Obstetric and Genecology, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.
Low Cost Effective Care Unit, Christian Medical College and Hospital Vellore, Vellore, Tamil Nadu, India.
BMJ Open. 2022 Dec 19;12(12):e063497. doi: 10.1136/bmjopen-2022-063497.
In a large developing country, with diverse population characteristics and differential access to healthcare, it is important to identify factors that influence postnatal health. This knowledge will help frame recommendations to enhance universal postnatal care.
A prospective cohort study will be conducted by recruiting all participants who deliver in a referral centre in South India during a 1-year period after written consent is obtained from them. In addition to clinical information pertaining to their delivery and demographics, details of physical health, mental health socioeconomic status and emotional support will also be collected. Every participant will be followed up physically and/or by telephonic consultation at 3, 9 and 18 months of their postnatal period to reassess their status and that of their babies. As there are several independent and dependent variables requiring multivariate analysis, a sample size of 10 000 is considered adequate. Any unplanned visits to a health facility will be enquired into and documented for analysis.During data analysis, the effect of Caesarean section, high-risk characteristics and gestational age of the baby at delivery on various outcome measures and postnatal status will be evaluated. Interpretation of the large volume of collected data will help frame recommendations to improve postnatal care ETHICS AND DISSEMINATION: The study is approved by the Institutional Review Boards (Research and Ethics Committees) of Christian Medical College, Vellore, Tamil Nadu, India (IRB 12178 date 24 June 2020).Women are provided with a detailed information sheet and written consent is obtained. They are reassured that their care will not be compromised if they do not consent to the study. Data will be available on the clinical trial portal to assist in the dissemination of results after the project is published.
CTRI/2022/03/041343.
在一个人口特征多样、医疗保健获取情况存在差异的发展中大国，确定影响产后健康的因素很重要。这方面的知识将有助于提出建议，以加强普遍的产后护理。
通过在印度南部的一家转诊中心招募所有在 1 年内分娩的参与者，进行一项前瞻性队列研究。除了与分娩和人口统计学相关的临床信息外，还将收集身体健康、心理健康、社会经济地位和情感支持的详细信息。每个参与者将在产后 3、9 和 18 个月通过身体检查和/或电话咨询进行随访，以重新评估他们的状况和他们的婴儿的状况。由于需要进行多元分析的独立和依赖变量有几个，因此认为 10000 人的样本量足够。将询问并记录任何计划外的就诊情况，以便进行分析。在数据分析过程中，将评估剖宫产、高危特征和分娩时婴儿的胎龄对各种结局测量和产后状况的影响。对收集到的大量数据的解释将有助于提出建议，以改善产后护理。
该研究已获得印度泰米尔纳德邦维洛尔基督教医学院的机构审查委员会（研究和伦理委员会）的批准（IRB 12178，日期为 2020 年 6 月 24 日）。向妇女提供详细的信息表，并获得书面同意。如果她们不同意参加研究，向她们保证不会影响她们的护理。项目发表后，将在临床试验门户网站上提供数据，以协助结果的传播。
CTRI/2022/03/041343。
