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Completed

NCT Number: NCT06660615

The Effect of Continuous Midwifery-led Care in Birth Management

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.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mardin Nusaybi̇N State Hospital

Mardin, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

MIDWIFE-LED CARE

Behavioral

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).

Primary outcomes

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

    Time frame: 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.

  2. Birth Pain

    Time frame: 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).

  3. birth monitoring

    Time frame: 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.

  4. Comfort of Birth

    Time frame: 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).

Secondary outcomes

  1. Respectful Maternity Care

    Time frame: 1 years

    Respectful Motherhood Care Scale (RMCS) (ANNEX-5): The scale was developed by Dişsiz et al. in 2023. With the five-point Likert-type scale, it was aimed to evaluate the respectful maternity care perceived by women between the 6th week and 1 year postpartum during pregnancy, birth and postpartum period. The scale consists of a total of 29 items and 3 sub-dimensions with mixed positive and negative statements. The sub-dimensions are 'Consensual Dignified Care (17 items)', 'Psychological Abuse and Care Neglect (7 items)' and 'Physical Violence, Privacy Violation and Discrimination (5 items)'. The highest total score that can be obtained from the scale is 145 and the lowest score is 29. An increase in the score obtained from the overall scale indicates that the woman's perception that she received respectful maternity care during pregnancy, birth and postpartum period increased, while a decrease indicates that the woman's perception that she received respectful maternity care during pregn

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2024
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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