Ideal Time of Oxytocin Infusion During Cesarean Section (I-TOPICS)
2020年6月16日 更新者：Loyola University
This study will evaluate if the timing of oxytocin administration in cesarean deliveries will affect the amount of maternal blood loss.
Half of participants will receive oxytocin after delivery of the fetal anterior shoulder and the other half will receive oxytocin after delivery of the placenta.
We hypothesize that administering oxytocin after delivery of the shoulder, will result in less overall maternal blood loss.
研究概览
详细说明
Oxytocin is a routinely administered medication for both vaginal and cesarean deliveries in the third stage of labor, as part of standard of care in the United States. This medication helps to reduce overall blood loss, by functioning as a uterotonic. Currently evidence is lacking to direct timing of oxytocin administration in cesarean deliveries.
This study will evaluate both estimated and quantitative blood loss for both groups of patients. It will also compare the change from pre-operative to post-operative hemoglobin levels.
研究类型
介入性
注册 (实际的)
68
阶段
- 第四阶段
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
-
-
Illinois
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Maywood、Illinois、美国、60153
- Loyola University Medical Center
-
-
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
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- Women undergoing cesarean section at Loyola Hospital
- Women who read and speak the English and/or Spanish language
- Women age 18 or older
Exclusion Criteria:
- Women who deliver vaginally
- Gestation under 37 weeks and 0 days
- Women with coagulopathies
- Multiple gestation pregnancies
- Antepartum hemorrhage for example abruption
- Placental abnormalities for example previa, accreta
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Control (Group A)
One bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia when the fetal anterior shoulder delivers.
After the placenta is delivered, then one bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia.
This amount of fluid is part of standard of care.
|
Placebo will be administered after delivery of the placenta
|
|
有源比较器：Intervention (Group B)
One bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia when the fetal anterior shoulder delivers.
After the placenta is delivered, then one bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia.
This amount of fluid is part of standard of care.
|
Oxytocin is administered after delivery of the fetal anterior shoulder, rather than being administered after delivery of the placenta
其他名称：
|
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 blood loss
大体时间：At the completion of the surgery when patient is transferred to recovery from the operating room
|
Both the estimated blood loss and quantitative blood loss will be determined
|
At the completion of the surgery when patient is transferred to recovery from the operating room
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of postpartum hemorrhage
大体时间：At the completion of the surgery when patient is transferred to recovery from the operating room
|
The number of women who lose 1,000 milliliters or more blood from cesarean delivery
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At the completion of the surgery when patient is transferred to recovery from the operating room
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Need for transfusion
大体时间：In the immediate 24 hours post surgery
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The number of women who require a blood transfusion due to surgical blood loss
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In the immediate 24 hours post surgery
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Change in pre-operative to post-operative hemoglobin levels
大体时间：Baseline and Post operative day number 1
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Hemoglobin levels
|
Baseline and Post operative day number 1
|
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：Thaddeus Waters, MD、Loyola University
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。
一般刊物
- Soltani H, Hutchon DR, Poulose TA. Timing of prophylactic uterotonics for the third stage of labour after vaginal birth. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD006173. doi: 10.1002/14651858.CD006173.pub2.
- Dahlke JD, Mendez-Figueroa H, Rouse DJ, Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery: an updated systematic review. Am J Obstet Gynecol. 2013 Oct;209(4):294-306. doi: 10.1016/j.ajog.2013.02.043. Epub 2013 Mar 1.
- Jackson KW Jr, Allbert JR, Schemmer GK, Elliot M, Humphrey A, Taylor J. A randomized controlled trial comparing oxytocin administration before and after placental delivery in the prevention of postpartum hemorrhage. Am J Obstet Gynecol. 2001 Oct;185(4):873-7. doi: 10.1067/mob.2001.117363.
- WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK131942/
- Oguz Orhan E, Dilbaz B, Aksakal SE, Altinbas S, Erkaya S. Prospective randomized trial of oxytocin administration for active management of the third stage of labor. Int J Gynaecol Obstet. 2014 Nov;127(2):175-9. doi: 10.1016/j.ijgo.2014.05.022. Epub 2014 Jul 17.
- Fidan U, Keskin U, Ulubay M, Efendi Karaca R, Burcin Firatligil F, Goksen Kocagoz G, Ergun A. The effect of the use of oxytocin on blood loss during different postpartum periods. J Perinat Med. 2015 Jul;43(4):461-5. doi: 10.1515/jpm-2014-0111.
- Khan FA, Khan M, Ali A, Chohan U. Estimation of blood loss during Caesarean section: an audit. J Pak Med Assoc. 2006 Dec;56(12):572-5.
- Anderson JM, Etches D. Prevention and management of postpartum hemorrhage. Am Fam Physician. 2007 Mar 15;75(6):875-82.
- National Collaborating Centre for Women's and Children's Health. Caesarean section NICE Clinical Guideline. Royal College of Obstetricians and Gynaecologists
- Silverman, F. & Bornstein, E. Pharmacologic management of the third stage of labor. UpToDate. 2015
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)
2017年9月13日
初级完成 (实际的)
2020年2月24日
研究完成 (实际的)
2020年2月24日
研究注册日期
首次提交
2017年8月4日
首先提交符合 QC 标准的
2017年8月8日
首次发布 (实际的)
2017年8月11日
研究记录更新
最后更新发布 (实际的)
2020年6月18日
上次提交的符合 QC 标准的更新
2020年6月16日
最后验证
2019年8月1日
更多信息
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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