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临床试验/NCT07531758
NCT07531758已完成不适用

Evaluation of the Effect of Immediate and Early Skin-to-Skin Contact After Cesarean on Maternal and Neonatal Parameters in the First 24 Hours: A Quasi-Experimental Study Design

Çankırı Karatekin University1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2018年9月20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
92
试验地点
1
主要终点
Maternal hemorrhage

研究概览

简要总结

This study was carried out as a quasi-experimental study to determine the effects of immediate and early skin-to-skin contact (SSC) applied between mother and newborn after cesarean on breastfeeding, anxiety, bleeding and newborn health in the first 24 hours. The application of the study carried out in the cesarean operating room and gynecology services of a private hospital. The required institutional permission and ethics committee approval was received. The sample consisted of 92 mother-infant couples totally, 30 of whom selected to immediate skin-to-skin contact (ISSC), 29 of whom selected to early skin-to-skin contact (ESSC), 33 of whom selected to the control group. The data was collected using Prenatal and postnatal data collection form, Breastfeeding Assessment Tool Scale (IBFAT), The State-Trait Anxiety Inventory and Maternal and newborn follow-up chart for the first 24 hours postpartum. In ISSC group, skin contact was applied within the first 5 minutes after cesarean, and applied to the ESSC group within the first hour after cesarean, and skin contact lasted 40 minutes. The data stored in the SPSS 24 program. In the analysis of the data, Independent Sample-t test, ANOVA test, Paired Sample-t test, Mann-Whitney U test, Kruskal-Wallis H test, Wilcoxon test, Bonferroni correction, Pearson and Spearman correlation coefficient and χ2 test used.

详细描述

Purpose and type of study This research is a quasi-experimental study conducted to examine the effects of immediate and early skin-to-skin contact between mother and newborn after cesarean section on the mother's breastfeeding, anxiety, bleeding, and newborn health in the first 24 hours.

Universe and sample The study was conducted in the postpartum clinics and cesarean section operating room of a private hospital in Ankara. The study was carried out between September 2018 and November 2019 after obtaining the necessary written permissions. To determine the sample number for the study, a pilot study was performed with a total of 15 mother-infant pairs, with 5 pairs in each group. As a result of the pilot study, using the G*Power 3.0.10 program with 80% power, 5% error and the determined 0.15 effect size, at least 87 mother-infant pairs were found to be sufficient for the total study sample size (n1:29; n2:29; n3:29). The sample for the study included a total number of 92 mother-infant pairs with 30 in the ISSC group, 29 in the ESSC group and 33 in the control group. Considering possible losses, the sample included 5% more mother-infant pairs than the lower limit of the sample number.

Women who presented for cesarean section and met the sampling criteria were identified. After being informed of the study's purpose and importance, they agreed to participate. Assignment of women to groups was done using sealed envelopes. For this purpose, one envelope contained a slip of paper labeled "immediate skin-to-skin contact group," another "early skin-to-skin contact group," and a third "control group." Participants were asked to draw a slip of paper from a single envelope to determine their study group. Based on the results, participants were assigned to the immediate skin-to-skin contact group, the early skin-to-skin contact group, and the control group. The study sample consisted of 92 mother-baby pairs in total: 30 in the early skin-to-skin contact group, 29 in the late skin-to-skin contact group, and 33 in the control group. A total of 247 cases were interviewed during the study. A total of 155 cases were lost due to reasons such as the cases not meeting the study criteria (n:98), not volunteering to participate in the study (n:34), the newborn going to the intensive care unit (n:5), the newborn being placed in a post-natal hood (a transparent box in which the entire head of the newborn is placed, most commonly used in neonatal oxygen therapy) (n:10), the mother having nausea, vomiting and pain (n:6), and the mothers forgetting to collect the sanitary pads (n:2).

Inclusion and Exclusion Criteria for the Study

Inclusion criteria for mothers:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

入选标准

  • For mothers:
  • Scheduled cesarean section before spontaneous contractions begin
  • Receiving epidural or spinal anesthesia
  • Nulliparous
  • Singleton pregnancy
  • Age 18 and over
  • Gestational age 37-42 weeks
  • No known health problems (diabetes, gestational diabetes, hypertension, preeclampsia, renal failure, cardiac problems, psychiatric disorders, etc.)
  • No contraindications to breastfeeding (no human T-cell lymphotropic virus (HTLV-1), human immunodeficiency virus (HIV), or active tuberculosis) Speaking Turkish
  • For neonates:
  • Birth weight 2500-4000 gr.
  • Being between 7 and 5 minutes old
  • Having an APGAR score of 7 or higher at 1 and 5 minutes
  • Not having any health problems or congenital anomalies
  • Not having conditions that prevent sucking, such as frenulum (tongue tie) or palate problems

排除标准

  • Mothers whose general condition and vital signs deteriorate during skin-to-skin contact
  • Neonates who experience respiratory and circulatory problems during skin-to-skin contact
  • Neonates admitted to intensive care within the first 24 hours
  • Mothers who do not accumulate pads or diapers

研究组 & 干预措施

Skin to skin contact

Experimental

干预措施: skin to skin contact (Behavioral)

结局指标

主要结局

Maternal hemorrhage

时间窗: Within 24 hours after cesarean section

Total Maternal hemorrhage (grams) amounts were measured in all groups at 24 hours postpartum.

Breastfeeding Assessment Tool Scale (IBFAT)

时间窗: Within 24 hours after cesarean section

IBFAT administered to women at the first beastfeeding and postpartum 24th hour to assess breastfeed success.

The State-Trait Anxiety Inventory (STAI)

时间窗: Postpartum 2nd hour

Mothers asked to fill out STAI at postpartum 2nd hour for all groups to assess the anxiety levels.

Body temperature of newborns

时间窗: Within 24 hours after cesarean section

Body temperatures (°C) of newborns were measured with thermometer.

Heart rates of newborns

时间窗: Within 24 hours after cesarean section

Heart rates per minute of newborns were measured with pulse oximeter.

Peripheral oxygen saturation of newborns

时间窗: Within 24 hours after cesarean section

Peripheral oxygen saturation (%) of newborns were measured with pulse oximeter.

Respiratory rate of newborns

时间窗: Within 24 hours after cesarean section

Respiratory rate per minute of newborns were measured.

Blood glucose levels of newborns

时间窗: Postpartum 2nd hour

Blood glucose levels (mg/dL) of the newborns were measured with glocometer.

次要结局

  • Newborns' weight loss(Postpartum 24th hour)

研究者

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

Esra Arslan Gürcüoğlu

Assistant Professor

Çankırı Karatekin University

研究点 (1)

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