Routine Activity and Preterm Delivery Risk in Women With a Short Cervix
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: Maximal Rest.
- Кому может быть актуально
- Состояния в реестре: Cervical Shortening. Базовые параметры: Без ограничений · 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
- Израиль
- 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
The Effect of Routine Activity on the Risk for Preterm Delivery in Women With a Short Cervix. A Randomized Control Trial
Обзор
The goal of this clinical trial is to evaluate the effect of routine activity versus rest on the risk of preterm delivery in pregnant women with a short cervix diagnosed between 24 and 34 weeks of gestation. The main questions it aims to answer are: Does routine activity influence the gestational age at delivery? How does routine activity affect secondary outcomes such as preterm labor, premature rupture of membranes, delivery mode, maternal anxiety, and satisfaction? Researchers will compare women instructed to maintain routine activity (control group) to women advised to practice maximal rest (intervention group) to see if physical activity impacts preterm birth outcomes. Participants will: Wear a smart band to monitor step counts over a two-week period. Be randomized into two groups: one encouraged to maintain routine activity and the other advised to follow strict rest protocols. Undergo regular follow-ups at a high-risk pregnancy clinic and have their data collected through hospital records and smart band tracking. This randomized controlled trial will assess gestational age at delivery as the primary outcome, along with secondary maternal and neonatal outcomes, providing insight into the role of physical activity in managing pregnancies complicated by a short cervix.
Вмешательства
- Поведенческое Maximal Rest
Participants in this group are instructed to follow maximal rest protocols. They are advised to avoid strenuous activities, including prolonged standing, lifting heavy objects, or engaging in physically demanding tasks. This group represents the traditional bed rest approach to managing pregnancies with a short cervix.
Первичные конечные точки
- gestational age at delivery [Срок оценки: two years]
Вторичные конечные точки (3)
- Rates of preterm labor. [Срок оценки: two years]
- Incidence of premature rupture of membranes (PPROM). [Срок оценки: two years]
- Mod of delivery (cesarean, instrumental, or spontaneous). [Срок оценки: two years]
Критерии участия
Критерии включения
- Singleton pregnancies between 24+0 and 34+6 weeks.
- Short cervical length (<25 mm) confirmed via transvaginal ultrasound.
- No medical contraindications to physical activity.
Критерии исключения
- Twin pregnancies or higher-order multiples.
- Medical indications for reduced mobility (e.g., symphysiolysis, fall risk).
- Maternal comorbidities, fetal distress, vaginal bleeding, PPROM, or need for immediate delivery.
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
- Открытое
- Основная цель
- Профилактика
Центры проведения
Израиль · 1 центр
- The Edith Wolfson Medical Center — Holon
Публикации
- Zemet R, Schiff E, Manovitch Z, Cahan T, Yoeli-Ullman R, Brandt B, Hendler I, Dorfman-Margolis L, Yinon Y, Sivan E, Mazaki-Tovi S. Quantitative assessment of physical activity in pregnant women with sonographic short cervix and the risk for preterm delivery: A prospective pilot study. PLoS One. 2018 Jun 11;13(6):e0198949. doi: 10.1371/journal.pone.0198949. eCollection 2018. PMID 29889906
- Grobman WA, Gilbert SA, Iams JD, Spong CY, Saade G, Mercer BM, Tita ATN, Rouse DJ, Sorokin Y, Leveno KJ, Tolosa JE, Thorp JM, Caritis SN, Peter Van Dorsten J; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Activity restriction among women with a short cervix. Obstet Gynecol. 2013 Jun;121(6):1181-1186. doi: 10.1 PMID 23812450
- Sosa CG, Althabe F, Belizan JM, Bergel E. Bed rest in singleton pregnancies for preventing preterm birth. Cochrane Database Syst Rev. 2015 Mar 30;2015(3):CD003581. doi: 10.1002/14651858.CD003581.pub3. PMID 25821121
- Teitelman AM, Welch LS, Hellenbrand KG, Bracken MB. Effect of maternal work activity on preterm birth and low birth weight. Am J Epidemiol. 1990 Jan;131(1):104-13. doi: 10.1093/oxfordjournals.aje.a115463. PMID 2293743
- Maloni JA. Antepartum bed rest for pregnancy complications: efficacy and safety for preventing preterm birth. Biol Res Nurs. 2010 Oct;12(2):106-24. doi: 10.1177/1099800410375978. PMID 20798159
- Goldenberg RL, Cliver SP, Bronstein J, Cutter GR, Andrews WW, Mennemeyer ST. Bed rest in pregnancy. Obstet Gynecol. 1994 Jul;84(1):131-6. PMID 8008308
- Berghella V, Saccone G. Cervical assessment by ultrasound for preventing preterm delivery. Cochrane Database Syst Rev. 2019 Sep 25;9(9):CD007235. doi: 10.1002/14651858.CD007235.pub4. PMID 31553800
- Navathe R, Saccone G, Villani M, Knapp J, Cruz Y, Boelig R, Roman A, Berghella V. Decrease in the incidence of threatened preterm labor after implementation of transvaginal ultrasound cervical length universal screening. J Matern Fetal Neonatal Med. 2019 Jun;32(11):1853-1858. doi: 10.1080/14767058.2017.1421166. Epub 2018 Jan 5. PMID 29303014
Идентификаторы
NCT: NCT06884761 · 124-24-WOMC