Clinical trial NCT06660615: The Effect of Continuous Midwifery-led Care in Birth Management
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Labour Pain
Respectful Motherhood Care
Birth Duration
Comfort of Birth
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Effect of Midwife-Led Care on Perception of Labour Pain, Duration of Labour, Comfort of Birth and Respectful Maternity Care
timeFrame: 1 years
measure: Birth Pain
timeFrame: 1 years
measure: birth monitoring
timeFrame: 1 years
measure: Comfort of Birth
timeFrame: 1 years
Secondary outcomes:
measure: Respectful Maternity Care
timeFrame: 1 years
Other outcomes:
Locations:
city: Mardin
country: Turkey
facility: Mardin Nusaybi̇N State Hospital
Study officials:
References:
citation: Visser GHA, Ayres-de-Campos D, Barnea ER, de Bernis L, Di Renzo GC, Vidarte MFE, Lloyd I, Nassar AH, Nicholson W, Shah PK, Stones W, Sun L, Theron GB, Walani S. FIGO position paper: how to stop the caesarean section epidemic. Lancet. 2018 Oct 13;392(10155):1286-1287. doi: 10.1016/S0140-6736(18)32113-5. No abstract available.