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临床试验/NCT06011096
NCT06011096已完成不适用

The Effect of Skin-to-Skin Contact and Delayed Cord Clampingon Placental Separation Time, Separation Method, Amount of Postpartum Bleeding and Postpartum Comfort

Bahar GÖBEL1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2022年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
126
试验地点
1
主要终点
Skin-to-skin contact and delayed cord clamping affect placental separation time.

研究概览

简要总结

It is aimed to determine the late cord clamping with early skin-to-skin contact in primiparous pregnant women who delivered vaginally, according to placental separation time, separation method, amount of postpartum bleeding and postpartum comfort.

详细描述

The research is an experimental type randomized controlled trial. The data of the research gathered in the delivery room clinic of Erzurum City Hospital affiliated to the Ministry of Health in Erzurum city center between 02.11.2022 and 10.06.2023. The study was completed with 126 primiparous pregnants, 63 of whom were controls and 63 of whom were experimental, randomized in the clinic. "Personal Information Form" and "Postpartum Comfort Scale" prepared by the researcher were used to collect the data of the study.

control group

  • Pregnant women who met the criteria for admission to the delivery room were selected, the institution's routine policies were implemented.
  • The mother was informed about the study and written consent was obtained.
  • Hospital routine practices continued until birth.
  • The stopwatch is started the moment the baby is born.
  • After birth, the umbilical cord was clamped immediately without skin-to-skin contact between the mother and the baby, and the baby was taken to routine care.
  • Signs of placental separation were monitored with a stopwatch, and it was noted at what minute the symptoms were seen.
  • Placental delivery time and separation type were noted in the relevant part of the form.
  • According to the routines taken from each hospitalized patient in institutional policies, the volunteer's entry hemoglobin and hematocrit values were noted on the form.
  • The Personal Information Form consisting of 22 questions and the Postpartum Comfort scale were administered to the mother at the end of the follow-up period in the delivery room (2 hours later).
  • From the 6th hour blood values found in the hospital routine, the mother's hemoglobin and hematocrit values were noted on the form.

Experimental group

  • Pregnant women who met the criteria for admission to the delivery room were selected, the institution's routine policies were implemented.
  • The mother was informed about the study and written consent was obtained.
  • Hospital routine practices continued until birth.
  • The stopwatch is started the moment the baby is born.
  • The baby was placed on the mother's chest, it was waited for 60-90 seconds in skin-to-skin contact, and breastfeeding was tried. At the end of the period, the umbilical cord was clamped and the baby was placed under a radiant heater and routine care was continued.
  • Signs of placental separation were monitored with a stopwatch, and it was noted at what minute the symptoms were seen.
  • Placental delivery time and separation type were noted in the relevant part of the form.
  • According to the routines taken from each hospitalized patient in institutional policies, the volunteer's entry hemoglobin and hematocrit values were noted on the form.
  • During the repair of episiotomy or desuria, if any, in the mother, skin-to-skin contact was made between the baby and the mother for 1 hour without disrupting the procedures.
  • The Personal Information Form consisting of 22 questions and the Postpartum Comfort scale were administered to the mother at the end of the follow-up period in the delivery room (2 hours later).
  • From the 6th hour blood values found in the hospital routine, the mother's hemoglobin and hematocrit values were noted on the form.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • for pregnant women
  • Those who agreed to participate in the research
  • 18-49 years old
  • Firstborn (nulliparous)
  • Have 37-42 weeks of pregnancy
  • The baby in head presentation
  • No prenatal risk pregnancy
  • No risk during and after birth
  • for newborns
  • Absence of any health problems or congenital diseases,
  • No need for resuscitation after birth.
  • APGAR score of 8 points or more

排除标准

  • Births less than 37 weeks
  • Multiparity
  • Any complications in the mother or baby
  • Removal of the placenta by intervention rather than spontaneous separation

结局指标

主要结局

Skin-to-skin contact and delayed cord clamping affect placental separation time.

时间窗: 0-30 minute

It shortens the placental separation time in women who have had a vaginal delivery with skin-to-skin contact and delayed clamping of the cord.

Skin-to-skin contact and delayed cord clamping have no effect on the type of placental separation.

时间窗: 0-30 minute

Determination of the effect of skin-to-skin contact and delayed cord clamping on the type of placental separation.

Skin-to-skin contact and delayed cord clamping affect the level of postpartum comfort.

时间窗: 2 hours

Increasing the postpartum comfort level of women who had vaginal delivery with skin-to-skin contact and delayed cord clamping.

Skin-to-skin contact and delayed cord clamping affect the amount of postpartum bleeding.

时间窗: 0-6 hours

Skin-to-skin contact and delayed cord clamping reduce the amount of postpartum hemorrhage in women who deliver vaginally.

次要结局

未报告次要终点

研究者

发起方
Bahar GÖBEL
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bahar GÖBEL

Midwife

Ataturk University

研究点 (1)

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