Influence of Acupuncture in the Postpartum Blood Loss
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Postpartum blood loss
研究概览
简要总结
In this study, a single blind randomized trial with third party evaluation is carried out in order to compare the postpartum blood loss when Ren Mai 6 point is stimulated and when this point is not stimulated.
Investigators focus on measuring the volume of postpartum blood during the third stage of labor and during the first two hours after birth. A significant reduction in the volume of bleeding would imply a reduction in the rate of postpartum hemorrhage (PPH) (more than 500 ml) and the rate of severe PPH (more than 1000 ml).
The principal outcome of the study is the volume of postpartum blood, this volume is measured by the midwife who is responsible of the birth. Collection of lost blood is initiated immediately after birth of the baby by passing a blood collection drape under the woman's buttocks.
The secondary outcomes are the influence of acupuncture in the placental expulsion time, and the influence of the predictor variables in the bleeding volume and in the placental expulsion time: primiparity or multiparity, number of gestation including abortions, doses of oxytocin during labor, maternal age, maternal weight in the beginning of the gestation, maternal ponderal gain during pregnancy, date of the last blood test during pregnancy and value of hemoglobin and hematocrit, spontaneous labor or induction by means of oxytocin or prostaglandins, spontaneous or artificial rupture of membranes, first stage of labor duration, second stage of labor duration, hours since rupture of membranes, hours since epidural analgesia, volume of serotherapy during labor, and newborn weight. Possible puerperal complications or security problems, the degree of Satisfaction of the Mother and the degree of ease with which the acupuncturist administered the treatment are also secondary outcomes.
详细描述
This study is designed as a single-blind randomized clinical trial with parallel design, and third party evaluation at the Hospital Universitario Príncipe de Asturias in Alcalá de Henares (Madrid, Spain). The study will be carry out with pregnant women who were in labor at this hospital. Information sheets about the study will be distributed by the different health care centers coordinated by the hospital. The midwives will give the information sheets to pregnant women during the pregnancy's attendances. The objective is to let pregnant women know about the study before their labor date in order to encourage them to participate in it.
Pregnant women fulfilling all the inclusion criteria and none of the exclusion criteria will be invited to participate in the experiment. These requirements includes pregnant women from 18 to 40 years old, with eutectic delivery, gestation between 37 and 42 weeks, labors with epidural analgesia.
Concerning the procedure and data collection, the acupuncturist will request permission to midwife responsible of the mother for their collaboration in the study in the pre-labor room. The acupuncturist will explain the study to the mother and her partner and will apply for her voluntary participation being the informed consent offered then. All information will be given when the pregnant woman is without pain of labor, preferably when the woman is under the epidural analgesia effects.
Regarding to the selection of patients, a randomization scheme will be performed using an envelope based method. The researches will have opaque envelopes with a number outside, this number being the code of the patient in the study. After the approval of the pregnant woman and informed consent, the acupuncturist opens the envelop which will indicate the treatment to follow, either control or intervention group. So, investigators guarantee randomization, blindness and unpredictable selection of the sample.
In the labor ward, after delivery, the baby is placed on the abdomen of the puerperal mother to facilitate maternal link. Collection of lost blood is initiated immediately after birth of the baby by passing a blood collection bag under the woman's buttocks. The birth attendant clamps the umbilical cord at first minute after birth and the acupuncturist midwife performed the acupuncture procedure depending on the group assigned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women from 18 to 40 years old
- •Within 37 and 42 gestation weeks
- •Low obstetric risk labor
- •With epidural analgesia
排除标准
- •Pregnant woman with metal allergy
- •Patients with anticoagulant treatment
- •Dystocic labor
- •Uterine overdistension
- •Precipitous (less than 2 hours) or prolonged ( more than 11 hours) first stage of labor
- •Pregnant woman with coagulation disorders
- •Alterations in the placental insertion
- •Pregnant woman with curettage
- •Woman with previous uterine surgery or myomatosis
- •Use of uterine relaxants during labor
- •Patients who do not understand Spanish or are not be able to understand the procedure of the study or to sign the informed consent.
结局指标
主要结局
Postpartum blood loss
时间窗: First two hours after birth
This volume is measured by the midwife responsible of the birth who does not know if the point is punctured or not, thus guaranteeing the third party evaluation.
次要结局
- Placental Expulsion Time(First two hours after birth)
- Number of participants with puerperal complications(48 hours after birth)
- Degree of Satisfaction of the Mother(Two hours after labor)
- Degree of ease with which the technique was administered(Two hours after labor)