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临床试验/NCT06753058
NCT06753058已完成不适用

ERAS Protocol on Maternal and Fetal Outcomes Following Elective Cesarean Section: a Controlled Trial

Gazi University2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
450
试验地点
2
主要终点
improved maternal recovery in term of ObsQoR in the ERAS pathway

研究概览

简要总结

The goal of this observational study is to investigate the maternal, fetal, and neonatal outcomes in parturients scheduled to undergo elective cesarean section (CS) receiving either standard care or enhanced recovery after surgery (ERAS) protocol.

Primary purpose is to learn if implementing ERAS protocol can improve maternal outcomes in pregnant women aged greater than 18 years scheduled to undergo elective CS under spinal anesthesia using patient reported outcome mesaure (PROM).

Secondary purpose is to learn if implementation of maternal ERAS protocol can improve neonatal outcome in terms of nutrition and breastfeeding.

The main questions that aims to answer are maternal recovery outcome measure determined by obstetric quality recovery score (ObsQoR) which has been known as a patient reported outcome mesaure (PROM) and neonatal outcome assessed by pediatricians.

Primary outcome measure is improved maternal recovery in term of ObsQoR in the ERAS pathway.

Secondary outcome measure is improved neonatal outcome in terms of nutrition and breastfeeding in the ERAS pathway.

详细描述

Methods After obtaining approval of the institutional ethics committee (Decision number: 502/Date: 31.05.2021) and written informed consent from the parturients, data were collected prospectively in 450 ASA II or III term pregnant women aged ≥18 years scheduled to undergo elective CS under spinal anesthesia between June 2021 and June 2023. Gazi University Hospital, which is a re-accredited tertiary care referral center by ESAIC (European Society of Anaesthesiology and Intensive Care), has an annual rate of approximately 1400 deliveries. Parturients younger than <18 years old with fetal compromise, ASA IV or V physical status and emergency cases were not included in this study. The ERAS protocol introduced for our unit was adapted from the SOAP. Following approval of the ERAS protocol by the obstetric team and the participants, two groups were assigned as; ERAS group (n=150) and control group (n=300) who would receive standard care of the unit. The data of the parturients having standard care were compared with those who were enrolled in the ERAS pathway.

Features of ERAS implementation and standard care in the study Step 1. Preoperative (Antepartum) Components

  1. Enrolled patients were seen in the antenatal clinic to give face to face education including information about fasting, CS and/or anesthesia, antimicrobial prophylaxis, skin washing, breastfeeding preparation and support by the principal researcher anesthesiologist for ERAS pathway to improve patient understanding and engagement in their own care.
  2. Principally fasting 6 hours (h) for solids and 2 h for clear fluids was provided. To standardize fasting duration according to the scheduled time of surgery in the ERAS group, parturients who were scheduled for CS before 12:00 PM were allowed to have breakfast at 2:00 AM, while the rest scheduled for CS after 12:00 PM were allowed to have breakfast at 6:00 AM. On the morning of surgery, parturients either diabetic or non-diabetic in the ERAS implemented group were given a carbohydrate solution prepared by the principal researcher anesthesiologist containing 25 g of maltodextrin in 330 mL approximately 2 h prior to surgery.

The control group fasted after 12:00 AM regardless of the scheduled CS time and no carbohydrate solution was administered prior to surgery. 3. Anemia screening and treatment for hemoglobin optimization was done in both groups.

Step 2. Perioperative (Intrapartum) Components

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • American Society of Anesthesiologists (ASA) II or III term pregnant women aged ≥18 years scheduled to undergo elective CS under spinal anesthesia between June 2021 and June 2023 in Gazi University

排除标准

  • Parturients younger than <18 years old with fetal compromise, ASA IV or V physical status and emergency cases, medical contraindication to regional anesthesia particularly spinal block

结局指标

主要结局

improved maternal recovery in term of ObsQoR in the ERAS pathway

时间窗: From enrollment to the end of ERAS or control postpartum 24 hours

Primary outcome measure is described as maternal recovery outcome measure determined by obstetric quality recovery score (ObsQoR) which has been known as a patient reported outcome mesaure (PROM) and neonatal outcome assessed by pediatricians. ObsQoR-11 scores with Likert scale corresponds to; zero being very poor and 110 being excellent

次要结局

  • implementation of maternal ERAS protocol improves newborn nutrition and breastfeeding(From enrollment to the end of ERAS or control postpartum 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Berrin Gunaydin

Professor, MD, PhD

Gazi University

研究点 (2)

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