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Набор скоро начнётся NCT07451691

The Effect of the World Health Organisation-Based Intrapartum Care Model on Labour Pain, Comfort, Satisfaction and Postpartum Depression

Без фазы С лечением 18 Years and Older Term Pregnancy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: WHO-ICARE Trial.
Кому может быть актуально
Состояния в реестре: 18 Years and Older, Term Pregnancy. Базовые параметры: 18 лет — 49 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

The Effect of the World Health Organisation-Based Intrapartum Care Model on Labour Pain, Comfort, Satisfaction and Postpartum Depression: A Randomised Controlled Trial

Обзор

This randomized controlled trial aims to evaluate the effects of the World Health Organization-based intrapartum care model on labour pain, labour comfort, childbirth satisfaction, and postpartum depression. The intrapartum care model emphasizes woman-centred, respectful, and supportive care throughout labour, promoting continuous support, effective communication, and active involvement of women in decision-making processes. Although this approach has been associated with improved labour experiences, including reduced pain, increased comfort and satisfaction, evidence from randomized controlled trials evaluating these outcomes together with postpartum depression in a comprehensive framework remains limited. This study seeks to provide high-quality evidence on the impact of the intrapartum care model on maternal childbirth experience and postpartum mental health.

Подробное описание

Approximately 140 million births occur worldwide each year, most of which arise from pregnancies without initial risk to the mother or the newborn. Nevertheless, labour represents a critical period for maternal and neonatal survival, as complications that may develop during this process can substantially increase morbidity and mortality risks. Therefore, the quality of care provided during childbirth is of vital importance. Continuous, woman-centred support during labour is closely associated with positive childbirth experiences.

Negative experiences encountered by women in health facilities during childbirth may render the birth experience distressing, and disrespectful or abusive attitudes from care providers can further exacerbate this situation. A positive childbirth experience is largely related to the extent to which women's expectations and preferences are met, while discrepancies between expectations and experiences may result in childbirth dissatisfaction. Moreover, negative childbirth experiences increase the risk of postpartum depression, anxiety, and post-traumatic stress symptoms. Postpartum depression is a common mental health problem among women after childbirth and adversely affects mother-infant bonding, breastfeeding, and family relationships. In this context, respectful and supportive care during labour is considered to have a protective effect against postpartum depression.

Although various interventions have been developed to support positive childbirth experiences, a standardized childbirth care model has not yet been fully established. In response to this need, the World Health Organization introduced the intrapartum care model in 2018, emphasizing woman-centred, respectful, and supportive care. This model conceptualizes childbirth not only as a physiological process but also as an experience in which women's rights and dignity must be preserved. The intrapartum care model prioritizes respect for women's rights, effective communication, continuous support, avoidance of unnecessary interventions, and the optimization of maternal and neonatal health and comfort.

The intrapartum care model aims to provide individualized and supportive care, promoting continuous communication and shared decision-making throughout labour. Evidence suggests that this approach reduces labour pain, enhances comfort, improves maternal and neonatal outcomes, and positively influences childbirth experiences, thereby supporting postpartum psychological well-being. Childbirth satisfaction, which reflects the degree to which women's expectations and needs are met, is a key indicator of childbirth quality. Additionally, labour pain is a critical factor directly influencing childbirth experience, with supportive care being associated with lower perceived pain and higher levels of comfort.

Despite existing studies examining the effects of intrapartum care practices on labour pain, comfort, or satisfaction individually, randomized controlled trials evaluating these outcomes together with postpartum depression within a comprehensive framework remain limited. Furthermore, high-quality evidence assessing the effects of the World Health Organization-recommended intrapartum care model on childbirth experience and postpartum mental health is insufficient. Therefore, this randomized controlled trial aims to evaluate the effects of the World Health Organization-based intrapartum care model on labour pain, labour comfort, childbirth satisfaction, and postpartum depression.

Вмешательства

  • Поведенческое WHO-ICARE Trial
    Participants in the intervention group will receive continuous, individualized, and woman-centred midwifery care based on the World Health Organization intrapartum care model throughout labour and childbirth. This intervention includes continuous physical and emotional support, effective communication, provision of timely information, encouragement of shared decision-making, respect for privacy and dignity, and avoidance of unnecessary medical interventions. Supportive care will be provided cons

Первичные конечные точки

  • Visual Analog Scale (VAS) [Срок оценки: 60-120 minutes]
Вторичные конечные точки (2)
  • Birth Comfort Scale (BCS) [Срок оценки: 60-120 minute]
  • Birth Satisfaction Scale - Short Form (BSS-S) [Срок оценки: 60 minuteShort Form of the Birth Satisfaction Scale (DMÖ-K)]

Критерии участия

Критерии включения

  • Age: 18 years and older

Gestational status: Term pregnancy

Критерии исключения

  • those with psychological problems

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 2 центра
  • Kahramanmaraş Sütçü İmama Universty — Kahramanmaraş
  • Kahramanmaraş Sütçü İmama Universty — Kahramanmaraş

Идентификаторы

NCT: NCT07451691 · KahramanmaraşSIUI11

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗