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临床试验/NCT03539562
NCT03539562已完成不适用

Therapeutic Rest to Delay Admission in Early Labor: A Prospective Study on Morphine Sleep

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2017年9月27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
已完成
入组人数
82
试验地点
1
主要终点
The proportion of women who were admitted in active labor (6 cm or greater cervical dilation).

研究概览

简要总结

This will be a prospective study on labor characteristics, and obstetric and neonatal outcomes in women who accept and women who decline morphine as a form of pain management in labor. The study will also investigate patient satisfaction with this form of analgesia. The participants will be those who accept morphine and promethazine and those who decline morphine and promethazine for pain control.

详细描述

Objective

Therapeutic rest in labor involves administration of parenteral analgesics in early or prodromal labor to relieve the patient's discomfort and allow for progression of labor while the patient rests. No prospective studies exist which examine the safety and clinical utility of therapeutic rest in early labor, and no published studies examine the potential benefits of therapeutic rest from the perspective of either patient satisfaction or cost-effectiveness. The investigators aim to determine whether therapeutic rest using morphine and promethazine is associated with variations in labor characteristics, or obstetric or neonatal outcomes as well as patient satisfaction with this form of pain management.

Methods: This will be a prospective cohort study. Women who are eligible for therapeutic rest (reactive non-stress test, normal amniotic fluid, in prodromal or early labor as defined by obstetric provider, and plan to discharge home after evaluation) will be recruited for the study. Participants will receive routine obstetric care by providers who are unaware of patient enrollment. A research assistant will then approach all participants in the postpartum period, prior to discharge from the hospital or with a phone call if permitted by the patient, to complete a questionnaire including patient satisfaction items. Chart review will be performed to determine differences in hospital stay and common obstetric and neonatal outcomes to compare these data among women who do and do not choose to receive therapeutic rest. These results will provide insight into a common clinical practice, helping to not only guide management at institutions where therapeutic rest is commonly utilized but also potentially encourage its initiation at hospitals were therapeutic rest is not available.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancies between 37w0d and 41w6d gestation
  • Presentation to triage for rule out labor as primary indication and found to be in early labor
  • Offered therapeutic rest by obstetric provider with plan to discharge home after evaluation

排除标准

  • Allergy to morphine sulfate or promethazine
  • Being without an attendant to safely transport the patient home
  • Present to triage for other indication (decreased fetal-movement, premature rupture of membranes, hypertension, etc.)
  • Multiple gestation
  • Known fetal anomaly
  • Placenta previa, active maternal Herpes Simplex Virus disease, or any other contraindication to vaginal delivery
  • Recommendation for direct admission to L&D for maternal or fetal indication.

研究组 & 干预措施

Accepted Morphine Sulfate

Patients accepted morphine and promethazine as a method for pain management in early or prodromal labor.

干预措施: Morphine Sulfate and Promethazine (Drug)

结局指标

主要结局

The proportion of women who were admitted in active labor (6 cm or greater cervical dilation).

时间窗: 0 hours to 2 weeks

Admission in active labor

次要结局

  • Time in hours between the start of contractions to being offered therapeutic rest(1-2 weeks after delivery)
  • Type of delivery(1-2 weeks after delivery)
  • Proportion of newborns admitted to Intensive Care Nursery(1-2 weeks after birth)
  • Time in hours between being offered therapeutic rest and admission to labor and delivery(1-2 weeks after delivery)
  • Time in hours between admission to labor and delivery and complete cervical dilation(1-2 weeks after delivery)
  • Time in hours between complete cervical dilation and birth time(1-2 weeks after delivery)
  • Proportion of women who required augmentation of labor(1-2 weeks after delivery)
  • Time in hours between admission to labor and delivery and birth time(1-2 weeks after delivery)
  • Proportion of women who required induction of labor(1-2 weeks after delivery)
  • Proportion of women who received an epidural(1-2 weeks after delivery)
  • Proportion of women diagnosed with chorioamnionitis(1-2 weeks after delivery)
  • APGAR scores of neonate(1-2 weeks after birth)
  • Umbilical cord gas values(1-2 weeks after birth)
  • Neonatal Intensive Care Unit length of stay in days(1-2 weeks after birth)
  • Proportion of women with meconium present during labor(1-2 weeks after delivery)
  • Patient responses (yes or no) to a 4-question survey conducted after delivery to determine satisfaction with morphine and promethazine as a form of therapeutic rest.(1-4 weeks after delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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