RECRUITING

Calcium Carbonate to Augment Labor Contractions

Conditions

Labor Dystocia Labor Induction Labor Augmentation Labor Pregnancy Calcium Carbonate

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators think that calcium carbonate can act as an assistive medication to improve contractions during labor.

Official Title

Calcium Carbonate to Augment Labor Contractions

Quick Facts

Study Start:2024-11-18

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06580782

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Ester Sanchez, BSN

CONTACT

212-746-2106

ess4006@med.cornell.edu

Principal Investigator

Moeun Son, MD

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

Moeun Son, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-18

Study Completion Date2025-09

Study Record Updates

Study Start Date2024-11-18

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

Labor
Pregnancy
Labor Augmentation
Calcium Carbonate
labor induction

Additional Relevant MeSH Terms

Labor Dystocia
Labor Induction
Labor Augmentation