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Идёт набор NCT06580782

Calcium Carbonate to Augment Labor Contractions

Фаза IV С лечением Labor Dystocia Labor Induction Labor Augmentation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Calcium Carbonate 500 MG, Standard Dose Synthetic Pitocin.
Кому может быть актуально
Состояния в реестре: Labor Dystocia, Labor Induction, Labor Augmentation. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

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

Подробное описание

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.

Вмешательства

  • Препарат Calcium Carbonate 500 MG
    Calcium Carbonate 500mg, orally, every 4 hours.
  • Препарат Standard Dose Synthetic Pitocin
    The participant will receive thestandard-dose synthetic oxytocin for labor induction or augmentation.

Первичные конечные точки

  • Number of Participants Consented [Срок оценки: Day 0]
  • Number of Participants Enrolled [Срок оценки: Day 0]
  • Number of Participants that complete the Intervention as prescribed (Adherence) [Срок оценки: During hospitalization, approximately 5 days]
Вторичные конечные точки (10)
  • Duration of Labor (minutes) [Срок оценки: Approximately 5 days, length of hospitalization]
  • Mode of Delivery [Срок оценки: Approximately 5 days, length of hospitalization]
  • Number of Postpartum Hemorrhages [Срок оценки: Approximately 5 days, length of hospitalization]
  • Number of Treatment Related Adverse Events [Срок оценки: Approximately 6 weeks after delivery]
  • Neonatal health (APGAR Score) [Срок оценки: Approximately 5 days, length of hospitalization]
  • Neonatal health (Cord Blood Gases) [Срок оценки: Approximately 5 days, length of hospitalization]
  • Maternal Health (Number of Subject who experience PostPartum Fever) [Срок оценки: Approximately 5 days, length of hospitalization]
  • Practicality of Administering Calcium Carbonate, as measured by number of subjects who were administered the total prescribed intervention [Срок оценки: Approximately 5 days, length of hospitalization]
  • Race [Срок оценки: Day 0]
  • Ethnicity [Срок оценки: Day 0]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Weill Cornell Medicine — New York

Идентификаторы

NCT: NCT06580782 · 24-07027775

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗