The Effect of Continuous Midwifery-led Care in Birth Management

NCT06660615 | Completed

• 1 other identifier: 2023/1191
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

Labour Pain; Respectful Motherhood Care; Birth Duration; Comfort of Birth

Outcome Measures

Primary Outcomes (4)

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

  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.

  1 years

• Birth Pain

  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).

  1 years

• birth monitoring

  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.

  1 years

• Comfort of Birth

  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).

  1 years

Secondary Outcomes (1)

• Respectful Maternity Care

  1 years

Study Arms (2)

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).

Behavioral: MIDWIFE-LED CARE

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.

Interventions

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).

Receiving midwife-led care

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: WOMEN IN LABOUR
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Mardin Nusaybi̇N State Hospital

Mardin, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 30322563 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know which group they are in, so they will be blind to differences in the interventions.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 28, 2024
• Study Start: October 17, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: February 21, 2025

Record last verified: 2024-10

Locations

TU (1)