adherence rates to determine the feasibility of a larger randomized controlled trial.
- Secondary Outcome Measures
Name Time Method Duration of Labor (minutes) Approximately 5 days, length of hospitalization Mode of Delivery Approximately 5 days, length of hospitalization Vaginal Delivery, Operative Delivery, or Cesarean Section
Number of Postpartum Hemorrhages Approximately 5 days, length of hospitalization Postpartum Hemorrhage as defined as estimated blood loss of over 1000mL.
Number of Treatment Related Adverse Events Approximately 6 weeks after delivery Neonatal health (APGAR Score) 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
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 CryNeonatal health (Cord Blood Gases) 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.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 White, Black or African American, Asian, More than One Race/Other, Unknown/Not Reported
Ethnicity Day 0 Hispanic, Non-Hispanic, Unknown/Not Reported
Trial Locations
- Locations (1)
Weill Cornell Medicine
🇺🇸New York, New York, United States