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临床试验/NCT02411916
NCT02411916已完成不适用

Effect of Adjunctive Misoprostol on Blood Loss at Vaginal Delivery

New York City Health and Hospitals Corporation1 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2012年3月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
143
试验地点
1
主要终点
Change in Hemoglobin

研究概览

简要总结

This document defines the Clinical Investigation Protocol for a study designed to determine whether blood loss after spontaneous vaginal delivery is altered by the addition of misoprostol administration to the standard use of intravenous oxytocin after delivery. The protocol is an open-label randomized prospective trial to be carried out at Queens Hospital Center.

Blood loss will be measured indirectly by comparing the maternal hemoglobin and hematocrit levels on admission in labor to those obtained within 24 hours after delivery.

详细描述

Some maternal blood loss normally occurs at the time of vaginal delivery. The best estimates indicate that a loss of approximately 500 mL is average, with a range of about 250-700 mL.[1,2] Some of this bleeding arises from birth canal lacerations or surgical incisions (i.e., episiotomy), but most derives from the vessels exposed in the uterine wall at the placental site once the placenta has separated.

Under normal circumstances, shortly after placental separation intense myometrial contractions occur. These raise the pressure within the myometrial wall above that of the blood pressure in the vessels that traverse it, vessels that opened into the intervillous space. Flow in these vessels is thus mechanically attenuated by myometrial contraction, allowing for the formation of intravascular thrombi.

This mechanism for controlling postpartum uterine blood loss works well most of the time. If, however, the uterus remains hypotonic or atonic after delivery, excessive blood loss can occur. In the worst cases, severe uterine hemorrhage ensues. Postpartum hemorrhage is, in fact, the leading cause of maternal mortality in the world, accounting for at least 100,000 deaths annually.[3] Even in the absence of frank hemorrhage, postpartum blood loss can result in maternal anemia. Recuperation of iron stores to recover from this blood loss takes time, and may not occur, especially in low socioeconomic areas where dietary iron consumption is often deficient, and pregnancies tend to occur in close succession.

Postpartum anemia is a significant contributor to short- and long-term morbidity.[5-7] It increases the risk of infection and poor wound healing. Also, the associated fatigue may interfere with the mother's ability to administer child care and to bond appropriately with her infant. Anemic mothers tend to have more difficulty with nursing, and may produce iron-deficient milk. There is thus a strong rationale to minimize postpartum blood loss.

In most US hospitals, parturients receive a high dose of intravenous or intramuscular oxytocin immediately after delivery. This approach has been shown in several studies to reduce the risk of postpartum hemorrhage, [8-11] and is practiced routinely at Queens Hospital Center. Investigators will employ an intravenous infusion of oxytocin (Pitocin®) at a rate of about 50-100 mU/minute. Despite this approach, there is still substantial blood loss at delivery, based on the investigator's preliminary observations shown below. This provides the rationale to determine whether use of an adjunctive drug, namely misoprostol 600 µg rectally, administered after delivery, might reduce blood loss further than does oxytocin alone, thus decreasing the risk of morbidity related to postpartum anemia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •(A patient will be considered for inclusion in the study if she meets all of the following criteria):
  • •She has a term (≥37 completed weeks) live singleton gestation in cephalic presentation and has been admitted to the Labor and Delivery Unit
  • •She is in the latent phase of labor or has been admitted for induction of labor or at prenatal clinic visit
  • •She has had fewer than four prior vaginal deliveries.
  • •She reports no allergy to misoprostol.
  • •The following factors or conditions will exclude a patient from consideration as a subject:
  • •The fetus has a known major fetal malformation or chromosome abnormality
  • •The gestation is multiple.
  • •There is a breech or other malpresentation
  • •The patient reports involvement in another clinical trial currently or previously in this pregnancy.
  • •The patient is expected to have a cesarean delivery.
  • •The patient had a prior cesarean delivery.
  • •There has been an intrauterine fetal death.
  • •There is polyhydramnios (amniotic fluid index >22 cm).
  • •Presence of acute or chronic renal disease
  • •Presence of preeclampsia

排除标准

  • •(Of subjects who enter the study, the development of certain conditions will exclude them post hoc from receiving misoprostol under the protocol, and from the data analysis. These conditions include):
  • •Unanticipated cesarean delivery.
  • •Performance of episiotomy (third and fourth degree extensions will be excluded).
  • •Vaginal or cervical laceration, or perineal laceration of more than second degree in depth.
  • •Severe postpartum hemorrhage requiring intervention immediately after delivery.
  • •Uterine rupture
  • •Placental abruption.
  • •Patient withdrawal of consent.

研究组 & 干预措施

controls

No Intervention

patients not receiving misoprostol

intervention cases

Experimental

patient receiving misoprostol

干预措施: misoprostol (Biological)

结局指标

主要结局

Change in Hemoglobin

时间窗: 1 day after delivery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleksandr Fuks

Directore, Department OB / GYN , Queens Hospital Center

New York City Health and Hospitals Corporation

研究点 (1)

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