Effect of Cervical Traction on Oxytocin Level and Postpartum Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- postpartum hemorrhage (determined by hemoglobin and hematocrit level)
研究概览
简要总结
The purpose of the research conducted within the scope of the doctoral thesis study is to evaluate the effect of cervical traction applied at the end of the third stage of childbirth on the oxytocin level and postpartum bleeding (hemoglobin level, estimated blood loss, and amount of bleeding measured with a bleeding tracking bag). The study included 100 women in the intervention group and 100 women in the control group, all of whom met the inclusion criteria. Data were collected throughout the research via an Introduction Information Form, Hemoglobin and Hematocrit Measurement, Calculation of Estimated Blood Loss (modified formula of Gross (1983)), Oxytocin Measurement, and Measurement of bleeding amount with the Bleeding Tracking Bag. Blood was drawn twice from all participating women. The hemoglobin levels of the women were determined with these collected blood samples, and the change before and after the application was identified. Additionally, the oxytocin hormone in the blood was also examined. The change in oxytocin hormone levels before and after application, the difference between groups, and the change within the women themselves were identified. Besides this, the Bleeding Tracking Bag was placed under the women after the birth of the fetus and the amount of bleeding was measured. The Bleeding Tracking Bag was placed under the woman after the placenta was expelled, left for 15 minutes, and the amount of blood accumulated in the bag was recorded in "ml". "Hemoglobin and Hematocrit measurement" was performed when the woman was in the obstetrics ward, when cervical dilatation was 10 cm, and at the end of the 6th hour after birth. Blood taken into the purple cap EDTA tube was delivered daily to an external special laboratory. For determining the "oxytocin" level, 5 ml of blood was taken into the gel blood collection tube when cervical dilatation was 10 cm. After placing the bleeding tracking bag under the woman, cervical traction was applied to the intervention group for 90 seconds. To determine the effect on the oxytocin level after 15 minutes (990 seconds) of applying traction, a second 5 ml blood was taken into the gel blood collection tube. The blood taken was centrifuged by the researcher (PhD student) for 10 minutes and separated into its serum. The separated serums were pipetted into a 1.5 ml Eppendorf tube and stored at -80°C after labeling the tubes.
详细描述
The research is a randomized controlled intervention study planned to evaluate the effect of the cervical traction maneuver applied at the end of the third stage of labor on oxytocin level and postpartum bleeding. The population of the research consisted of women who gave birth vaginally in the hospital where the research will be conducted during the research (1100 vaginal births between November 2022 and May 2023). realized). The sample of the study consisted of 202 women who gave birth vaginally, where vacuum and forceps were not used, in a training and research hospital obstetrics clinic in Turkey, who met the sample selection criteria and agreed to participate in the study (Intervention group: 102 women; Control group: 100 women). Two women in the intervention group were excluded from the study due to the diagnosis of placenta acreata. The study was completed with 200 women. The smallest sample size to be taken; In order to find the significant difference between the groups, repeated measure analysis of variance (ANOVA) was determined by performing Power (Gpower) analysis under the test. Because, in the study, three different variables will be measured in order to determine the oxytocin level, hemoglobin and hematocrit level, and the amount of bleeding with the bleeding follow-up bag. In the analysis, 196 cases were found sufficient by taking α=0.05 and f=0.25 with 80% power. The sample size was taken as 200 cases against the possibility of data loss.
Simple Random Numbers Table was used as the randomization method for sample selection. In this method; Randomly sorted algorithm was created at the maximum allowed percentage and 10% deviation in total 100 samples. In the algorithm, 100 sample (female) groups for both groups; Up to 200 randomly sorted as A and B. Intervention group: A, Control group: B. The sample taken according to the order in the list on the data collection days; It was accepted as group A or B (Piantdosi S, 2005; Pocock SJ, 1983; Rosenberger WF, 2002). The primary outcome measure of the RCT study was the difference between the cervical traction group and the control group.
Dependent variables of the research; Oxytocin level, hematocrit and hemoglobin value and amount of bleeding are the independent variables; It is the application of cervical traction.
Data were collected using the Introductory Information Form, the formula for Calculated Blood Loss (Gross's modified formula), measuring the oxytocin level and determining the amount of bleeding using Brass-V Drape (bleeding monitoring bag).
- Introductory Information form:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
Simple Random Numbers Table was used as the randomization method for sample selection. In this method; Randomly sorted algorithm was created at the maximum allowed percentage and 10% deviation in total 100 samples. In the algorithm, 100 sample (female) groups for both groups; Up to 200 randomly sorted as A and B. Intervention group: A, Control group: B. The sample taken according to the order in the list on the data collection days; It was accepted as group A or B (Piantdosi S, 2005; Pocock SJ, 1983; Rosenberger WF, 2002). The primary outcome measure of the RCT study was the difference between the cervical traction group and the control group.
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women aged 18 and over who are not of advanced age
- •Non-risky pregnancies (pregnant women without systemic disease, without placental problems such as placenta previa, without fetal problems (eg: low birth weight, intrauterine growth retardation, macrosomia, presentation disorders), those without obstetric problems
- •Pregnant women who do not have pre-existing maternal hemorrhagic disorders such as factor 8 or 9 deficiency or VonWillebrand disease,
- •Pregnant women with hemoglobin level HB <10 mg / dl and without previous C/S)
- •Pregnant women with live fetuses
- •Pregnant women at term (those who are older than the 37th week of pregnancy and less than the 42nd week of pregnancy)
- •Those who can speak Turkish
- •Pregnant women who gave consent to participate in the study were included.
排除标准
- •It may occur in the first stage of labor; Pregnant women with pathological conditions such as non-progressive labor, abruption of the placenta, rupture, bleeding, cord prolapse, fetal distress, shoulder impingement,
- •Pregnant women who have undergone induction of labor (induction with prostaglandin),
- •It may occur in the second stage of birth; Pregnant women with pathological conditions such as shoulder insertion, bleeding and prolongation in the second stage, fetal distess, difficult delivery, vacuum and forceps application,
- •It may occur in the third stage of birth; bleeding, placental retention, cavity control, third and fourth degree tear, etc. Pregnant women in situations such as
结局指标
主要结局
postpartum hemorrhage (determined by hemoglobin and hematocrit level)
时间窗: While the first blood from the women was cervical dilatation 10 cm, the second blood was taken at 6 hours postpartum.
Hemoglobin, hematocrit, calculated blood loss (Gross's modified formula) and the amount of blood accumulated in Brass V Drape and changes in these parameters of the women in the study before birth (when cervical dilatation was 10 cm) and after birth (6th hour after birth) has been examined.
postpartum hemorrhage (Determined with Bleeding Tracking Bag)
时间窗: After the placenta was expelled, the bleeding monitoring bag was kept under the woman for 15 minutes.
The amount of blood (ml) accumulated in the Brass V Drape within 15 minutes after the expulsion of the placenta after the third stage of labor.
次要结局
- Oxytocin level (pg/dL)(The first blood was taken when the cervical dilation was 10 cm, and the second blood was taken after 15 minutes in the intervention group and after 16 minutes and 30 seconds in the control group.)
研究者
İlkay Ünal
associate professor
Ege University