Impact of Standardization on Outcomes Following Cervical Ripening

Обзор

The primary purpose of this study is to determine if vaginal delivery rate is impacted by the use of standardized methods of cervical ripening. Additional outcomes will be evaluated including maternal and fetal outcomes of labor.

Подробное описание

The goal of this study is to evaluate the impact of standardization of cervical ripening on labor outcomes as well as to evaluate whether different methods of cervical ripening influence labor outcomes The primary outcome will be SVD rate. Secondary outcomes will include time from admission to delivery, total duration of hospitalization (admission to discharge), operative vaginal delivery rate, incidence of delivery within 24 hours of admission, maximal dose of oxytocin (in mU/min), incidence of tachysystole requiring intervention, incidence of intervention for fetal bradycardia or "non-reassuring fetal status", maternal morbidity (endometritis, 3rd or 4th degree lacerations, hemorrhage \>1000mL, blood transfusion, wound separation or infection or readmission), neonatal length of stay\>3 days, NICU admission.

Вмешательства

• Устройство Cervical Ripening with a double balloon catheter only
  Labor induction will include cervical ripening with the use of a double balloon catheter without medication at the same time. After the balloon comes out (is taken out or falls out), the rest of the labor course will be managed by your provider
• Комбинированный продукт Cervical ripening with a double balloon catheter plus misoprostol
  The labor induction will include cervical ripening with the use of a double balloon catheter and the medication misoprostol at the same time. After the balloon comes out (is taken out or falls out), the rest of your labor course will be managed by the provider.
• Комбинированный продукт Usual-care control group
  Cervical ripening will occur using the method chosen by the provider as part of standard clinical care. This may include the use of a double balloon catheter, misoprostol, both, or other methods commonly used for induction of labor.

Первичные конечные точки

• SVD rate [Срок оценки: From enrollment until delivery, up to four days]

Вторичные конечные точки (11)

• SVD rate for study arm 1 versus study arm 2 (% difference) [Срок оценки: From enrollment until delivery, up to four days]
• Incidence of delivery within 24 hours of admission [Срок оценки: Enrollment until delivery, up to four days]
• Incidence of tachysystole requiring intervention [Срок оценки: Enrollment until study completion, up to 94 days]
• Incidence of intervention for fetal bradycardia or "non reassuring fetal status" [Срок оценки: Enrollment until study completion, up to 94 days]
• Rate of Maternal endometritis [Срок оценки: Enrollment until study completion, up to 94 days]
• Composite maternal morbidity [Срок оценки: From delivery until 30 days after delivery]
• neonatal length of stay >3 days [Срок оценки: From delivery until 3 days post delivery]
• Rate of NICU admission [Срок оценки: From delivery until study completion, up to 94 days]
• Quantitative Blood Loss [Срок оценки: From delivery until discharge, up to 4 days]
• Time from admission to delivery [Срок оценки: From admission until delivery, up to four days]
• Total duration of hospitalization [Срок оценки: From admission to discharge, up to 8 days]

Критерии участия

Критерии включения

• Patients who are scheduled for medically indicated or elective induction of labor with gestational age ≥37 weeks at Eskenazi hospital
• Willing and able to provide informed consent
• Age ≥18 years old
• Able to read, speak and understand English, Spanish or Haitian Creole

Критерии исключения

• Premature rupture of membranes
• Known chorioamnionitis
• Fetal malpresentation
• Placenta previa
• Category 3 fetal heart rate tracing -- only at the time of screening and enrollment. If a Category III tracing develops later in labor, this will prompt standard obstetric management, not removal from the study.
• Prior uterine scar (cesarean delivery or other contraindication to use of prostaglandins)
• Major fetal anomalies known at the time of enrollment that are expected to meaningfully impact labor management
• Multiple gestation
• Allergy to misoprostol or other contraindication to induction of labor or use of misoprostol or cook cervical ripening balloon
• Patient does not require cervical ripening (SBS ≥ 6 or dilation ≥ 4cm)
• Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study

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

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Sidney & Lois Eskenazi Hospital — Indianapolis

Идентификаторы

NCT: NCT07576881 · 27548

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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