Labor Augmentation, Labor Dystocia, Labor Induction
Conditions
Keywords
Labor, Pregnancy, Labor Augmentation, Calcium Carbonate, labor induction
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.
Interventions
Calcium Carbonate 500mg, orally, every 4 hours.
DRUGStandard Dose Synthetic Pitocin
The participant will receive thestandard-dose synthetic oxytocin for labor induction or augmentation.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Data Analyst will be masked to the interventions assigned to participants.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 (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. |
| 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 Cry |
| 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 |
| Maternal Health (Number of Subject who experience PostPartum Fever) | Approximately 5 days, length of hospitalization | — |
| 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 |
Countries
United States
Contacts
Primary ContactEster Sanchez, BSN
Outcome results
None listed