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临床试验/NCT06660615
NCT06660615已完成不适用

The Effect of Midwife-Led Care on Perception of Labour Pain, Duration of Labour, Comfort of Labour and Respectful Maternity Care: a Single Blinded Randomised Controlled Trial

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2024年10月17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
发起方
入组人数
85
试验地点
1
主要终点
The Effect of Midwife-Led Care on Perception of Labour Pain, Duration of Labour, Comfort of Birth and Respectful Maternity Care

研究概览

简要总结

Caesarean section is an emergency procedure necessary to prevent harm or death to the mother or newborn. Worldwide, caesarean section rates are steadily increasing. This increase not only has negative consequences on maternal and child health, but also leads to a reduction in essential resources and impedes access to health services worldwide. The International Federation of Gynaecology and Obstetrics (FIGO) has called for help from government bodies, professional organisations, women's groups and other stakeholders to reduce unnecessary caesarean sections. According to a review of antenatal and intrapartum interventions to reduce caesarean section, promote vaginal birth and reduce fear of childbirth; the importance of support in the intrapartum period is prominent. The National Institute for Health and Care Excellence (NICE) states that this support with a midwife who provides care and one-to-one support to the woman in labour reduces women's anxiety and increases their sense of trust.

详细描述

Vaginal delivery of low-risk pregnancies is best provided and guided by a midwife. It is seen that receiving support from a midwife in the birth of low-risk pregnancies does not increase the risks for the mother or newborn and has many economic and emotional advantages. The World Health Organisation recommends respectful care based on woman-centred care in the intapartum period for a positive birth experience. Respectful Maternity Care has been recognised as a key strategy to improve the quality of maternity care. Although there is no clear consensus on the definition of respectful maternity care, it is generally considered synonymous with intimate and woman-centred care. It is a care approach that emphasises the fundamental rights of women, newborns and families and increases adequate access to evidence-based care while recognising their needs and preferences. In this direction, midwives are expected to add respectful maternity care to their clinical skills in the management of the birth process. In the literature, it is seen that respectful and helpful interaction between women and health professionals during labour creates positive perceptions in women. In the study of Liu et al. (2021), it is stated that midwife-led management of labour leads to the formation of positive perceptions in women. Fear of labour, labour pain and duration of labour in midwife-led care on the behaviour of the students in the study.

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
Single (Participant)

盲法说明

Participants will not know which group they are in, so they will be blind to differences in the interventions.

入排标准

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

入选标准

  • •Pregnant women with spontaneous pregnancy between 38-42 weeks of gestation
  • •single fetus head presentation
  • •first pregnancy
  • •without any pregnancy-related risk status (such as preeclampsia, gestational diabetes)
  • •who were admitted to the delivery room for normal labour will be included in the study.

排除标准

  • •WOMEN WHO CANNOT GIVE BIRTH NORMALLY
  • •WANT TO LEAVE THE LABOUR FORCE

研究组 & 干预措施

Receiving midwife-led care

Experimental

The birth process will be followed by the same midwife from the beginning of the intrapartum period until the birth of the baby and placenta. In this process, positive respectful maternal care will be included in line with the recommendations of WHO (İsbir & Sercekuş, 2017).

干预措施: MIDWIFE-LED CARE (Behavioral)

Midwife-Led Non-Care Receiving Care

No Intervention

Participants in the group will receive routine care normally provided only in the hospital. Within this care, from the beginning of the intrapartum period until the birth of the baby and placenta, the birth process will be followed under the supervision of a midwife or physician who is randomly available within the working conditions of the birth unit.

结局指标

主要结局

The Effect of Midwife-Led Care on Perception of Labour Pain, Duration of Labour, Comfort of Birth and Respectful Maternity Care

时间窗: 1 years

Measurement Tools Information Form (IF) (Appendix 1): This form was prepared in line with the literature (Liu et al., 2021) and includes socio-demographic and obstetric characteristics of the participants.

Birth Pain

时间窗: 1 years

Visual Analog Scale (VAS) (ANNEX-2): The Visual Analog Scale (VAS) was developed by Price et al. in 1983 and is used to measure pain intensity and for pain monitoring. The VAS is 10 cm long and the two ends are named differently. On the scale, '0' indicates no pain and '10' indicates the most severe level of pain. The VAS is a measurement tool that is frequently and reliably used to assess labor pain (Price et al., 1983; Mutlu \& Özkaya, 2021).

birth monitoring

时间窗: 1 years

Birth Monitoring Form (DIF) (ANNEX-3) : It was aimed to evaluate the labour process with the labour monitoring form developed by the researchers. In the birth follow-up form, data obtained from pregnant women in G1 and G2 regarding cervical dilatation and dilatation, duration, frequency and intensity of contractions, time of delivery, and time of placental separation will be recorded.

Comfort of Birth

时间窗: 1 years

Birth Comfort Scale (BCS) (ANNEX-4): It was developed by Kerri Durnell Schuiling in 2003, inspired by Kolcaba's comfort theory. The original version consists of fourteen items. The scale is a five-point Likert-type scale (1= Strongly disagree, 5= Strongly agree). Its Turkish validity and reliability was performed by Potur et al. There are three subscales/factors (environmental, physical, psychospiritual) in the Turkish version of the comfort of labour scale consisting of nine items. Items 2,3,4,6 of the scale are divided into sub-dimensions in the physical dimension, items 7,8 in the psychospiritual dimension and items 1,5,9 in the environmental dimension. A minimum of 9 and a maximum of 45 points can be obtained from the scale. The Cronbach Alpha value of the scale was found to be 0.75 (Potur et al., 2015).

次要结局

  • Respectful Maternity Care(1 years)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Betul Uncu

Lecturer

Istanbul University - Cerrahpasa

研究点 (1)

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