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临床试验/NCT07514195
NCT07514195已完成不适用

THE EFFECTS OF MOTHER FRİENDLY PRACTİCES ON MATERNAL AND FETAL OUTCOMES: A MULTİCENTER STUDY

Sakarya University1 个研究点 分布在 1 个国家目标入组 281 人开始时间: 2025年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
281
试验地点
1
主要终点
Composite adverse maternal and neonatal outcome

研究概览

简要总结

The "mother-friendly hospital" model aims to enhance care quality by avoiding unnecessary, non-evidence-based interventions and supporting natural physiological processes from early pregnancy to postpartum. This study evaluated the impact of mother-friendly hospital criteria on labor pain, maternal satisfaction, and maternal and fetal outcomes.

Mother-friendly hospital practices emphasizing minimal intervention and physiologic support reduce labor pain, improve maternal satisfaction, and enhance neonatal outcomes. Implementing mother-friendly approaches ensures safe, high-quality, mother-centered maternity care.

The results of our study showed that mother-friendly approaches increased maternal satisfaction during the childbirth process and reduced pain scores. These results revealed that mother-friendly practices not only improve the childbirth experience of women but also contribute positively to maternal and neonatal health. Therefore, supporting and expanding the integration of mother-friendly approaches into the healthcare system is of great importance for improving the quality of obstetric services.

详细描述

This prospective study included term pregnant women delivering between February and June 2025 at Sakarya Research and Training Hospital (Group 1, with mother-friendly practices) and Ümraniye Research and Training Hospital (Group 2, without such practices). Exclusion criteria were maternal age >45 years, chronic systemic disease, preeclampsia or gestational diabetes, prolonged rupture of membranes with infection, preterm birth (<37 weeks), and small-for-gestational-age infants (<2 SD). Maternal characteristics, labor interventions, non-pharmacological methods, postpartum hemorrhage, labor duration, pain levels using the Visual Analog Scale (VAS), and fetal outcomes (birth weight, Apgar scores, NICU admission) were recorded. Maternal satisfaction was assessed in the first postpartum hour using the Birth Satisfaction Scale.

A total of 281 women were included (Group 1: 136, Group 2: 145). Groups were similar in age, BMI, education, employment, gestational week, labor duration, and postpartum hemorrhage (p>0.05). Latent phase, active phase, and postpartum VAS scores were significantly lower in Group 1 (p<0.001). Maternal satisfaction scores were higher in Group 1 (p<0.001). NICU admissions were lower in Group 1 (2.9% vs. 9.7%, p=0.022), and first- and fifth-minute Apgar scores were higher (p<0.001).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients aged 18-45
  • No chronic diseases
  • No acute illnesses
  • No pregnancy complications
  • Spontaneous pregnancy
  • Full-term pregnancy
  • Appropriate-for-gestational-age (AGA) infants

排除标准

  • Individuals over 45 years of age
  • Maternal type 1 and 2 diabetes mellitus or gestational diabetes
  • Chronic hypertension
  • Preeclampsia
  • Connective tissue disease
  • Smoking during pregnancy
  • Preterm birth (gestational age <37 weeks)
  • small-for-gestational-age infants (birth weight < 2 SD)
  • neonatal asphyxia (APGAR score <7 at 1 and 5 minutes)
  • malformations, chromosomal disorders, and congenital infections
  • women with signs of chorioamnionitis (fever, leukocytosis, abdominal pain, foul-smelling discharge) more than 12 hours after EMR
  • chronic kidney and liver disease
  • hematological disorders
  • Should not be administered to individuals with a pacemaker
  • Should not be administered to patients with epilepsy, transient ischemic attacks, or a history of cerebrovascular events

研究组 & 干预措施

Group 1

where mother-friendly approaches were implemented

Group 2

where mother-friendly approaches were not implemented

结局指标

主要结局

Composite adverse maternal and neonatal outcome

时间窗: From delivery to hospital discharge, 1. day

A composite outcome including at least one of the following: cesarean delivery, postpartum hemorrhage, severe perineal trauma, low 5-minute Apgar score (\<7), or NICU admission.

次要结局

未报告次要终点

研究者

发起方
Sakarya University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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