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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitocin | Active Comparator | Control group will receive only the standard-dose synthetic oxytocin (Pitocin) alone for labor induction or augmentation. |
|
| Calcium Carbonate with Pitocin | Experimental | Participants will start an oral calcium carbonate regimen at the same time as initiating synthetic oxytocin (Pitocin) infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Carbonate 500 MG | Drug | Calcium Carbonate 500mg, orally, every 4 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Consented | RedCAP is used to track the consent rates to determine the feasibility of a larger randomized controlled trial. | Day 0 |
| Number of Participants Enrolled | RedCAP is used to track the enrollment rates to determine the feasibility of a larger randomized controlled trial. | 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. | During hospitalization, approximately 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Labor (minutes) | Approximately 5 days, length of hospitalization | |
| Mode of Delivery | Vaginal Delivery, Operative Delivery, or Cesarean Section | Approximately 5 days, length of hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ester Sanchez, BSN | Contact | 212-746-2106 | ess4006@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Moeun Son, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | Recruiting | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Intravenous Calcium to Decrease Blood Loss During Intrapartum Cesarean Delivery: A Randomized Controlled Trial. Obstetrics \& Gynecology, 143(1), 104-112. | View source |
| DailyMed-CALCIUM CARBONATE 500MG tablet, chewable. (n.d.) | View source |
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| ID | Term |
|---|---|
| D004420 | Dystocia |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
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Data Analyst will be masked to the interventions assigned to participants.
| Standard Dose Synthetic Pitocin | Drug | The participant will receive thestandard-dose synthetic oxytocin for labor induction or augmentation. |
|
| Number of Postpartum Hemorrhages | Postpartum Hemorrhage as defined as estimated blood loss of over 1000mL. | Approximately 5 days, length of hospitalization |
| Number of Treatment Related Adverse Events | 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
Pulse: 0 Points: Absent
Grimace (Reflex Irritability): 0 Points: Floppy
Appearance (Skin Color): 0 Points: Blue/Pale
Respiration: 0 Points: Absent
| 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. | Approximately 5 days, length of hospitalization |
| 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 | White, Black or African American, Asian, More than One Race/Other, Unknown/Not Reported | Day 0 |
| Ethnicity | Hispanic, Non-Hispanic, Unknown/Not Reported | Day 0 |
| Economy, K. E., \& Abuhamad, A. Z. (2001). Calcium channel blockers as tocolytics. Seminars in Perinatology, 25(5), 264-271. | View source |
| Association between ionised calcium and severity of postpartum haemorrhage: A retrospective cohort study. British Journal of Anaesthesia | View source |
| Fritz, K., Taylor, K., \& Parmar, M. (2024). Calcium Carbonate. In StatPearls. StatPearls Publishing. | View source |
| Grier, R. M. (1947). Elective Induction of Labor\*\*Read before the Chicago Gynecological Society, Nov. 15, 1946. American Journal of Obstetrics and Gynecology, 54(3), 511-516. | View source |
| Luckas, M. J. M., Taggart, M. J., \& Wray, S. (1999). Intracellular calcium stores and agonist-induced contractions in isolated human myometrium. American Journal of Obstetrics and Gynecology, 181(2), 468-476. | View source |
| Monga, M., Campbell, D. F., \& Sanborn, B. M. (1999). Oxytocin-stimulated capacitative calcium entry in human myometrial cells. American Journal of Obstetrics and Gynecology, 181(2), 424-429. | View source |
| Papandreou, L., Chasiotis, G., Seferiadis, K., Thanasoulias, N. C., Dousias, V., Tsanadis, G., \& Stefos, T. (2004). Calcium levels during the initiation of labor. European Journal of Obstetrics \& Gynecology and Reproductive Biology, 115(1), 17-22. | View source |
| Parratt, J., Taggart, M., \& Wray, S. (1994). Abolition of contractions in the myometrium by acidification in vitro. The Lancet, 344(8924), 717-718. | View source |
| Pehlivanoglu, B., Bayrak, S., \& Dogan, M. (2013). A close look at the contraction and relaxation of the myometrium; the role of calcium. Journal of the Turkish German Gynecological Association, 14(4), 230-234. | View source |
| Labor Induction Techniques: Which Is the Best? Obstetrics and Gynecology Clinics | View source |
| The effects of pH change on Ca++ signaling and force in pregnant human myometrium. American Journal of Obstetrics and Gynecology | View source |
| Medical management of canine and feline dystocia. Theriogenology | View source |
| Dysfunctional Labor and Myometrial Lactic Acidosis: Obstetrics \& Gynecology | View source |
| The effect of experimentally induced hypocalcaemia on uterine activity at parturition in the ewe. Theriogenology | View source |
| Whelping and Dystocia: Maximizing Success of Medical Management. Topics in Companion Animal Medicine | View source |
| The Myometrium: From Excitation to Contractions and Labour. In H. Hashitani \& R. J. Lang (Eds.), Smooth Muscle Spontaneous Activity | View source |
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |