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Correlation Between the Polymorphism ofβ2 AR and the Labor Progress After Labor Analgesia

2016年3月16日 更新者:Caijuan Li、Nanjing Maternity and Child Health Care Hospital

Principal Investigator

Labor and delivery is a unique physiological experience of women. Inappropriate length of labor progress during vaginal delivery may produce great risks for mother and fetus. Especially the slow progress is one of the most important reasons for the occurrence of cesarean section during vaginal delivery, which still with a high incidence in recent years.Previous studies have found that there was a significant correlation between the genetic polymorphisms of β 2-adrenergic receptor (β2AR) and the duration of vaginal delivery.Therefore, the researchers intend to investigate the distribution of β2-adrenergic receptor (β2AR) genetic polymorphisms among Chinese parturient and observe the relationship between the genetic polymorphisms and labor process after labor analgesia.

研究概览

地位

未知

条件

研究类型

观察性的

注册 (预期的)

300

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

23年 至 43年 (成人)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

概率样本

研究人群

The parturient undergoing labor analgesia in our hospital. And the eligible parturient aged at 23-43, gestational age 35-42 weeks with an ASA grade I-II, who spontaneously choosing vaginal delivery mode with epidural analgesia.

描述

Inclusion Criteria:

  • Nulliparous women
  • Required labor analgesia
  • Chinese
  • Spontaneous labor

Exclusion Criteria:

  • Contraindications for epidural analgesia
  • Allergic to opioids and/or local anesthetics
  • Failed to performing epidural catheterization
  • Organic dysfunction
  • Those who were not willing to or could not finish the whole study at any time
  • Using or used in the past 14 days of the monoamine oxidase inhibitors
  • Alcohol addictive or narcotic dependent patients
  • Subjects with a nonvertex presentation or scheduled induction of labor
  • Twin gestation and breech presentation

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
β2AR Arg16Arg (AA group)
People with β2AR Arg16Arg genotype.
β2AR Arg16Gly (AG group)
People with β2AR Arg16Gly genotype.
β2AR Gly16Gly (GG group)
People with β2AR Gly16Gly genotype.
β2AR Gln27Gln (CC group)
People with β2AR Gln16Gln genotype.
β2AR Gln27Glu (CG group)
People with β2AR Gln27Glu genotype.
β2AR Glu27Glu (GG group)
People with β2AR Glu27Glu genotype.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
total labor process
大体时间:up to about 24h
time from the regular uterus contractions until completed childbirth, assessed up to about 24h
up to about 24h
duration of the first stage
大体时间:up to about 20h
time from the regular uterus contractions to full cervix dilation,assessed up to about 20h
up to about 20h
duration of the second stage
大体时间:up to about 2h
time from full cervix dilation to the complete childbirth, assessed up to about 2h
up to about 2h
Maternal visual analogue scale
大体时间:At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)

次要结果测量

结果测量
措施说明
大体时间
method of delivery
大体时间:At time of placental delivery
At time of placental delivery
At time of placental delivery
Maternal modified Bromage scale
大体时间:At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture
大体时间:At two hours postpartum
At two hours postpartum
At two hours postpartum
Maternal satisfaction with analgesia
大体时间:At two hours postpartum
At two hours postpartum
At two hours postpartum
Use of oxytocin after analgesia
大体时间:At twenty-four hours postpartum
At twenty-four hours postpartum
At twenty-four hours postpartum
Neonatal Apgar scale
大体时间:At the first and fifth minutes after baby was born
At the first and fifth minutes after baby was born
At the first and fifth minutes after baby was born
Maximal oxytocin dose
大体时间:At twenty-four hours postpartum
At twenty-four hours postpartum
At twenty-four hours postpartum
Maternal heart rate, respiratory rate, and blood pressure
大体时间:At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Neonatal weight
大体时间:At delivery
At delivery
At delivery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年3月1日

初级完成 (预期的)

2016年4月1日

研究完成 (预期的)

2016年5月1日

研究注册日期

首次提交

2016年2月18日

首先提交符合 QC 标准的

2016年3月9日

首次发布 (估计)

2016年3月15日

研究记录更新

最后更新发布 (估计)

2016年3月17日

上次提交的符合 QC 标准的更新

2016年3月16日

最后验证

2016年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • NMCHC2016003

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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