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Vaginal Misoprostol to Improve the Neonatal Respiratory Outcome

2018年1月4日 更新者:Ahmed Makhlouf、Assiut University

Vaginal Misoprostol Before Elective Cesarean Section to Improve Neonatal Respiratory Outcomes . Randomized Controlled Clinical Study

Project summary:

Objective: To test the hypothesis that administration of vaginal Misoprostol before elective cesarean section will improve the neonatal respiratory outcomes in late preterm and early term neonates through induction of catecholamine surge.

Design: Randomized controlled clinical trial. Setting: Women health center ,Assiut university hospital. Patients: mothers planned for cesarean section at 34 - 37weeks. Intervention: two hundred and ninety two women will be randomly allocated to receive either 50 micrograms of Misoprostol per vagina within one hour before cesarean section (study group; n= 146) or receive nothing (control group; n = 146) .

Main outcome measure: Apgar score at 1 and 5 minutes.

研究概览

地位

未知

详细说明

Methodology: After a written informed consent obtained, women who are fitting the inclusion criteria will be randomly allocated using sealed, coded, opaque and sequentially numbered envelopes containing computer generated random numbers into either the study group or the control group. For the study group the enrolled women will receive 50 microgram misoprostol vaginally within 60 minutes before CS. For the control group mothers enrolled will receive nothing.

Observation and data collection: Cardiotocographic monitoring will be undertaken after maternal misoprostol administration to detect any evidence of uterine hyperstimulation and fetal distress.

Ritodrine IV will be used as a tocolytic agent in case of uterine tachysystole. 100 mg of ritodrine will be added to 500 ml of 0.5% dextrose, the solution will be administered as following:

5 drops / minute in the 1st 10 minutes. 10 drops / minute in the next 10 minutes then 15 drops / minute . The clinician should adjust the infusion rate so that the pulse rate doesn't exceed 120b/min and lung bases are free of crepitations.

The surgical and anesthetic teams will be in a state of complete readiness for the ECS from the time of maternal misoprostol administration after enrollment. Details on maternal fluid-electrolyte status during ECS will be recorded as maternal fluid overload is reported to be associated with respiratory distress in the newborn. (SinghiS,Chookang E;1984) blood loss during and 1 hour after the operation will be estimated.

Maternal data: Patient name, hospital number, age, parity, gestational age, any medical disorder and indication of CS.

Neonatal observations: delivery room care details will be noted, neonatal heart rate, respiratory rate, and signs of respiratory distress- for example, grunting, chest wall retractions, nasal flaring- will be recorded hourly in the postnatal ward for eight hours and once only at 24 hours of age after delivery. Management of a neonate with respiratory distress (defined as respiratory rate at rest.60/min and/or signs of respiratory distress) will be left to the neonatal team. Severity of illness, provisional and final diagnosis, and outcome (death/discharge home/transfer to other hospital) will be recorded if any neonate would be admitted to the neonatal intensive care unit for respiratory distress.

研究类型

介入性

注册 (预期的)

292

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Assiut、埃及
        • 招聘中
        • women health center,Assiut university
        • 接触:

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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

All pregnant women who are planned for elective (planned& pre labor) cesarean section at 34 -37 weeks gestation.

Exclusion Criteria:

  1. Pregnancies with known fetal malformation/s or chromosomal aberrations.
  2. Presence of absolute contraindication for use of misoprostol.(i.e known hypersensitivity to the drug)
  3. Women before 34 and after 37 weeks gestation .
  4. Non reassuring cardiotocogram immediately before recruitment.
  5. multiple pregnancies.

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

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:study group
For the study group the enrolled women will receive 50 microgram misoprostol vaginally 60 minutes before CS
其他名称:
  • 前列腺素E1、Cytotec
无干预:control group
For the control group mothers enrolled will receive nothing.

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
1- Rate of Neonatal Intensive Care Unit admission for neonatal respiratory distress.
大体时间:During the first 24 hours of life.
The number of neonates who need Neonatal Intensive Care Unit admission in each study group
During the first 24 hours of life.

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。

调查人员

  • 首席研究员:Ahmed Makhlouf, professor、women health center,Assiut university,Assiut,Egypt

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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 (实际的)

2016年6月1日

初级完成 (预期的)

2018年1月1日

研究完成 (预期的)

2018年1月1日

研究注册日期

首次提交

2017年7月30日

首先提交符合 QC 标准的

2017年8月1日

首次发布 (实际的)

2017年8月4日

研究记录更新

最后更新发布 (实际的)

2018年1月8日

上次提交的符合 QC 标准的更新

2018年1月4日

最后验证

2017年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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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