跳至主要内容
临床试验/NCT04965779
NCT04965779Unknown不适用

The Effect of Abdominal Binder Use on Postpartum Pain, Bleeding, and Breastfeeding Success in Women Who Undergo Cesarean Delivery

Cukurova University2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2020年9月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
128
试验地点
2
主要终点
Postpartum pain evaluation for cesarean section incision

研究概览

简要总结

The aim of this randomized controlled interventional study is to identify the effect of the use of an abdominal binder on postpartum pain, bleeding, and breastfeeding success in primiparous women who have undergone planned cesarean delivery with spinal anesthesia.

详细描述

A 2015 report by the World Health Organization (WHO) has emphasized that cesarean section can be effective in preventing maternal and perinatal mortality and morbidity when there is a life-threatening danger to the mother and/or fetus, but provides no benefit to the woman or the baby otherwise. It also states that the ideal cesarean section rate 10% to 15%, and a rate above 10% at the population level is ineffective in decreasing maternal and infant mortality. However, current cesarean rates are much higher than recommended, especially in developed western countries, and rates ranging from 14.8% (Israel) to 54.8% (Turkey) have been reported as of 2018. Turkey, with a rate of 54.8%, has the highest cesarean section rate among the reported data.

Cesarean delivery is common worldwide and presents many maternal and neonatal risks. While bleeding is the most serious of these risks, the women also experience severe pain and face problems with breastfeeding. The risk of a postpartum bleeding complication is reported to be 2.5 times higher in women who have undergone a planned cesarean section. The rate of experiencing any pain after a cesarean section has been reported as 77% to 92.7% while the incidence of moderate/severe pain is 15.2% to 52.2%. In addition, the probability of experiencing breastfeeding problems in the post-cesarean period is reported to be approximately 7 times higher.

The need for optimum care in the postpartum period in order to protect the health of both the mother and the newborn, and also to prevent the health problems that may develop in the short and long term has been emphasized. Appropriate interventions of the nurses who are in close contact with the women, the newborns, and the families during the postpartum period affect the quality of care significantly. Based on this information, the various effects of the post-cesarean use of an abdominal binder, which is a noninvasive nursing intervention, has been evaluated in the literature and shown to have various benefits in the management of postpartum complications and problems after cesarean section in women with various characteristics. A limited number of studies have reported that the use of an abdominal binder decreases pain but inconsistent effect on postpartum bleeding. However, there is no study evaluating the effect of abdominal binder use on breastfeeding success.

The study was planned as a randomized controlled interventional study with the women randomly divided into intervention (abdominal binder) and control groups. A preliminary application was used to determine the sample size of the study. Based on the power analysis performed with the data obtained, a total of 128 women were included in the study with 64 women in each group, at a confidence interval of 95%, power of 90%, and α level of 0.05.

Block random sampling method was adopted to recruit participants. In order to randomly assign the participants to the groups, a list of 1:1 random numbers was created with the software Research Randomizer (https://www.randomizer.org/) on the computer. Participants were assigned to groups by 8-block randomization method. Randomization was done by an expert statistical consultant who was not responsible for conducting the study. The determined randomization number of list was printed out separately and sealed in each envelope. The random number was hidden in sealed envelopes until participants approved to participate in the study. Writing the random numbers on the papers, placing them in the envelopes and opening the paper in the sealed envelopes were done by an independent volunteer who was not responsible for the conduct of the study. Those who meet the inclusion and exclusion criteria and approve to participate in the study was allocated to intervention (abdominal binder) group or control group according to the result of randomization. In order to prevent bias each participant in the groups was followed in different rooms from the other participants in the group to which they were assigned.

研究设计

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

入排标准

年龄范围
19 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Can read and write in Turkish,
  • Conscious and cooperating,
  • Aged ≥19 to <35 years,
  • At the ≥38th gestational week,
  • Primiparous,
  • With a healthy, singleton pregnancy and fetus,
  • Scheduled to undergo cesarean delivery under spinal anesthesia and then undergoes the procedure,
  • A minimum blood hemoglobin level of ≥11 g/dl and minimum hematocrit ratio of ≥36% at the time of cesarean delivery,
  • Has the infant with her from cesarean delivery until discharge

排除标准

  • A maternal systemic disease,
  • A chronic pain problem or regular use of pain medications,
  • A psychiatric disease,
  • Scheduled to undergo or has undergone any intervention or drug administration in the pre-/intra-/post-operative period,
  • Development of any complication in the pre-/intra-/post-operative period,
  • Drain placement in the postpartum period

结局指标

主要结局

Postpartum pain evaluation for cesarean section incision

时间窗: Since postpartum arrival to the clinic (postpartum hour 1) up to 48 hours

Postpartum pain level evaluation for cesarean section incision in this study is determined using Visual Analog Scale \[VAS\]. VAS is a self-report tool used in the subjective assessment of pain. It is in the form of a 10 cm (100 mm) ruler with no pain at one end (minimum pain score=0) and the most severe pain at the other end (maximum pain score=10). The patients indicate the level of pain they perceive by pointing in accordance with their situation. The numerical data of the pain level of the individual is obtained by measuring the distance from the tip where there is no pain to the specified point with a ruler. The score is increased pain level increases. In the study conducted to ensure the standardization of the VAS, it is reported that the vertical use is better understood by the patients. The VAS has been used in many studies evaluating postoperative cesarean delivery pain. In this study, women's VAS scores were evaluated with a vertical form.

次要结局

  • Puerperal bleeding amount measurement(Since postpartum arrival to the clinic (postpartum hour 1) up to 48 hours)
  • Breastfeeding success evaluation(Since postpartum arrival to the clinic (postpartum hour 1) up to 48 hours)
  • Postpartum hemoglobin level and hematocrit ratio(Up to postpartum 24th hours)
  • Postpartum pain evaluation for abdomen(Since postpartum arrival to the clinic (postpartum hour 1) up to 48 hours)

研究者

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

Kara Pınar

Research Asisstant

Nigde Omer Halisdemir University

研究点 (2)

Loading locations...

相似试验