Uterotonics Using to Reduce Bleeding at Cesarean Section
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Assiut University
临床试验: NCT02562300
BioSeek: NCT02562300
关键词
抽象
Postpartum haemorrhage continues to be a leading cause of maternal morbidity and mortality worldwide and that is according to the estimates of the World Health Organization in 1998. Average blood loss during delivery progressively increases with the type of delivery, vaginal delivery (500 ml), cesarean section (1000 ml) and emergency hysterectomy (3500 ml) of blood.
A reduction of operative blood loss at cesarean section has a great benefit to the patients in terms of decreased postoperative morbidity and a decrease in risks associated with blood transfusions. The routine use of oxytocin is associated with a significant reduction in the occurrence of postpartum hemorrhage.
Excessive blood loss as estimated by a 10% drop in the hematocrit value postdelivery or by need for blood transfusion, occurs in approximately 4% of vaginal deliveries and 6% of cesarean births.
Although many delivery units use oxytocin as the first line agent to prevent uterine atony at cesarean section, it may not be the ideal agent for prevention of postpartum haemorrhage especially in compromised patients with preeclampsia, cardiac disease or prolonged labor. Oxytocin and specifically its preservative chlorobutanol increases the heart rate and has negative inotropic, antiplatelet and antidiuretic effects.
Misoprostol, a prostaglandin E1 analogue, has been shown in many studies to be an effective myometrial stimulant of the pregnant uterus which binds to prostanoid receptors.
Misoprostol administration, either by oral or rectal route, has been shown to be effective in prevention of postpartum haemorrhage and is considered as an effective alternative to other conventional oxytocics especially in developing countries as it is cheap and thermostable.
Pharmacokinetic studies suggested that the bioavailability of misoprostol after sublingual administration was higher than those after oral or vaginal administration.
A few studies are now available for the use of sublingual misoprostol in the prevention of postpartum haemorrhage following vaginal delivery and have reported it as an effective and convenient route of administration.
However, none of the studies conducted so far have evaluated the response of sublingual misoprostol for prevention of postpartum haemorrhage during cesarean section.
日期
最后验证: | 12/31/2013 |
首次提交: | 09/26/2015 |
提交的预估入学人数: | 09/26/2015 |
首次发布: | 09/28/2015 |
上次提交的更新: | 09/26/2015 |
最近更新发布: | 09/28/2015 |
实际学习开始日期: | 12/31/2013 |
预计主要完成日期: | 12/31/2014 |
预计完成日期: | 03/31/2015 |
状况或疾病
Postpartum Haemorrhage
干预/治疗
Drug: Sublingual misoprostol
Drug: oxytocin
相
相 2
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: Sublingual misoprostol The patients in this arm received 400 micrograms of sublingual misoprostol, immediately after delivery of the neonate. | Drug: Sublingual misoprostol 400 micrograms of sublingual misoprostol were given immediately after delivery of the neonate. |
Active Comparator: oxytocin The patients in this arm received 20 IU oxytocin dissolved in 1 L of Lactated Ringer's or glucose solution) at the rate of 125 ml /h , immediately after delivery of the neonate. | Drug: oxytocin 20 IU oxytocin dissolved in 1 L of Lactated Ringer's or glucose solution) at the rate of 125 ml /h were given immediately after delivery of the neonate. |
资格标准
有资格学习的年龄 | 20 Years 至 20 Years |
有资格学习的性别 | Female |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Gestational age 37-40 wk. - Elective lower segment cesarean section. - Under spinal anesthesia. Exclusion Criteria: - Anemia (Hb> 8 g%). - Multiple gestation. - Antepartum hemorrhage. - Poly-hydramnios. - Two or more previous cesarean sections. - History of previous rupture uterus. - Current or previous history of significant disease including heart disease, liver, renal disorders or known coagulopathy. |
结果
主要结果指标
1. Blood loss in ML [1 year]
次要成果指标
1. Hematocrit value (%) [1 year]