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Идёт набор NCT06199154

Induction of Labor in Morbidly Obese Patients

Ранняя фаза I С лечением Morbid Obesity Pregnancy

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: Misoprostol.
Кому может быть актуально
Состояния в реестре: Morbid Obesity, Pregnancy. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Induction of Labor in Morbidly Obese Patients: Comparison of 50 mcg and 25 mcg Misoprostol - A Randomized Control Trial

Обзор

The goal of this randomized control trial is to compare different doses of Misoprostol (25 mcg vs 50 mcg) in induction of labor (IOL) in morbidly obese patients with BMI \>40. It is known that morbid obesity is a risk factor for failed IOL and ultimately cesarean delivery (CD.) If the rates of vaginal delivery in this population can improve, then surgical morbidity can be reduced in these patients.

Подробное описание

The rate of IOL continues to increase, from about 10% in 1990 to 23% in 2018. Patients with BMI \>40 are at increased risk for failed IOL and needing a CD. Studies show that morbidly obese patients require higher doses of pitocin and multiple agents to achieve vaginal delivery, but optimal dosing of misoprostol has not been studied as well. Increasing the rate of vaginal delivery in this population will help decrease risk of surgical morbidity.

The investigators plan to conduct a randomized controlled double blinded trial. Patients who are scheduled for induction of labor after 34 weeks gestation, have a BMI \>40, and meet all study inclusion criteria will be approached by research personnel during their outpatient appointments. Participants will be randomized to either receive 25 mcg vaginal misoprostol every 4 hours or 50 mcg vaginal misoprostol every 4 hours.

Вмешательства

  • Препарат Misoprostol
    Participants will receive with 25 mcg or 50 mcg vaginal misoprostol every 4 hours.

Первичные конечные точки

  • Achievement of complete cervical dilation [Срок оценки: Start of IOL until complete dilation]
Вторичные конечные точки (12)
  • Time interval from start of induction of labor (IOL) to complete cervical dilation [Срок оценки: Start of IOL until complete dilation]
  • Achievement of 6 cm cervical dilation/active labor [Срок оценки: Start of IOL until 6 cm dilation]
  • Time interval from start of IOL to 6 cm cervical dilation/active labor [Срок оценки: Start of IOL until 6 cm dilation]
  • Time interval from start of IOL to vaginal delivery [Срок оценки: Start of IOL until delivery]
  • Time interval from start of IOL to delivery [Срок оценки: Start of IOL until delivery]
  • Incidence of vaginal deliveries [Срок оценки: Start of IOL until delivery]
  • Incidence of cesarean deliveries [Срок оценки: Start of IOL until delivery]
  • Indication for cesarean delivery [Срок оценки: Start of IOL until delivery]
  • Cervical exam at time of cesarean delivery [Срок оценки: Start of IOL until delivery]
  • Number of patients with tachysystole [Срок оценки: Start of IOL until delivery]
  • Number of patients with tachysystole with non reassuring fetal heart rate (NRFHT) [Срок оценки: Start of IOL until delivery]
  • Number of patients requiring terbutaline [Срок оценки: Start of IOL until delivery]

Критерии участия

Критерии включения

  • Morbidly obese (BMI ≥ 40 kg/m2) at admission for induction of labor
  • Speaks English or Spanish
  • Gestational age between 34 weeks and 0 days and 42 weeks and 6 days
  • Age 18 years old or older
  • Viable, single, cephalic fetus
  • Intent to proceed with cervical ripening - cervical exam: dilation < 5 cm
  • Contractions < 5 per 10 minutes

Критерии исключения

  • History of cesarean delivery
  • Contraindication to prostaglandin administration (significant myomectomy, prior cesarean delivery)
  • Contraindication to vaginal delivery (placenta previa, vasa previa, HIV with high viral load)
  • Contraindications to labor (cardiac, neurosurgical, need for cesarean)
  • Age < 18yo
  • Fetal growth restriction with abnormal umbilical artery Doppler indices
  • Cervical dilation >5 cm
  • Contractions >5 per 10 minutes
  • Significant vaginal bleeding with concern for placental abruption
  • Non-reassuring fetal status or fetal heart rate decelerations
  • Fetal demise or major fetal anomaly
  • Inability to give consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Maryland Medical Center — Baltimore

Публикации

  • Hoyert, Donna L. "Maternal Mortality Rates in the United States, 2021." Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 16 Mar. 2023, www.cdc.gov/nchs/data/hestat/maternal-mortality/2021/maternal-mortality-rates-2021.htm.
  • MarchofDimes. "Total Cesarean Deliveries by Maternal Race/Ethnicity: United States, 2019-2021 Average." March of Dimes | PeriStats, www.marchofdimes.org/peristats/data?reg=99&top=8&stop=356&lev=1&slev=1&obj=1. Accessed 14 Nov. 2023.
  • "Adult Obesity Facts." Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 17 May 2022, www.cdc.gov/obesity/data/adult.html.
  • Ellis JA, Brown CM, Barger B, Carlson NS. Influence of Maternal Obesity on Labor Induction: A Systematic Review and Meta-Analysis. J Midwifery Womens Health. 2019 Jan;64(1):55-67. doi: 10.1111/jmwh.12935. Epub 2019 Jan 16. PMID 30648804
  • Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management PMID 30089070
  • Beckwith L, Magner K, Kritzer S, Warshak CR. Prostaglandin versus mechanical dilation and the effect of maternal obesity on failure to achieve active labor: a cohort study. J Matern Fetal Neonatal Med. 2017 Jul;30(13):1621-1626. doi: 10.1080/14767058.2016.1220523. Epub 2016 Aug 25. PMID 27560557
  • O'Dwyer V, O'Kelly S, Monaghan B, Rowan A, Farah N, Turner MJ. Maternal obesity and induction of labor. Acta Obstet Gynecol Scand. 2013 Dec;92(12):1414-8. doi: 10.1111/aogs.12263. PMID 24116732
  • Pevzner L, Powers BL, Rayburn WF, Rumney P, Wing DA. Effects of maternal obesity on duration and outcomes of prostaglandin cervical ripening and labor induction. Obstet Gynecol. 2009 Dec;114(6):1315-1321. doi: 10.1097/AOG.0b013e3181bfb39f. PMID 19935035

Идентификаторы

NCT: NCT06199154 · HP-00108436

Первоисточники (государственные реестры)

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