跳至主要内容
临床试验/NCT06181396
NCT06181396招募中不适用

Association Between Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Mode of delivery

研究概览

简要总结

Early oxytocin administration at the 2nd stage of labor is associated with a higher rate of vaginal delivery, shorter second stage duration, and fewer adverse maternal and neonatal outcomes.

详细描述

Cesarean delivery (CD) is one of the most common surgeries performed worldwide. In the last few decades, its rate has steadily increased worldwide, leading to an increase in maternal morbidity and mortality compared to vaginal delivery (VD)1. In 2014, the American College of Obstetricians and Gynecologists (ACOG) and Society for Maternal Fetal Medicine (SMFM) published an Obstetric Care Consensus for safe prevention of primary cesarean delivery, allowing an additional hour of pushing during the 2nd stage of labor for both nulliparous and multiparous women before diagnosing prolonged 2nd of labor2-4.

Prolonged 2nd stage is especially common among nulliparous women5, and is defined as more than three hours of pushing6, or four hours for women with a regional anesthesia. Prolonged 2nd stage has been shown to be associated with maternal adverse outcomes, such as assisted-vaginal delivery, CD, and postpartum hemorrhage (PPH)7,8, and neonatal adverse outcomes such as low 5-minute Apgar score, and NICU admissions9.

Oxytocin is the primary and the most widely used pharmacological agent for induction and augmentation of labor10. Administrating oxytocin during labor is a common practice and is used to intensify contractions and decrease the chances of a non-progressive labor and associated adverse outcomes11,12. Despite its extensive use, there are several protocols which varies between different countries and obstetric wards. Likewise, there is no consensus regarding the duration or dosage of oxytocin infusion during labor, and especially during the 2nd stage of labor13.

The study will assess the optimal time initiation of Oxytocin during the 2nd stage of labor, and its association to mode of delivery, and adverse maternal and neonatal outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancy
  • Maternal age ≥ 18 years' old
  • Oxytocin administration initiated or renewed during second stage of labor

排除标准

  • Maternal age < 18 years' old
  • Multiple gestation pregnancy
  • Known fetal malformations
  • Uterine scar

研究组 & 干预措施

Immediate oxytocin

Experimental

This arm will receive oxytocin when entering 2nd stage (full dilation)

干预措施: Oxytocin (Drug)

Delayed oxytocin

Other

This arm will receive oxytocin one hour after entering 2nd stage (full dilation)

干预措施: Oxytocin (Drug)

结局指标

主要结局

Mode of delivery

时间窗: Delivery

Vaginal or instrumental or cesarean

次要结局

  • intrapartum fever(Delivery or 48 hours postpartum)
  • Postpartum hemorrhage(Delivery)
  • Neonatal pH(Delivery)
  • Neonatal Apgar score(Delivery)
  • Admission of the neonate to neonatal intensive care unit(Immediate postpartum, up to 5 days.)
  • 2nd stage duration(Delivery)
  • Meconium stain(Delivery)
  • FHR decelerations(Delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gal Bachar MD

Doctor of OBGYN

Rambam Health Care Campus

研究点 (1)

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