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渥太华营养指南对妊娠期恶心和呕吐的干预:一项随机对照试验方案

Ottawa nutritional guide intervention for nausea and vomiting in pregnancy: a randomized controlled trial protocol.

作者信息

Nazmi Sana, Behmanesh Fereshteh, Nikbakht Hossein-Ali, Esmaeilzadeh Seddigheh

机构信息

Student Research Committee, Babol University of Medical Sciences, Babol, Islamic Republic of Iran.

Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Islamic Republic of Iran.

出版信息

Reprod Health. 2025 Aug 11;22(1):146. doi: 10.1186/s12978-025-02097-9.

Abstract

BACKGROUND

Nausea and vomiting are frequent complaints during pregnancy, which can be accompanied by marital discord and sexual dissatisfaction, in addition to the hospitalization of pregnant women. Given the potential side effects of pharmaceutical treatments on both the mother and fetus, many women prefer non-pharmacological interventions. This study will assess the impact of an educational program based on the Ottawa Nutritional Guide on symptoms in pregnant women and explore sexual satisfaction as a secondary outcome.

METHODS

In this randomized controlled clinical trial, a total of 60 pregnant women aged between 15 and 45 years, who scored 3-16 on the Rhodes Index of Nausea, Vomiting and Retching (RINVR), will be selected via convenience sampling. They will be then divided into two intervention and control groups through block randomization. Data will be collected using a demographic and obstetric checklist, the RINVR, and the Hudson's Index of Sexual Satisfaction (ISS). The intervention group will be received training on the Ottawa Nutritional Guide in two 60-min sessions, conducted in groups of two to five people. The control group, on the other hand, received routine care. The collected data will be analyzed using SPSS Version 22.

DISCUSSION

Several studies have reported the effectiveness of the Ottawa Nutritional Guide in managing nausea and vomiting in pregnant women, as well as its positive impact on their quality of life and marital satisfaction. However, further research is required to validate these findings before considering it as a potential alternative to pharmaceutical methods during pregnancy.

TRIAL REGISTRATION

This study was registered in the Iranian Registry of Clinical Trials (IRCT20180218038783N5, registered 03/09/2023).

摘要

背景

恶心和呕吐是孕期常见的不适症状,除了导致孕妇住院外,还可能伴随婚姻关系不和谐及性方面的不满。鉴于药物治疗对母亲和胎儿都可能产生潜在副作用,许多女性更倾向于非药物干预措施。本研究将评估基于渥太华营养指南的教育项目对孕妇症状的影响,并将性满意度作为次要结果进行探索。

方法

在这项随机对照临床试验中,通过便利抽样选取60名年龄在15至45岁之间、罗兹恶心、呕吐和干呕指数(RINVR)得分在3至16分之间的孕妇。然后通过区组随机化将她们分为两个干预组和对照组。将使用人口统计学和产科检查表、RINVR以及哈德逊性满意度指数(ISS)收集数据。干预组将分两组,每组两至五人,接受两次时长60分钟的渥太华营养指南培训。另一方面,对照组接受常规护理。收集到的数据将使用SPSS 22版本进行分析。

讨论

多项研究报告了渥太华营养指南在管理孕妇恶心和呕吐方面的有效性,以及对其生活质量和婚姻满意度的积极影响。然而,在将其视为孕期药物治疗的潜在替代方法之前,还需要进一步研究来验证这些发现。

试验注册

本研究已在伊朗临床试验注册中心注册(IRCT20180218038783N5,于2023年9月3日注册)。

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